outcome in spasticity

S36 Measures in spasticity management Muscle & Nerve Supplement 6 1997

K E Y P O I N T S

• A wide range of outcome measures existsfor assessingspasticity and theeffectiveness ofintervention

• Most spasticity rating scales areordinal

• Equal intervals between units onan ordinal scalecannot be automaticallyassumed

• Non-interval scaling can beaddressed usingRasch analysis,though care mustbe taken to avoidinappropriate extrapolation

Susan H. Pierson, MD, PT

The development of objective outcome mea-sures in the treatment of spasticity has beendriven more by pressures from academicmedicine and third-party payers than fromwithin the clinical neurology and rehabilita-tive medicine settings in which they areintended to be used. Moreover, their trans-plantation to, and usefulness in, clinicalmedicine has been limited, particularly forthe documentation of non-ordinal data suchas “function,” “movement,” and “pain,”where a narrative format is more commonlyused to describe a patient’s condition andprogress from visit to visit. In recent years,however, an increasing number of voicesfrom within the clinical professions havejoined the call for more valid and repro-ducible scales. Practicing physicians andtherapists now have a range of outcomemeasures from which to choose, with thelikelihood that these will be added to andimproved on as experience with themincreases, and validation studies are per-formed.

Goal of Measurement

The goal of an outcome measure is to allowquantification of physical status and changein a standardized, reproducible way.Measurements can define the severity of theproblem, whether change has occurred overtime, and whether interventions have hadan effect. Standardized measures aredesigned for a specific purpose in a speci-

fied population, with detailed instruction foradministering the measure and interpretingthe scores. Results of reliability and validityinvestigations may be available, which allowcomparison against population norms.

Developing valid and reliable measures hasbeen particularly difficult in the medicalrehabilitation field, because such clinicallyimportant measures as strength, spasticity,pain, and function lend themselves poorlyto ordinal classification. While laboratoryvalues, vital signs, and other numerical dataare far more easily collected and analyzed,their clinical relevance to spasticity is limit-ed.

Definition of Data Type

In the measurement of functional outcomes,data can be classified within levels describedby Wade.40 Nominal measures group data bycategory, such as sex and diagnosis. There isno particular order to the data points, norimplied weighting or value difference amongthem. Ordinal data has some order to it,with scoring weighted in one direction.Virtually all of the measures used to quanti-fy function and most of the scales thatquantify movement and spasticity are ordi-nal.

Two types of ordinal measures exist. Thefirst measures a patient’s performance of aspecific skill, such as the amount of assis-tance required to ambulate, and grades it ona simple one dimensional scale (e.g., “min-

Outcome Measures in Spasticity Management

Abstract: Development of validated and reliable outcome measures for spasticity rehabilitation has been hampered by the difficulty of quantifying function-ally important parameters such as pain, ease of care, and mobility. Nonetheless, a combination of measures designed to assess technical and functional out-comes, patient satisfaction, and the cost effectiveness of treatment can be used together to evaluate status and track change in spasticity management,including treatment programs involving botulinum toxin. While double-blind, placebo-controlled studies remain the gold standard for clinical testing, thesingle-subject design is a useful alternative in many treatment protocols. Because no single tool can measure the many types of changes possible with treat-ment, the choice of assessment tools must be based on the functional changes expected from the treatment. A wide range of assessment tools are criticallyreviewed for their sensitivity, reliability, validity, and ease of administration. © 1997 John Wiley & Sons, Inc.Spasticity: Etiology, Evaluation, Management, andthe Role of Botulinum Toxin Type A, MF Brin, editor. Muscle Nerve 1997; 20 (suppl 6): S36-S60.Key Words: spasticity, spasticity management, outcome measures, study design, patient-centered scales, botulinum toxin

Susan H. Pierson, MD, PT Director of NeurorehabilitationHeather Hill Rehabilitation Hospital12340 Bass Lake RoadChardon, OH 44024

Syllabus A pages 1-120 4/14/98 20:52 Page 36

S37Measures in spasticity management Muscle & Nerve Supplement 6 1997

K E Y P O I N T S

• Ratio scales, such asbefore/after measurements,are useful, reli-able, and easy toadminister

• A technical outcome is anexpected changein a measurablevariable, based onthe technical goalsof a procedure

items on a cognitive scale). It can also occurif the test items are vaguely worded or opento interpretation. Rasch analysis has beenapplied to functional rating scales such asthe Patient Evaluation and ConferenceSystems (PECS),22 and to the Assessment ofMotor and Performance Skills (AMPS),12 ameasure of performance of ADL tasks inoccupational therapy.

Rasch analysis can be avoided altogether ifthe original scale is designed with equalintervals between scores. Such “intervalscales” are parametric without any manipu-lation. The Galveston Orientation andAmnesia Test25 is an interval measure withcognitive items weighted by difficulty andspaced evenly, and then summed to a totalscore. The Sickness Impact Profile (SIP)6 isanother interval scale, and one in which theintervals are derived by asking patients tojudge the relative value of different datapoints. With the SIP, “running with difficul-ty” is given a much higher score than “notwalking at all.”

Ratio scales are also used in measuring func-tion and recovery. Any timed test, such asthe distance ambulated or the number ofpegs placed in 60 seconds, allows the con-struction of a “before/after” ratio. These areuseful and easy to administer in rehabilita-tion practice and are reliable and repro-ducible enough to be used in multicenterclinical trials.

Components of MedicalOutcomes

Goldberg14 suggests that outcomes be evalu-ated by the following four measures:- Technical accomplishment- Functional outcomes- Patient satisfaction- Cost effectiveness

Technical outcomes identify a specific techni-cal goal of a procedure or surgery. It may bethe improvement in range of motion follow-

mod-max”). The second is a multidimen-sional scale where performance on manyitems is ranked individually; these scores arethen added to give an overall score. TheFunctional Independence Measure (FIM)39

and Barthel Index26 are examples of this sec-ond type. In neither type of scale can oneautomatically assume equal intervalsbetween scores, however. The differencebetween 1 and 2 may not be equal in severi-ty or extent of disability to the intervalbetween 6 and 7. Because of this non-inter-val scaling, such ordinal data is not para-metric, meaning it cannot be treated withstandard arithmetic processing such as fre-quency counts and mean calculations.

To overcome this deficiency, a probabilisticmeasurement process such as Rasch analysis18 can be used. This is a mathemati-cal procedure by which the total scores ofsummed interval data (i.e., ordinal data) aredivided in a manner that equalizes the inter-vals. This allows the points on the scale tobe equally spaced and additive.

Rasch analysis can also make two differentscales exhibit unidimensionality, by manipu-lation of scores from the different scaleswhich measure similar areas of function.After Rasch analysis is applied, the scorescan then be analyzed using parametricprocesses. The equal intervals, termed “log-its,” are devised on the basis of probability,such as the probability that a person with agiven level of ability will successfully per-form an activity of daily living (ADL) task.Since the person with more ability has ahigher probability of succeeding at the task,he is assigned a higher score. The equalintervals of logits lend themselves to extrap-olation, and so can compensate for missingdata (since they are based on probabilitiesand not raw scores). Risks of this extrapola-tion include the misfitting of items withinthe extrapolated intervals. Misfitting of itemsmay occur if the items on the scale trulydon’t fit with the process or skill being mea-sured (such as the placement of affective



K E Y P O I N T S

• A functional outcome is anexpected changein a patient'sability to performa task

• Patient satisfaction measures are concerned withboth the resultand the processof care delivery

Campbell8 makes the essential point thatreliable outcome measures allow not onlythe provider, but also the patient and family,to determine which interventions are effec-tive for which conditions. Reliable outcomemeasures are expected to empower con-sumers to make more informed choicesabout their health care, give payers standardexpectations for return on their investments,and direct health care professionals towardsdelivering the most potent and appropriatetherapies for enhancing function and pre-venting further disability.

