€¦ · web viewconstrained induced movement therapy sharon hakkennes1 and jennifer l keating...
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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1
NAME OF THE
CANDIDATE AND
ADDRESS (IN BLOCK
LETTERS)
RUZAL.Y.JADAV
RAJPUT STREET, JALALPORE,
NAVSARI – 396445.
GUJARAT
2 NAME OF THE
INSTITUTION
THE OXFORD COLLEGE OF
PHYSIOTHERAPY
3COURSE OF STUDY AND
SUBJECT
MASTER OF PHYSIOTHERAPY
(NEUROLOGY AND
PSYCOSOMATIC DISORDERS)
4 DATE OF ADMISSION 5TH JULY 2012
5TITLE OF THE TOPIC:
A COMPARATIVE STUDY TO FIND THE EFFECTIVENESS OF
THE MODIFIED CONSTRAINT INDUCED MOVEMENT
THERAPY (Mcimt) VERSUS MIRROR THERAPY ON HAND
FUNCTION IN STROKE PATIENTS.
6
BRIEF RESUME OF INTENDED WORK:
6.1. NEED OF THE STUDY:
Stroke or brain attack is the sudden loss of neurological function which
persists for at least 24 hours, caused by interruption of the blood flow to the
brain.1After coronary heart disease (CHD) and cancer of all types, stroke is the
third commonest cause of death worldwide.2
THE PARETIC UPPER LIMB is a common and undesirable
consequence of stroke that increases activity limitation. It has been reported
that up to 85% of stroke survivors experience hemiparesis and that 55% to 75%
of stroke survivors have continued to have limitations in upper-extremity
functioning3. The impairments of sensorimotor hand functions after a stroke
have a negative impact on the subject’s interaction with external settings and
on performing common daily and working activities and thus on the quality of
his or her life.Since the structure and function of the cerebral cortex is capable
of after stroke modifications, new therapies are being looked to support the
desirable plasticity of the central nervous system to the maximum4.
Constraint induced movement therapy (CIMT) is a family of techniques
that have been implemented to increase the amount and quality of function of
an affected upper limb. These techniques involve restraint of the intact limb
over an extended period, in combination with a large number of repetitions of
task-specific training of the affected limb5,6,7,8. constraint-induced movement
therapy is an intervention that has research support for improving motor ability
in patients suffering from a stroke by increasing the use of their affected upper
limb which is based on a theory of brain plasticity and cortical functional re-
organization.
It has 3 components:
• Repetition, structure, intense practice of the affected arm.
• Restraint of non-affected arm.
• Monitored arm use in life situations and problem solving to
overcome barriers9,10.
Signature CIMT, developed by Taub (1993) and later used in the
EXCITE trial, included restraint of the non affected upper extremity by
donning a protective safety mitt for 90% of waking hours over a two-week
intervention Period11.
However, an increased amount of practice task and longer restraint
time, Patient tolerance, mitt wearing adherence, feasibility in clinics, and
reimbursement issues have been emphasized as key weaknesses of the
signature CIMT protocol, for patients during the treatment period.
In response to these critiques, a number of “modified” versions have
arisen to address the issues presented by the signature form of CIMT9.
Protocols in which the duration of treatment, the amount of therapy, or the
constraint regimen differs from that described by Taub are referred to as
‘modified’ CIMT (Mcimt). Out of those, the present study will utilize
“TAIWAN REGIMEN”. Modified CIMT shortens both the intensive training
session of the paretic upper extremity (2hrs/d) and the restraint time of the
nonparetic upper extremity (6h/d) 12,13,14,15.
Mirror therapy is a simple, inexpensive and, most importantly, patient-
directed treatment that may improve upper-extremity function. Ramachandran
and Rogers-Ramachandran were the first to introduce the use of these visual
illusions created by a mirror for treatment of phantom limb pain3. The idea of
using mirror reflection of the uninjured hand superimposed on the injured hand
was later referred to as mirror therapy, mirror visual feedback, and mirror-
induced visual illusions16,17,18.
The underlying mechanism have mainly been related to the Activation of
‘mirror neurones’, which may also be activated when observing others perform
movements and also during mental practice of motor tasks. Mirror neurons
were found in areas of the ventral and inferior premotor cortex associated with
observation and imitation of movements and in somatosensory cortices
associated with observation of touch. The mirror neuron systems suppose to be
activated by mirror therapy16, 19.
As the studies have shown both the Mcimt and mirror therapy are
effective in improving hand function following stroke. The present study is aim
to compare the effectiveness of Mcimt and mirror therapy in stroke patients in
order to provide best clinical practice.
6.2. REVIEW OF LITERATURE:
Constrained Induced Movement Therapy
Sharon Hakkennes1 and Jennifer L Keating (2005)5 Conducted a
systemic review of randomised control trial and stated that CIMT may
improve upper limb function following stroke compared to alternative
and or no treatment.
Corwin Boake, Elizabeth A. Noser et al (2007)6 conducted a study on
Constraint-Induced Movement therapy during early stroke
Rehabilitation and concluded that Relative to the control group, the
CIMT group reported significantly greater improvement in quality of
performing daily activities using the affected hand.