Study Design

The “gold standard” for clinical testing ofany intervention is the randomized, double-blind, placebo-controlled trial. While thesetypes of trials are relatively easy to use forshort-acting medications such as Sinemet,they can become unwieldy for studies of theefficacy of botulinum toxin (BTX), wheredata collection must extend over at least 6months in order to compare outcomes withand without the treatment intervention.Nonetheless, they have been done, asdetailed by Simpson.38

The single-subject design offers anothermodel for evaluation and research.4,29 Thismethod was developed during the 1970s toaid assessment of educational interventionsin the special needs population. It has notbeen widely used in general medicine, buthas gained some acceptance in the alliedhealth professions, psychology, and rehabili-tative medicine.15 In this model, the subjectunit is the single patient or a small series ofpatients. The intervention is the indepen-dent variable, and the expected outcome(increased range of motion, decreased spas-ticity, increased function) is the dependentvariable. The outcome measure is adminis-tered at repeated intervals and data collect-ed, most appropriately by independent reli-able examiners. Comparisons are madewithin subjects rather than between subjectsand so the results apply only to the individ-

ing adductor tenotomy or the increase inhematocrit after transfusion. Technical out-comes are measured with laboratory instru-ments such as goniometers, rulers, and radiographs.

Functional outcomes focus on what thepatient is doing. They measure the patient’sability to perform a task to completion, andmay also measure the quality of the perfor-mance, (e.g., ease of movement, normaliza-tion of gait pattern). Functional improve-ments enhance the patient’s or the caregiv-er’s quality of life, so measures of functioncan also be measures of quality of life.

Patient satisfaction measures require that thepatient be queried not only about the out-comes as a result of the intervention or pro-cedure, but also about how that care orintervention was delivered. Patient satisfac-tion can be measured accurately.23

Lastly, measuring cost effectiveness can be adaunting but necessary task, as medicinereassesses those procedures which are rou-tinely done or those treatments routinelyadministered. The decision to intervene ornot often involves choosing betweenenhancing the health of the individual andenhancing the health of the community.This dilemma currently faces health carepayers, professionals, and legislators.

Measuring each of these may involve con-sideration of multiple factors and requireusing several independent scales. Forinstance, ease of caregiving and time dedi-cated to it are also centrally important out-comes, and caregiver responses should bepart of any measure of patient satisfaction.Cosmesis, which may constitute more thanphysical appearance, can influence affectivestate, self-esteem, and patient satisfaction.Economic issues, such as the cost of vigor-ous PT-directed stretching programs, cancome into play, and require recognition.

Syllabus A pages 1-120 4/14/98 20:52 8


K E Y P O I N T S

• Few clinical tests for spasticity havebeen validated

• The choice of test must be based onthe change expected, and the sensitivity mustmatch the rangeof expected improvement.Otherwise, theresults will be meaningless

• The potential for a positive functionaloutcome followingtreatment dependson many factorsbesides spasticity,which must alsobe accounted forby the chosen outcome measures

sures that are objective, and ideally, validat-ed and standardized with norms againstwhich patient performance can be com-pared. Non-normative data, if objective, canat the very least provide evidence of treat-ment efficacy when the patient is used as hisown control or when the outcome beingmeasured is not ordinal.

The ideal test will have a well-defined scor-ing system and known psychometric prop-erties of reliability and sensitivity to change,and be administered using standard instruc-tions.36 Unfortunately, few clinical tests forspasticity are validated in this regard. Inaddition, the tests chosen should assess awide range of tasks commonly performed indaily living, and document a continuum ofchange within each category of functionassessed. Finally, the tests must be practical,i.e., easy and timely to administer, using testequipment or materials that are affordableand available.

In assessing outcomes in the pediatric popu-lation, efficacy measures must also accountfor the influence of neural maturation andphysical growth. They must be able to dis-tinguish those changes due solely to thetherapeutic intervention from those due tonormal growth and development.

ual or subject series. While these resultscannot be generalized, generality is said tobe achieved through study replication.42

Functional effects of the intervention can bemeasured by first defining target behaviors(e.g., turning a doorknob to open the door).Where no appropriate validated measuresexist, operationally defined measures ofbehavioral response are developed. Initialpilot data collection can confirm the ade-quacy of the operational definition (e.g.,independently turning a doorknob, maneu-vering independently within the house-hold). Operational definition often requiresanalysis of the targeted behavior and select-ing some aspect of it that is most easilymeasured (e.g., volitional supination) andreliably reproduced. Table 1 outlines thesteps that may be useful in study design.

The design paradigm may follow an AB orABA design, depending on whether the aimof the study is to prove functional or techni-cal change with treatment (AB), or to provegains with treatment and then regressionwhen treatment is withdrawn (ABA).

Test Selection

To select a test that measures changes infunctional and technical values as a result oftreatment, one must first define those mea-

Define subject unit: single patient or small seriesIdentify independent variable: interventionIdentify dependent variable: expected outcome

Define target behaviorsChoose validated measure, or define measure based on expected responseSelect easily quantified relevant aspect of target behavior

Choose design paradigm: AB or ABA (withdrawal)Begin interventionCollect data: at repeated intervals, by independent examinersAssess outcome: within patient or among small series

Table 1.

Single-Subject Study Design



Measures in Spasticity Management

Clinical rating scales for spasticity have beenparticularly difficult to develop. Obstaclesencountered include not only the hetero-geneity of the affected body regions and thevariety of circumstances which can changespasticity intensity between evaluations, butalso the problem of objectively measuringtone. The intensity and distribution of spas-ticity may be affected by the time of day,training effect, emotional state of the sub-ject, or concurrent illness. Some of theseitems can be easily controlled when admin-istering outcome measures, though otherscannot.

Also, there is a poor correlation between theobserved reduction in spasticity and the

Some general principles can be statedregarding the choice of an appropriate scale.Because multiple variables contribute to out-come, assessment tools should apply tomore than just the limb or muscle in ques-tion. Further, the choice of scales must bebased on the change expected. Without this,no meaningful data can be collected on theeffectiveness of the intervention. In addition,the sensitivity range of the test shouldmatch the range of improvement expected.The results of some tests will show floor orceiling effects beyond the narrow limits oftheir sensitivity, obscuring evidence of func-tional change that may have occurred.

As discussed below, there is no one test thatis superior or measures every aspect of spas-ticity and resultant functional change withintervention. As a result, the set of outcomemeasures to be used must be selected with aspecific purpose in mind. While the use ofonly one scale may be justified in some clin-ical situations, more meaningful results willalmost always be obtained by use of severaldifferent, well-chosen scales.

Spasticity Measurement

Focal spasticity can be evaluated with elec-trodiagnostic tests. Mayer27 emphasizes thatpolyelectromyographic kinesiology tech-niques can identify electrical activity in ago-nist and antagonist muscles during attempt-ed movement. Electromyography (EMG)recordings, even simple dual channel EMG,can define those muscles which are overac-tive or inappropriately co-contracting during a desired movement. EMG can also identifywhether a target muscle is paretic (e.g.,wrist extensors in a hemiparetic arm) byanalysis of the recruitment pattern on EMG.EMG recordings that are electrically silentduring stretch may suggest contracture. Pre-and posttreatment recordings may benoticeably different from the clinical impres-sion (see Figures 1a and 1b).

EMG

Figure 1A.

Pretreatment EMG analysis during attempted wrist extensiondemonstrates pronounced co-contraction of the antagonistwrist flexors. This suggests that co-contraction, rather thanagonist (extensor) weakness, is responsible for the impair-ment in isolated wrist extension. The EMG recording of thewrist extensor activation is not shown.



improvement in function.17,21 Questionsinevitably arise: Does change in spasticitynot affect function because no effect actuallyoccurs, because the patient was inappropri-ately selected for spasticity reduction, orbecause the functional measures used areinsensitive or unreliable?

Most experienced clinicians can cite manyinstances in which reducing spasticityimproved some aspect of daily function, butonly in a task performance specific to theindividual. For example, the outcome mightbe fewer spasms disrupting sleep, or theimproved ability to use the affected arm in ahelper function like carrying firewood,washing dishes, or grooming a pet. There isan enormous variety of factors that caninfluence whether a positive functional out-come occurs as a result of spasticity treat-ment, in addition to the severity and distrib-ution of the spasticity itself. They includesuch things as the presence of sensory lossor hemi-neglect, visual impairment, posturaldyscontrol, underlying weakness, pain, inat-tention or other cognitive disability, affectivedysfunction, and early or overwhelmingfatigue. Outcome measures must accountfor those factors as well. Attempting toimprove function by treating only the spas-ticity can be futile.

Correlation Between Clinicaland Objective Measures ofSpasticity

Truly objective, technical measures of spas-ticity have been cumbersome, expensive,and limited in their applicability to the clini-cal environment. Tests such as the thresholdangle torque measurements with electrogo-niometry34 and electrophysiologic measuressuch as the H-reflex10 and VibratoryInhibitory Reflex28 have not gained anywidespread use in the clinical setting due tothese limitations. Their relevance to theactual clinical state of the patient has notbeen well demonstrated.

Recent efforts by Katz et al.20 have demon-strated some relationship between the sub-jective clinical assessment of spasticity asmeasured on the modified Ashworth scale,2

and more objective electrophysiologic andbiomechanical measures, such as the H-reflex, ramp and hold, and pendulum tests.These investigators also studied the correla-tion between these objective measures ofspasticity and measurement of motorimpairment using the Fugl-Meyer scale.13

Torque and threshold angle measures wererecorded in the upper extremity with adevice that produces passive movement ofthe elbow in a horizontal plane. (Thethreshold angle is defined as the joint angleat which torque, electromyographic, andstretch reflex activity begin to increase in aninitially silent passive muscle.) The ratio ofthe H-reflex to the M response was also col-

EMG

Figure 1B.

Here the posttreatment interference pattern of the antagonistwrist flexors is substantially reduced, following BTX injectioninto those muscles. This allows the wrist extensors (notshown) to contract without opposition.



K E Y P O I N T S

• Changes in technical mea-sures of spasticitymay not correlatewell with clinicalimprovement

• Because there is poor agreementamong clinical spasticityscales, a comprehensiveset of tests isneeded to evaluatethe effects oftreatment

lected on their group of subjects both in thearm and the leg.

Results in the upper extremity indicated thatboth the Ashworth and Fugl-Meyer scorescorrelated significantly with the ramp andhold threshold angle measurement. TheAshworth score was well correlated with theFugl-Meyer score of upper extremity motorrecovery. In the lower extremity, theAshworth score correlated well with thependulum test,3 but not with the Fugl-Meyer score. The investigators confirmedthat the objective measures they studiedwere reproducible, at least among theirstudy population of chronic hemiplegicpatients. Interestingly, they found the H/Mratio to be disappointingly variable fromsubject to subject, and no correlation wasseen with the patient’s clinical state.

Priebe et al.35 attempted to correlate resultsamong clinical scales commonly used inmeasuring spasticity in spinal cord injurypatients. Eighty-five subjects were each test-ed with a variety of clinical measures suchas the Penn spasm frequency scale30 and theAshworth score. They found poor correla-tion among the various scales, suggestingthat each scale assesses a different aspect ofspasticity in spinal cord injury. Becausethere is poor agreement among these scales,the authors recommend a comprehensiveset of spasticity assessments be used to eval-uate the effect of any treatment. Inclusion ofpatient satisfaction, global functional scales,and technological assessment are all recom-mended when pre- and post-testing apatient receiving an intervention for spastic-ity.

Measuring Patient Function andQuality of Life

Global scales of function such as the FIM orthe Barthel Index may not be sensitive tochanges in the quality of isolated move-ments, as when botulinum toxin is used todecrease excessive finger flexor spasticityand enhance grasp and release. However,timed tasks of finger and hand dexterity areappropriate when the aim of treatment is toenhance isolated movement in the arm orhand and balance the agonist/antagonistpair. Timed coordination tasks coupled withtechnical measures such as range of motion,video motion analysis,43 and Ashworth scoremay confirm a significant clinical effect.Hygiene scores, ease of caregiving scores,the Brace Wear Measure,31 or simply timingtolerance to the brace, may be more appro-priate when treatment goals are directed atimproving hygiene, pain, or splinting toler-ance. If normalization of gait pattern is thegoal, timed tests of ambulation, whichreflect the increase in cadence and speed ofwalking, are not only easy to use but arequite sensitive to change and reproducibleover serial trials.7

Quality of life measures have receivedincreasing attention in the scientific litera-ture. These models incorporate changes inhealth state and changes in quality of life,such as intolerable side effects of medica-tion. They are designed to evaluate treat-ment trade-offs, such as temporary immo-bility after tenotomy vs. improved gait afterrecovery and rehabilitation. Quality of lifedimensions can include relevant aspects ofthe disease or symptom to be studied. Theycan be designed to consider the indirectcosts or social costs of an illness or disabilitysuch as loss of job. Despite the recognitionthat the patient’s perceptions of disability orchange is important to proving the efficacyof the intervention, the quality of life mea-sures thus far developed are statisticallycumbersome37 and their validity is not cer-



Case History

C.P. is a 71-year-old right-handed white female, who suffered a right lacunar stroke with resultant left hemi-paresis 12 months earlier. At the time she presented, she was ambulating independently with a quad cane andleft ankle foot orthosis (AFO). She required set-up and minimal assistance for upper extremity (UE) bathingand dressing, and moderate assistance to don and doff her shoes and socks. She did not report pain in the UEor hand, but complained of discomfort while wearing her AFO, and she had developed a painful callus overthe navicular bone. She ambulated at the household level with her quad cane and left AFO at a slow pace, andher endurance was limited. She complained of a poor AFO fit and an abnormal gait pattern. The patientdesired improvement in the position of her left UE during gait because the excessive flexion at the elbow wasinterfering with her balance, her dressing, and her cosmesis. She also wanted a more normal gait appearance.

Clinically, she presented with a spastic hemiplegia with preserved sensation. Her examination revealed no iso-lated movement on the left. In her left UE, she had some minimal volitional movement, and 3/5 power, in flex-or synergy. She had learned to use this movement to help stabilize objects in front of her, to dress, and to graspobjects in the left hand as she manipulated them with her right. She had 3/5 power in synergy in the hip andknee, but no movement of the ankle or foot. The great toe was postured in extension (striatal toe). Spasticitywas present at rest and increased further with activity. There were minor limitations in range at the ankle, fin-gers, wrist flexors, and shoulder. Gait evaluation disclosed a tendency to plantarflex and invert within thebrace, and this limited stance time and toe-off on the left.

Discussion: This patient may benefit from botulinum toxin type A treatment. Her UE function could beimproved by weakening the involved muscles of the elbow and wrist (i.e., the elbow and wrist flexors), whileretaining the strength and control of the finger flexors. Her brace tolerance and gait might be improved byweakening the invertors and plantarflexors of the foot along with the great toe extensor (extensor hallucislongus). The treatment plan consisted of 100 U BOTOX® to the bicep and brachialis; 60 U to the flexor carpiradialis; 45 U to the flexor carpi ulnaris; and 45 U to the pronator teres, in order to improve left UE extensionwithout losing the ability to grasp with the fingers. To improve plantigrade position during stance and fit with-in the brace, 200 U BOTOX® were injected into the plantarflexors; 45 U to the extensor hallucis longus; and45 U to the invertors. Outcome measures were applied as follows:

MEASURE RATIONALE

1. Goniometry To demonstrate a technical change following BTX-A. Decreased tone allows both increased active and passive range of motion. Enhanced active range of motion may also imply improvement in strength and isolated control. Rest position is also docu-mented both before and after treatment, as BTX may modify that parameter, reflectingimproved cosmesis.

2. Ashworth Scale To demonstrate a technical change following BTX-A. Ashworth is the most universallyaccepted tone rating scale.

3. Brace Wear Measure To confirm a change in brace fit. Intolerance of her brace was a chief complaint.

4. Ambulation Speed To show a change in walking speed. One goal of treatment was to normalize gait and reduce energy expenditure.

5. Jebsen Taylor Hand To demonstrate improvement in dexterity and isolated finger movement. The patient Function Test had some functional grasp, but improper wrist position was interfering with her

ability to maximize it.

6. FIM UE Motor Score To demonstrate a change in ADL skills. Global scales are insensitive to isolated tone reduction, but one goal of treatment was to enhance function.

7. Pain Analogue Scale To demonstrate reduction in pain following BTX-A treatment. Pain reduction is an important outcome for those patients with substantial pain, and BTX-A generally will reduce pain due to tone or to poor brace fit.

8. Berg Balance Scale To demonstrate enhancement in balance following BTX-A. The patient had com-plained that the excessive flexion of the left arm was throwing off her balance in gait, and the aim of treatment was to reduce this excess flexion. Her inability to achieve normal stance time and toe-off on the paretic side further worsened her balance as well.



MEASURE RATIONALE

9. COPM To objectively measure the attainment of the patient’s own goals. The patient had identi-fied several problems in occupational performance prior to treatment. The five parame-ters most important to the patient were rank-ordered, in terms of the patient’s perceived ability to perform these functions, and in terms of their importance to her. The five parameters were dressing, grooming, functional mobility, self-esteem, and self-confi-dence. The means of the performance and satisfaction scores before and after treatment are compared. A change of 2 or more points is deemed a significant clinical change.

MEASURE PRETREATMENT POSTTREATMENT

1. AROM Wrist Extension -150° -110°Elbow Extension -60° -30°

2. PROM Wrist Extension -20° 0°Elbow Extension 0° 0°

3. Rest Postition Wrist Extension -150° -100°Elbow Extension -70° -30°

4. Ashworth Wrist Flexors 3.5 2.0Elbow Flexors 3.0 1.0

5. Brace WearMeasure Unable to Tolerate Brace Fit Proper

6. Ambulation Speed 39 sec 25 sec

7. Jebsen Hand TestWriting Unable UnableCard Turning 12 sec 7 secSmall Common Objects 25 sec 18 secSimulated Feeding 36 sec 30 secCheckers 23 sec 20 secLarge Light Object Unable UnableLarge Heavy Object Unable Unable

8. FIM UE Motor Score 8/16 12/16

9. FIM Mobility Score 10/20 13/20

10. Pain Analogue Scale 6 0

11. Berg Balance Scale 28/56 35/56

12. COPMMean performance score 1.8 5.0 Change (3.2)Mean satisfaction score 2.0 7.2 Change (5.2)

Note regarding single subject study design: Any case similar to this could be used as part of a single-subjectstudy with BTX-A. Each of the above outcome measures would be completed pretreatment and then again atappropriate intervals following treatment. Interval selection might include 2 weeks posttreatment, to assess foradverse effect and functional worsening, 4 weeks posttreatment to address the reduction in spasticity when itis theoretically at its greatest, and again at 3 and 6 months to assess the length of benefit: technically, function-ally, and in terms of patient satisfaction.



tain when applied to diverse disorders.41

Controversy exists as to whether one caneven define quality of life, let alone measureit reliably. The scales that have been validat-ed assess a wide range of health issues andare widely used. These include the SF-3637a

and the SIP. However, neither has been doc-umented to be specific in the stroke popula-tion.16 Simpler measures of patient percep-tion of disability, change, and satisfactionwith treatment effect are available but notwidely used in clinical trials (e.g., theFunction and Pain Assessment Scale1).

Patient Satisfaction and the Roleof Patient-Centered Scales

While measuring patient satisfaction is vital-ly important, it can be extremely difficult,particularly in a cognitively impaired patientor during catastrophic disease episodeswhere patient adjustment issues are impor-tant but usually uncontrollable variables.Nonetheless, attending to patient satisfac-tion offers several advantages.11 It can edu-cate clinicians to better understand thepatient’s expectations and perception of theservice received. It can provide informationregarding the patient’s use of health care ser-vices and health-related behaviors such as“doctor-shopping.” Finally, the opportunityfor a patient to provide feedback about hisperception of treatment success can enhancethe patient’s compliance with his treatmentregimen, provide an important benchmarkfor continuous quality improvement (CQI)programs, and direct attention to the deliv-ery of the service as well as to the serviceitself.

The Canadian Occupational PerformanceMeasure (COPM)33 has proved to be a veryuseful tool for tracking both functionalchanges and patient satisfaction followingspasticity treatments. Designed by theCanadian Association of OccupationalTherapists, the COPM attempts to take intoaccount the unique needs, goals, and abili-ties of the individual patient, and the envi-

ronmental and social factors that influenceobserved behavior. It is an individualizedscale that is not diagnosis-specific, andcrosses developmental stages.

The COPM assesses client outcomes in theareas of self-care, economic productivity,and leisure pursuits, using a patient-cen-tered process to identify problems in func-tional performance, define treatment goals,and assess progress. It includes a five-stepprocess based on a semi-structured inter-view with the patient or caregiver. Theprocess includes occupational performanceproblem identification; problem weightingbased on the patient’s (not the examiner’s)concerns; ranking of the five most urgentproblems; reassessment after treatment; andfollow-up to plan for further treatment ordiscontinuation of treatment.32,33 Thispatient-centered assessment and reassess-ment process provides a standardized for-mat to detect the individual’s self-perceivedchange in occupational performance prob-lems over time. The COPM is both anassessment tool and an outcome measurethat can be used in the context of a single-subject design paradigm. It has demonstrat-ed test-retest reliability and has been validat-ed for its responsiveness to change. Thus, itcan be used as a patient satisfaction measurefor randomized trials as well. It is a stan-dardized instrument in the sense that thereare specific instructions and methods foradministering and scoring the test, but it isnot a norm-referenced tool.5,24

Standards for the Use ofMeasures

In summary, validated outcome measuresshould be used wherever possible and arethe foundation of well-designed clinical tri-als. Even in office practice, certain standardsshould be adhered to in the administrationand interpretation of those measures.General standards for the use of measurehave been defined19 and are briefly summa-rized in Table 2.

K E Y P O I N T S

• The COPM is a useful measurefor tracking bothfunctionalchanges andpatient satisfaction



1. Users should be familiar with all relevant administration, scoring, and interpretation procedures

2. Users should understand the validity and reliability basis of the measure they select

3. The measure used should be relevant to the clinical situation, the population being measured, and the deci-sion-making process

4. Potential harm to the subject (either psychological or physical) should be considered and the risk-benefit ratiodetermined

5. Appropriate test conditions and procedure should be adhered to if outcome data is to be compared to pub-lished data and documented reliability, validity, and normal values

6. The sensitivity, specificity, pretest probability, and prognostic validity of the tests that categorize or diagnosethe person being tested should be considered

7. If the tests do not meet the standards used, caution and reservation regarding results should be considered

8. Measurement selection must consider practicality in terms of personnel, time, equipment, cost, space, andimpact on the subject.

Following the bibliography, a list of mea-sures is presented that have been selectedfor their relevance to measuring status andchange in patients receiving treatment forspasticity. The list is extensive but by nomeans comprehensive. Specificity and sensi-tivity in measuring technical and functionalchange relative to spasticity management isthe goal but cannot be guaranteed. Eachmeasure is categorized, briefly described,and referenced.

Table 2.

Standards For The Use of Outcome Measures

Suggested Readings forMeasurement in NeurologicalRehabilitation

1. Jones EW, Mulley GP: The measurement of spastici-ty, in Rose FC (ed): Advances in Stroke Therapy. New York, Raven Press, 1982.

2. Cole B, Finch E, Gowland C, Mayo N: Physical Rehabilitation Outcome Measures. Baltimore, Williams & Wilkins, 1995.

3. Wade DT: Measurement in Neurologic Rehabilitation. New York, Oxford Medical Publications, 1992.



1. Allergan, Irvine, CA. Function and Pain Assessment Scale. Upper Extremity Spasticity Study Following Stroke, BOTOX Study. 133-8051. 1997

2. Ashworth B: Preliminary trial of Carisprodol in multiple sclerosis. Practitioner 1964; 192:540.

3. Bajd T, Vodovnik L: Pendulum testing of spasticity. J Biomed Eng 1984; 6:9-16.

4. Barlow DH, Hersen M: Single Case Experimental Designs: Strategies for Studying Behavioral Change. Boston, Allyn & Bacon, 1995.

5. Barry MJ, Albright LA: Use of the Canadian Occupational Performance Measure for intrathecal baclofen therapy. Pediatric Phys Ther 1996; 8:183.

6. Bergner M, Bobbitt RA, Carter WB, Gilson BS: The Sickness Impact Profile: development and final revision of a health status measure. Med Care1981;19:787-805.

7. Brandstater ME, de Bruin H, Gowland C, Clark BM: Hemiplegic gait: analysis of temporal variables.Arch Phys Med Rehabil 1983; 64:583-587.

8. Campbell SK: Quantifying the effects of interven-tions for movement disorders resulting from cere-bral palsy. J Child Neurol 1996; 11 (Suppl 1):S61-70.

9. Campbell SK (ed): Physical Therapy for Children. Philadelphia, WB Saunders, 1994.

10. Delwaide PJ: Human reflex studies for under-standing the motor system. Phys Med Rehabil Clin North Am 1993; 4:669-686.

11. Elliot-Burke TL, Pothast L: Measuring patient satisfaction in an outpatient orthopedic setting, part I: key drivers and results. J Rehabil Outcomes Measurement 1997; 1:18-25.

12. Fisher WP, Fisher AG: Applications of Rasch analysis to studies in occupational therapy. Phys Med Rehabil Clin North Am 1993; 4:493-526.

13. Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S: The post-stroke hemiplegic patient. I. A method for evaluation of physical performance. Scand J Rehabil Med 1975; 7:13-31.

14. Goldberg MJ: Measuring outcomes in cerebral palsy. J Pediatr Orthop 1991; 11:682-685.

15. Gonnella C: Single-subject experimental paradigmas a clinical decision tool. Phys Ther 1989; 69:601-609.

16. Gresham G (ed): Assessment methods for patients with strokes, in Post-Stroke Rehabilitation Guidelines. Clinical Practice Guideline #16. U.S. Department of Health and Human Services, 1995,pp 33-51.

17. Haas BH, Crow JL: Towards a clinical measure-ment of spasticity? Physiotherapy 1995; 81:474-479.

18. Harvey RF, Jellinek HM: Functional performance assessment: a program approach. Arch Phys Med Rehabil 1981; 62:456-460.

19. Johnston MV, Keith RA, Hinderer SR: Measurement standard for interdisciplinary med-ical rehabilitation. Arch Phys Med Rehabil 1992; 73:s3-s23.

20. Katz RT, Rovai GP, Brait C, Rymer WZ: Objective quantification of spastic hypertonia: correlation with clinical findings. Arch Phys Med Rehabil1992; 73:339-347.

21. Katz RT, Rymer WZ: Spastic hypertonia: mecha-nisms and measurement. Arch Phys Med Rehabil1989; 70:144-155.

22. Kilgore KM, Fisher WP, Silverstein B, Harley JP, Harvey RF: Application of Rasch analysis to stu-dies in occupational therapy. Phys Med Rehabil ClinNorth Am 1981; 62:456-461.

Bibliography



23. Lavies AR, Ware JE: Involving consumers in quali-ty care assessment. Health Aff 1988; 33-48.

24. Law M, Baptiste S, Carswell A, McCall MA, Polatajko H, Pollack N: Canadian Occupational Performance Measure Test Manual. Toronto, CAOT Publications, 1994.

25. Levin HS, O'Donnell VM, Grossman RG: The Galveston Orientation and Amnesia Test. A practi-cal scale to assess cognition after head injury. J Nerv Ment Dis 1979; 167:675-684.

26. Mahoney F, Barthel D: Functional evaluation: the Barthel Index. Maryland State Med J 1965; 14:61-65.

27. Mayer NH: Functional management in spasticity after head injury. J Neuro Rehab 1991; 5:1-11.

28. Nance PW, Shears AH, Nance DM: Reflex changesinduced by clonidine in spinal cord injured patients. Paraplegic 1989; 27:296-301.

29. Ottenbacher KJ: Clinically relevant designs for rehabilitation research: the idiographic model. AmJ Phys Med Rehabil 1990; 69:286-292.

30. Penn RD, Savoy SM, Corcos DM, Latash, Gottlieb G: Intrathecal baclofen for severe spinal spasticity:a double-blind crossover study. N Engl J Med1989; 320:1517-1521.

31. Pierson SH, Katz DI, Tarsy D: Botulinum toxin A in the treatment of spasticity: functional implica-tions and patient selection. Arch Phys Med Rehabil1996; 77:717-721.

32. Pollock N: Client-centered assessment. Am J OccupTher 1993; 47:298-301.

33. Pollock N, Baptiste S, Law M, Opzoomer A, et al: Occupational performance measures: a review based on the guidelines for client-centered prac-tice of occupational therapy. Can J Occup Ther1990; 57:77-81.

34. Powers RK, Marder-Meyer J, Rymer WZ: Quantitative relations between hypertonia and stretch reflex threshold in spastic hemiparesis. Ann Neurol 1988; 23:115-124.

35. Priebe MM, Sherwood AM, Thornby JI, Kharas NF, Markowski J: Clinical assessment of spasticity in spinal cord injury: a multidimensional prob-lem. Arch Phys Med Rehabil 1996; 77:713-716.

36. Cole B, Finch E, Gowland C, Mayo N (eds): Physical Rehabilitation Outcome Measures.Baltimore, Williams & Wilkins, 1995.

37. Schwartz CE, Cole BF, Gelber RD: Measuring patient-centered outcomes in neurologic disease: extending the q-twist method. Arch Neurol 1995; 52:754-762.

37a. SF-36 Health Survey, copyright 1992 Medical Outcome Trust, 20 Park Plaza, Suite 1014, Boston, MA, 02116-4313.

38. Simpson DM: Clinical trials of botulinum toxin in the treatment of spasticity. Muscle Nerve 1997; 20 (suppl 6): S169-S175.

39. Guide for the Uniform Data Set for Medical Rehabilitation, Version 4.0 (Adult FIM). State University of New York, Buffalo. UB Foundation Activities, Inc., 1993.

40. Wade DT: Measurement and Assessment: What and Why? in Measurement in Neurological Rehabilitation. Oxford, Oxford University Press, 1992, pp 15-26.

41. Wade DT: Handicap and Quality of Life, in Measurement in Neurological Rehabilitation. Oxford, Oxford University Press, 1992, pp 89-96.

42. Whyte J: Toward a methodology for rehabilitation research. Am J Phys Med Rehabil 1994; 73:428-435.

43. Winter DA: Use of kinetic analyses in the diagnos-tics of pathological gait. Physiotherapy (Canada)1981; 209-214.


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I. TONE INTENSITY SCALES

Name: The Ashworth ScaleDescription: Ordinal scale of tone intensity0 to 4; reproducible, proven reliable only atthe elbow; patient and test condition vari-ability contribute to unreliability. TheModified Ashworth Scale described byBohannon and Smith was developed to fur-ther define the lower end of the scale, mak-ing it more discrete by adding the grade“1+”.References: Ashworth B: Preliminary trial of carisprodolin multiple sclerosis. Practitioner 1964; 192:540-542.

Lee KC, Carson L, Kinnin E, Patterson V:The ashworth scale: a reliable and repro-ducible method of measuring spasticity. JNeuro Rehab 1989; 3:205-209.

Bohannon RW, Smith MB: Interrater reliabil-ity of a modified Ashworth scale of musclespasticity. Phys Ther 1986, 67:206-207.

Name: Oswestry Scale of GradingDescription: Ordinal scale that rates stageand distribution of tone, quality of isolatedmovements. Function is addressed by a gen-eralized grade of either useful or nonusefulmovement. The scale also attempts to con-sider the influence of posture and descend-ing brainstem and spinal reflexes on tone.Reference: Goff B: Grading of spasticity and its effecton voluntary movement. Physiotherapy1976; 62: 358-361.

Name: Degree of Adductor Muscle ToneDescription: Ordinal rating of tone in aspecific muscle group (hip adductors);appropriate for patients whose treatment isaimed at reducing the adducted leg posi-tion.Reference: Snow BJ, Tsui JKC, Bhart MH, Varelas M,Hashimoto SA, Calne DB: Treatment ofspasticity with botulinum toxin: a doubleblind study. Ann Neurol 1990; 28: 512-515.

Name: Unified Parkinson's Disease RatingScale: Motor SubscaleDescription: Ordinal scale of rigidity, fingertaps, rapid alternating movements of thehands, ADLs, etc. It has five sections, alltested for reliability. The motor exam can begiven independently and scored serially toassess change after treatment.Reference: Fahn S, Elton RL, Members of the UPDRSDevelopment Committee, in Koller WC(ed): Handbook of Parkinson’s Disease. NewYork, Marcel Dekker, 1994.

Scales for Adult Patients

Measures in spasticity management Muscle & Nerve Supplement 6 1997



Name: Tardieu Scale Description: An ordinal rating of tone thatmeasures the intensity of the muscle reac-tion at specified velocities (slowest to as fastas possible). The angle at which the catch isfirst felt is also noted as a clinical estimatesimilar to the threshold angle. The threevariables are considered simultaneouslywhen assessing spasticity. Correlation withobjective measures is not known, but it hasbeen validated in reference to the Ashworthscore.References: Tardieu G, Shentoub S, Delarue R: À lad’une techique de mesure de la spasticité, inHeld JP, Pierrot-Deseilligny E (eds):Rééducation Motrice des AffectionsNeurologiques. Paris, JB Baillière et Fils,1969, pp 31-42.

Tardieu G, Rondot P, Dalloz JC, Mensch-Dechenne J, Monfraix C: The stretch reflexin man: a study of electromyography anddynamometry (strain gauge) contribution toclassification of the various types of hyper-tonus, C.P. Cerebral Palsy Bull 1959; 7: 14-17.

II. TONE/SPASM FREQUENCYSCORES

Name: Penn Spasm Frequency ScoreDescription: Ordinal rank order scale ofspasm frequency used to rate frequency ofleg spasms per hour in spinal cord spasticity.Easily scored, based on patient report ofspasm activity.Reference: Penn RD, Savoy SM, Corcos D, Latash M,Gottlieb G, et al: Intrathecal baclofen forsevere spinal spasticity. N Engl J Med 1989;320: 1517-1554.

Name: Spasm Frequency ScoreDescription: Ordinal ranking of spasm fre-quency per day, rather than per hour.Reference: Snow BJ, Tsui JKC, Bhart MH, Varelas M,Hashimoto SA, Calne DB: Treatment ofspasticity with botulinum toxin: a doubleblind study. Ann Neurol 1990; 28: 512-515.

III. GLOBAL SCALES OFMOTOR IMPAIRMENT

Name: Brunnstrom Stroke ScaleDescription: Qualitative description ofstages of motor recovery following stroke.Cumbersome and too complicated toadminister according to Wade,40 who sug-gests other simpler, more sensitive scales.Reference: Brunnstrom S: Movement Therapy inHemiplegia. New York, Harper and Row,1970.


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Name: Fugl-Meyer Evaluation of PhysicalPerformanceDescription: Quantification of motor recov-ery stages based on the scales of Brunnstromand Twitchell (ontogenetic concept of motorrecovery). In addition to motor recovery,balance, sensation, range of motion, andpain are also assessed. Movement is exam-ined in and out of synergies. The scale doesnot reflect functional use of the extremity,only motor impairment and recovery stage.This scale is commonly used in clinical trialsand requires an experienced therapist toadminister.References: Fugl-Meyer AR, Jaasko I, Leyman I, OlssomS, Steglind S: The post-stroke hemiplegicpatient I. A method for evaluation of physi-cal performance. Scand J Rehab Med 1975; 7:13-31.

Sanford J, Moreland J, Swanson LR,Stratford PW, Gowland C: Reliability of theFugl-Meyer assessment for testing motorperformance in patients following stroke.Phys Ther 1993; 73: 447-454.

Name: Rivermead Stroke AssessmentDescription: Interval scale of motor perfor-mance in post-stroke patients dealing withgross motor, leg, trunk, and arm move-ments. This scale mixes impairment mea-sures with disability measures, but has goodreliability and validity. However, it is lengthyto administer and is unwieldy for routineuse.Reference: Lincoln N, Leadbitter D: Assessment ofmotor function in stroke patients.Physiotherapy 1979; 65: 48-51.

Name: Scandinavian Stroke ScaleDescription: Ordinal scale of impairmentdivided into several subsets of recoverywhich grade strength, gait, cognition, atten-tion, and language. Items of prognostic sig-nificance are highlighted. Specific items mayor may not be sensitive to changes afterspasticity treatment.Reference: Scandinavian Stroke Study Group: Multi-center trial of hemodilution in ischemicstroke. Background and study protocol.Stroke 1985; 16: 885-890.

Name: Toronto Stroke ScaleDescription: A reliable and quick-scoringtest that primarily measures cognitive andmotor domains. Likely to be insensitive tochanges brought about by focal spasticitytreatment. It is responsive to global changeand recovery and can quantify stages ofneurologic recovery following stroke. Usefulfor stratifying patients by stage of motorrecovery or extent of motor function.Reference: Cote R, Battista RN, Wolfson C, Boucher J,Adam J, Hachinski V: The CanadianNeurological Scale: validation and reliabilityassessment. Neurology 1989; 39: 638-643.

Name: Motricity Index and Trunk ControlTestDescription: Simple short measures ofmotor loss that pertain primarily to hemi-plegia following stroke. They can be usefulfor any upper motor neuron patient. Validityand reliability are proven. Sensitive to motorchanges after CVA, although they may notbe able to detect changes after focalchemodenervation.Reference: Wade DT, Langton Hewer R: Functionalabilities after stroke: measurement, naturalhistory, and prognosis. J Neurol, NeurosurgPsychiatry 1987; 50: 177-182.




IV. UPPER EXTREMITY DEX-TERITY AND STRENGTHTESTING

Name: Grasp Dynamometer TestingDescription: Objective instrument thatmeasures grasp strength in pounds, accord-ing to the various grasps and pinches.Reference: Trombly CA, Scott AD: Evaluation and treat-ment of hand function, in OccupationalTherapy for Physical Dysfunction. Baltimore,Williams & Wilkins, 1977.

Name: Manual Muscle TestingDescription: Uses a 6-point grading systemto assess strength in muscles where thepatient has selective joint control. Strengthis rated from 0 (no contractile ability) to 5(strength through the full range of motionwith maximum resistance).Reference: Hislop HJ, Montgomery J: Daniels’ andWorthingham’s Muscle Testing: Techniques ofManual Examination, 6th edition.Philadelphia, WB Saunders, 1995.

Name: The Tufts Assessment of MotorPerformance (TAMP)Description: Evaluates fine motor skillssuch as grasp and release, use of fasteners,and object manipulation activities. It hasshown good interrater reliability. Selectedareas of the TAMP may be used to assessother aspects of activities of daily livingincluding bed mobility and wheelchairskills.Reference: Gans BM, Haley S, Hallenborg S, et al:Description and inter-observer reliability ofthe Tufts Assessment of Motor Performance.Am J Phys Med Rehab 1988, 67:202-210.

Name: The Purdue Pegboard TestDescription: A timed test of finger dexterityin two types of activity: one involving grossmovements of the hand, fingers, and arm,and a second involving fingertip dexterity asin small assembly work. Recommended as aroutine measure of dexterity. It requiresstandard prefabricated equipment to admin-ister. It has been validated and is reliable,and has been used in numerous clinical tri-als of pyramidal and extrapyramidal motordysfunction. It is portable and brief, but isuseless when impairment is severe. Reference: Tiffin J, Asher EJ: The Purdue Pegboard:norms and studies of reliability and validity.J Applied Psychol 1948; 32: 234-247.Distributed by Science Research Associates,228 S. Wabash, Chicago, IL 60641.

Name: The 9-Hole Peg TestDescription: This is a simpler and moretime-efficient measure of finger dexterity,and can be more applicable to neurological-ly involved patients. The test requires apatient to place nine pegs into a board andthen remove them individually with onehand. This a timed test for which normativedata has been obtained.References: Kellor M, Frost J, et al: Hand strength anddexterity. Am J Occup Ther 1971, 25:77-83.

Mathiowetz V, Weber K, Kashman N,Volland G. Adult norms for the nine holepeg test of finger dexterity. Occup Ther J Res1985, 5:24-38.


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Name: Jebsen Taylor Hand Function TestDescription: Timed performance of seventest items designed to represent variousaspects of hand function. It has been vali-dated and standardized and is easy to per-form in approximately 15 minutes for bothhands. Potentially sensitive to changesbrought about by spasticity treatment, butonly applicable to hands with preserved iso-lated finger control. Reference: Jebsen RH, Taylor N, Trieschemann RB, etal.: Objective and standardized test of handfunction. Arch Phys Med Rehabil 1971; 50:311-319.

Name: Frenchay Arm TestDescription: Five test items are scored in apass/fail fashion. It is valid and reliable,inexpensive, but unlikely to be useful inevaluating any but high-end performance ofupper extremity function. Sensitivity isacceptable for research, though patientstend to either completely pass or completelyfail every test item.Reference: DeSouza LH, Langton Hewer R,Miller S: Assessment of recovery of arm con-trol in hemiplegic stroke patients. Int RehabilMed 1980; 2: 3-9.

V. ADL/HYGIENE SCALES

Name: Barthel ADL IndexDescription: Subset of the Barthel Index.Best known and most widely used index.Reference: Mahoney FI, Barthel DW: Functional evalu-ation: the Barthel Index. Maryland State MedJ 1965; 14:61-65.

VI. CLINICAL GAIT SCORES

Name: Timed AmbulationDescription: Temporal distance gait mea-sure shown to be sensitive to change; validand reproducibleReference: Holden MK, Gill KM, Magliozzi MR, NathanJ, Piehl-Baker, L: Clinical gait assessment inthe neurologically impaired: reliability andmeaningfulness. Phys Ther 1984; 64:35-40.

Name: Timed Up and Go TestDescription: Multiphased timed task inwhich subject is asked to arise from a chair,walk, turn around, and sit down. It is sim-ple, responsiveness is not known, but it isreliable and has been validated and correlat-ed with performance on the Barthel Indexand Berg Balance Scale.Reference: Podsiallo D, Richardson S: The timed “upand go”: a test of basic functional mobilityfor elderly frail persons. J Am Geriatrics Soc1991; 39:142-148.

Name: Ambulation IndexDescription: Ordinal scale of ambulationdistance, speed, and level of assistanceneeded; developed for the multiple sclerosispopulation. Familiar to many neurologists.Unlikely to be sensitive to changes broughtabout by focal spasticity treatment.Reference: Hauser SL, Dawson DM, Lehrich JR, BealMF, Kevy SV, et al: Intensive immunosup-pression in progressive multiple sclerosis: arandomized, three-arm study of high doseintravenous cyclophosphamide, plasmaexchange, and ACTH. N Engl J Med 1983;308:173-180.




Name: Functional Ambulation ClassificationDescription: Nominal scale of ambulationdependence/independence grading amountof assistance necessary to ambulate. Easy toadminister, sensitive to change.Reference: Holden MK, Gill KM, Magliozzi MR, NathanJ, Piehl-Baker, L: Clinical gait assessment inthe neurologically impaired: reliability andmeaningfulness. Phys Ther 1984; 64:35-40.

Name: Berg Balance ScaleDescription: An ordinal scale of balancethat is well validated and reliable. It is sensi-tive to change and has been comprehensive-ly evaluated in stroke patients in particular.It is straightforward to administer, requiringless than 10 minutes.Reference: Berg K, Wood-Danphinee S, Williams JI,Maki B: Measuring balance in the elderly:validation of an instrument. Can J PublicHealth 1992; Jul-Aug Suppl 2:S7-11.

VII. PAIN SCALES

Name: Pain Intensity Descriptor ScaleDescription: Patient self-administered rat-ing of pain intensity; 13-point scale rangingfrom no pain to extremely intense. Reference: Gracely RH, McGrath P, Dubner R: Ratingscales of sensory and affective verbal paindescriptors. Pain 1978; 5:5-18.

Name: Function and Pain Assessment ScaleDescription: Physician and patient subjec-tive ratings of functional disability, pain fre-quency and intensity.Reference: Measurement tool in the Allergan UpperExtremity Spasticity Study Following Stroke(BTOX-133-8051).

Name: Hygiene ScoreDescription: Ordinal scale of dependenceby patient on others for perineal hygieneneeds, primarily reflecting degree of adduc-tor tone.Reference: Snow BJ, Tsui JKC, Bhart MH, Varelas M,Hashimoto SA, Calne DB: Treatment ofspasticity with botulinum toxin: a doubleblind study. Ann Neurol 1990; 28: 512-515.

Name: Brace Wear MeasureDescription: Ordinal scale that addresseswhether or not the orthotic is properly fittedor even necessary relative to the presence orabsence of spasticity. Not validated.Sensitive to changes induced by spasticitytreatment.Reference: Pierson SH, Katz DI, Tarsy D: Botulinum Atoxin in the treatment of spasticity: func-tional implications and patient screening.Arch Phys Med Rehabil 1996; 77: 717-721.

VIII. GONIOMETRY

Name: The clinical measurement of jointmotion Description: The techniques of goniometryas described in the Handbook of theAmerican Academy of Orthopedic Surgeons.Reference: Greene WB, Heckman JD (eds): The ClinicalMeasurement of Joint Motion. AmericanAcademy of Orthopaedic Surgeons.Rosemont, Illinois. 1994.


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IX. ELECTROPHYSIOLOGIC/BIOMECHANICAL MEASURES

(Note: These measurements are generallytoo cumbersome for clinical practice and arebest reserved for laboratory testing. Theirclinical correlation is not known.)

Name: Pendulum Testing of SpasticityDescription: A quantifiable evaluation ofspasticity that requires the use of an electro-goniometer and tachometer; useful in theclinical environment. Applicable to kneeand elbow measurement only.Reference: Bajd T, Vodovnik L: Pendulum testing ofspasticity. J Biomed Eng 1984; 6:9-16.

Name: Dual Channel EMG Evaluation ofInterference Patterns Description: Objective assessment of inter-ference patterns, degree of impaired motoractivity produced by paretic muscle, andtiming of co-contraction by the antagonist.References: Kraft GH: Hemiplegia: evaluation and reha-bilitation of motor control disorders. PhysMed Rehabil Clin North Am 1993; 4:687-705.

Keenan MA, Romanelli RR, Lunsford BR:The use of dynamic electromyography toevaluate motor control in the hands ofadults who have spasticity caused by braininjury. J Bone and Joint Surg 1989;71-A:120-126.

Name: H-Reflex and Hmax/Mmax RatioDescription: EMG measures of theexcitability of resting motor neurons inspasticity. Not well correlated with clinicalmeasures of spasticity such as the Ashworthscale.Reference: Delwaide PJ: Human reflex studies forunderstanding the motor system. Phys MedRehabil Clin North Am 1993; 4:669-686.

Name: Vibration Inhibitory IndexDescription: Use of vibration to inhibit theH-reflex to derive a score called theVibratory Inhibitory Index, which is a mea-sure of spasticity intensity. Reference: Nance PW, Shears AH: Reflex changesinduced by clonidine in spinal cord injuredpatients. Paraplegia 1989; 27:296-301.

X. GLOBAL SCALES OF DISABILITY

Name: Functional Independence Measure (FIM)Description: Ordinal scale of function inmultiple areas, including feeding, grooming,bathing, dressing, toileting, transfers, loco-motion, comprehension, expression, socialinteraction, and problem solving. Reference: Guide for the Uniform Data Set for MedicalRehabilitation (Adult (FIM) Version 4.0).Buffalo, New York; State University of NewYork, Buffalo/ U.B. Foundation ActivitiesInc. 1993.

Name: Barthel IndexDescription: Ordinal scale of function in 10areas similar to the FIM encompassingmobility, ADL function, continence.Reference: Mahoney FI, Barthel, DW: Functional evalu-ation: the Barthel Index. Maryland State MedJ 1965; 14:61-65.




Name: OPCS Disability ScaleDescription: Ordinal scale of 10 differentdisability measures, each weighted so thatdifferent disabilities can be compared. Thereis a pediatric version. Not well validated,but comprehensive and easy to grade.References: Martin J, Meltzer H, Elliot D: The preva-lence of disability amongst adults, in Officeof Population Census and Surveys, HMSO,London.

Wade DT: Measurement in NeurologicRehabilitation. Oxford, Oxford MedicalPublications, 1992, pp 196-205.

XI. PATIENT/CAREGIVERASSESSMENT/REPORT OFADJUSTMENT AND DISABILI-TY (“QUALITY OF LIFE” MEASURES)

Name: Sickness Impact ProfileDescription: Interval scale which is a globalmeasure of function. It gives a weightedscore to each item in 12 subsections offunction, is lengthy (30 minutes), can becompleted by the patient/caregiver or inface-to-face interview. There is no well doc-umented responsiveness to change in strokepatients. Subsections may be used alone.Reference: Bergner M, Bobbitt RA, Carter WB, GilsonBS: The Sickness Impact Profile: develop-ment and final revision of a health statusmeasure. Med Care 1981; 19:787-805.

Name: SF-36 Health SurveyDescription: 36-item patient report regard-ing patient’s perception of health and physi-cal limitations, subscores are weighted in aninterval style. It is brief and can be adminis-tered by phone, face-to-face with patient, orcompleted by patient. It does have possiblefloor effects and may not adequately mea-sure patients with severe disabilities. Allitems are standardized and it is widely usedin the U.S.Reference: SF-36 Health Survey, copyright 1992Medical Outcome Trust, 20 Park Plaza, Suite1014, Boston, MA, 02116-4313.

Name: Caregiver Dependency ScaleDescription: Patient report regarding theamount of caregiver assistance required on atypical day.Reference:Environmental Status Scale, Question 4,Minimal Record of Disability for MultipleSclerosis, p. 44; copyright 1985 NationalMultiple Sclerosis Society.

Name: Canadian Occupational PerformanceMeasureDescription: Individualized, client-centeredmeasure of three areas: self-care, productivi-ty, and leisure. The process involves patientinterview to define goals and weight them asto their urgency. Includes follow-up assess-ment after therapy or treatment is complete.Reference: Pollock N, Baptiste S, Law M, McColl MA,Opzoomer A, et al: Occupational perfor-mance measures: a review based on theguidelines for client-centered practice ofoccupational therapy. Can J Occup Ther1990; 57: 77-81.


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Name: Denver IIDescription: A revision of the DenverDevelopmental Screening Test (DDST).Can be used from ages 1 week to 6 years.Includes 125 items in four domains: person-al-social, fine motor-adaptive, language, andgross motor. Requires 25 minutes to admin-ister. It has a high sensitivity but low speci-ficity and a high over-referral rate.Reference: Glascoe FP, Byrne KE, Ashford LG, JohnsonKL, Chang B, Strickland B: Accuracy of theDenver-II in developmental screening.Pediatrics 1992; 89:1221-1225.

Name: Bayley Infant NeurodevelopmentalScreen (BINS)Description: This test has no direct rela-tionship to the Bayley Scales of InfantDevelopment. Assesses brain-behavior rela-tionships in the context of developmentalchange and maturation, in infants from 3 to24 months. Requires 15 minutes to admin-ister.Reference: Aylward GP. Bayley Infant Neurodevelopmen-tal Screen Manual. San Antonio, TX,Psychological Corporation, 1992.

Name: Harris Infant Neuromotor Test(HINT)Description: Detects early signs of cognitiveand neuromotor delays in infants withknown risk factors, from 3 to 12 months.Requires less than 30 minutes to administer.Reference: Harris SR, Daniels LE: Content validity ofthe Harris Infant Neuromotor Test. PhysTher 1996; 76(7):727-737.

I. TESTS OF MOTOR DEVEL-OPMENT AND FUNCTIONALPERFORMANCE

The following tests use motor milestone andfunctional performance to document achild’s developmental level in relation to agenorms and to document functional limita-tions that may be present.

Name: Alberta Infant Motor Scale (AIMS)Description: Assesses gross motor matura-tion. Appropriate from birth through thestage of independent walking. Composed of58 items in four physical positions: supine,prone, sitting, and standing. Requires 15minutes to administer and is noninvasive;only observation is involved.References: Piper MC, Darrah J: Motor Assessment of theDeveloping Infant. Philadelphia, WBSaunders, 1994.

Piper MC, Pinnell LE, Darrah J, Maguire T,Byrne PJ: Construction and validation of theAlbert Infant Motor Scale (AIMS). Can JPublic Health 1992; 83(Suppl 2):S46-S50.

Name: Miller First Step (Screening Test forEvaluating Preschoolers) Description: Assesses cognitive, commu-nicative, physical, social-emotional, andadaptive function; appropriate from age 2years 9 months to 6 years 2 months.Evaluates function by performance ongames using toys. Requires about 15 min-utes to administer.Reference: Miller LJ: The Miller First Step (Screening Testfor Evaluating Preschoolers). New York,Psychological Corporation, 1992.

Scales for Pediatric Patients




III. MOTOR ASSESSMENTS

Name: Test of Infant Motor Performance(TIMP)Description: Assess postural and selectivecontrol needed for functional movements inearly infancy. Can be used for prematureinfants (as young as 32 weeks postconcep-tional age), and up to age 4 months.Requires 25 to 45 minutes to administer.

References: Campbell SK, Osten ET, Kolobe THA,Fisher AG: Development of the Test ofInfant Motor Performance, in Granger CVGresham GE (eds): New Developments inFunctional Assessment. Philadelphia, WBSaunders, 1993, pp 541-550.

Developmental Motor Scales and ActivityCards. Allen, TX: DLM Teaching Resources,1983.

Name: Peabody Developmental MotorScales (PDMS) Description: Gross motor scale assessesreflexes, balance, nonlocomotion and loco-motor activities, and receipt and propulsionof objects. Fine motor scale assesses grasp,hand functions, eye-hand coordination, andmanual dexterity. For ages birth to 42months. Requires 45 to 60 minutes toadminister.Reference: Folio M, Fewell R. Peabody Hinderer KA,Richardson PK, Atwater WS: Clinical impli-cations of the Peabody DevelopmentalMotor Scales: a constructive review. PhysOccup Ther Pediatr 1989; 9(2):81-106.

II. COMPREHENSIVE DIAG-NOSTIC DEVELOPMENTALASSESSMENTS

Name: Bayley Scales of Infant Development(BSID)Description: Assesses mental functions(163 items assessing object permanence,memory, manipulation, problem solving,etc.) and both fine and gross motor function(81 items assessing hand function, posture,and locomotion). Appropriate from birth to30 months. Requires 45 to 60 minutes toadminister.Reference: Bayley N: Manual for the Bayley Scales ofInfant Development. New York, PsychologicalCorporation, 1969.

Name: Gesell Revised DevelopmentalSchedules Description: Assess adaptive motor (145items), gross motor (98 items), fine motor(56 items), and language and personal-social development (81 items). For agesbirth to 36 months. Requires about 45 min-utes to administer.Reference: Knobloch H, Stevens F, Malone AF: Manualof Developmental Diagnosis (revised edition).New York, Harper & Row, 1980.



Name: Toddler and Infant Motor Evaluation(TIME)Description: Qualitative motor assessment,including a parent interview to assess func-tional performance in dressing and otherADLs. For children ages birth to 42 months.Reference: Miller LJ: The Toddler and Infant MotorEvaluation. Tucson, AZ, CommunicationSkill Builders, 1994.

Name: Bruininks-Oseretsky Test of MotorProficiency Description: Tests gross and fine motorfunction; items stress coordination and bal-ance. For children ages 4.5 to 14.5 years.Requires 45 to 60 minutes to administer; ashort form is available.References:Bruininks RH: Bruininks-Oseretsky Test ofMotor Proficiency: Examiner’s Manual. CirclePines, MN, Americal Guidance Service,1978.

IV. ASSESSMENTS DESIGNEDFOR CHILDREN WITH DIS-ABILITIES

Name: Gross Motor Funtion Measure(GMFM)Description: Measures change over time ingross motor funtion in children with CP.Composed of 88 items in five dimensions:laying and rolling; sitting; crawling andkneeling; standing; and walking, running,and jumping. For children ages 5 months to16 years. Requires 45 to 60 minutes toadminister.References:Rosenbaum P, Cadman D, Kirpalani H.Pediatrics: Assessing quality of life, inSpilker B (ed): Quality of Life Assessment inClinical Trials. New York, Raven Press, 1990,pp 205-215.

Russell D, Rosenbaum P, Cadman D,Gowland C, Hardy S, Jarvis S: The GrossMotor Function Measure: a means to evalu-ate the effects of physical therapy. Dev MedChild Neurol 1989; 31:341-352.

Name: Pediatric Evaluation of DisabilityInventory (PEDI)Description: Detects functional limitationsand disability in age-appropriate indepen-dence. It is also a tool for program evalua-tion in tracking progress in individual chil-dren. 197 items measure functional skill inself-care, mobility, and social function. 20items assess extent of caregiver assistanceand modifications needed. Requires 20 to30 minutes to administer. References: Feldman AB, Haley SM, Coryell J:Concurrent and construct validity of thePediatric Evaluation of Disability Inventory.Phys Ther 1990; 70:602-610.

Hayley SM, Coster WJ, Faas RM: A contentvalidity study of the Pediatric Evaluation ofDisability Inventory. Pediatr Phys Ther1991;3:177-184.



Hayley SM, Coster WJ, Ludlow LH,Haltiwanger JT, Andrellos PJ: The PediatricEvaluation of Disability Inventory:Development Standardization andAdministration Manual. Boston, NewEngland Medical Center Publications, 1992.

Name: Functional Independence Measurefor Children (Wee FIM) Description: Assesses caregiver assistanceneeded to accomplish daily tasks. For chil-dren ages 6 months to 12 years. Requires 20to 30 minutes to administer.References: Granger CV, Hamilton BB, Kayton R. Guidefor the Use of the Functional IndependenceMeasure (WeeFIM) of the Uniform Data Set forMedical Rehabilitation. Buffalo, NY, ResearchFoundation, State University of New York,1989.

Msall ME, Roseberg S, DiGuadio KM, BraunSL, Duffy L, Granger CV: Pilot test for theWee FIM for children with motor impair-ments (Abstract). Dev Med Child Neurol1990; 32 (9 suppl 62):41.


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