Sarah Blanton and Steven L Wolf et al (1999)7 conducted study in
subacute stroke patients and concluded that Two weeks of constraining
the unaffected limb, coupled with practice of functional movements of
the impaired limb, may be an effective method for restoring motor
function within a few months after cerebral insult.
Areerat Suputtitada , Nijasri C Suwanwela et al (2004)8: conducted
a study on Effectiveness of Constraint-induced Movement Therapy in
Chronic Stroke Patients and they concluded that CIMT of unaffected
upper extremities has an advantage for chronic stroke patients which
maybe an efficacious technique of improving motor activity and
exhibiting learned nonuse.
Urška Puh et al20 conducted study on Brain Plasticity Induced by
Constraint-Induced Movement Therapy and concluded that that brain
plasticity may be modulated by specific therapeutic approaches, such as
CIMT.
Keh-chung Lin, Ya-fen Chang et al (2009)21 Effects of Constraint-
Induced Therapy (CIT) Versus Bilateral Arm Training (BAT) on Motor
Performance, Daily Functions, and Quality of Life in Stroke Survivors
BAT may uniquely improve proximal UL motor impairment. In
contrast, distributed CIT may produce greater functional gains for the
affected UL in subjects with mild to moderate chronic hemiparesis.
Ching-Yi Wu et al (2010)22 Conducted study on Brain Reorganization
after Bilateral Arm Training (BAT) and Distributed Constraint-induced
Therapy (dCIT) in Stroke Patients and found that Brain reorganization
was displayed on fMRI after BAT and dCIT in 5 of the 6 stroke
patients, but the patterns of plastic changes were patient-dependent.
Modified Constrained Induced Movement Therapy
Ching-yi Wu, ScD et al (2007)13conducted a study to find the Effects of
Modified Constraint-Induced Movement Therapy on Movement
Kinematics and Daily Function in Patients With Stroke and concluded
that Mcimt was associated with greater improvement than Traditional
Rehablitation in daily functioning but also in motor control.
Stephen J Page, Peter Levine et al (2008)14 conducted a study on
modified constrained induced movement therapy and concluded that
Mcimt-a reimbursable, outpatient protocol-increases use and function in
subjects with acute, subacute, and chronic stroke.
Yue X. Shi and Jin H. Tian et al(2011)15done a meta analysis in 2011
on Constraint-Induced Movement Therapy Versus Traditional
Rehabilitation in Patients With Upper- Extremity Dysfunction after
Stroke and concluded that Modified CIMT is a feasible alternative
intervention for patients with upper-extremity dysfunction after stroke
and can reduce the level of disability, improve the ability to use the
paretic upper extremity, and increase the use of the paretic upper limb
in daily living.
Jerzy P. Szaflarski, Stephen J. Page (2006)23 conducted a study in
2006 on Cortical Reorganization Following Modified Constraint-
Induced Movement Therapy and stated concluded that Increased
affected arm use during Mcimt appears to induce cortical
reorganization, as measured by fMRI.
Mirror Therapy
Gunes Yavuzer, Ruud Selles et al (2008)4 conducted a Randomized
Controlled Trial(2008) and concluded that In group of subacute stroke
patients, hand functioning improved more after mirror therapy in
addition to a conventional rehabilitation program compared with a
control treatment immediately after 4 weeks of treatment and at the 6-
month follow-up.
Andreas Stefan Rothgangela, Susy M. Brauna,b,c,d, Anna J.
Beurskensa et al (2011)17 done a systemic review of literature and
concluded that The work on MT needs to be considered in the context
of any new treatment modality and Future studies should try to identify
patients who might profit more by MT than others, to guide more
specific intervention through MT.
Ezendam D et al (2009)18 done a systemic review of the effectiveness
of mirror therapy in upper extremity function and concluded that mirror
therapy is effective in upper limb treatment of stroke patients and
patients with chronic regional pain syndrome.
Gi Jeong Yun et al conducted a study (2011)24 and concluded that hand
rehabilitation combined with mirror therapy and neuromuscular
electrical stimulation may be more helpful than applying individual
therapy.
Validity and Reliability of Motor Activity Log Scale
Gitendra Uswatte, Edward Taub et al (2005)25 conducted a study to
find Reliability and Validity of the Upper-Extremity Motor Activity
Log-14 for Measuring Real-World Arm Use and concluded The
participant MAL QOM scale can be used exclusively to reliably and
validly measure real-world, upper-extremity rehabilitation outcome and
functional status in chronic stroke patients with mild-to-moderate
hemiparesis.
Validity and Reliability of Action research Arm Test
C. L. Hsieh , I. P. Hsueh, F. M. Chiang, P. H. Lin (1998)26 conducted
a study Inter-rater reliability and validity of the action research arm test
in stroke patients and concluded that Intra-class correlation coefficient
(ICC) for the total score was indicating very high inter-rater reliability.
6.3. OBJECTIVES OF THE STUDY:
To find out the effectiveness of Mcimt for hand function in stroke patients.
To find out the effectiveness of Mirror Therapy for hand function in stroke patients.
To compare the effectiveness of both of them.
6.4. HYPOTHESIS:
Alternate Hypothesis: There will be a significant difference between the effectiveness of Mcimt
and Mirror Therapy on hand function in both the groups.
Null Hypothesis: There will be no significant difference between the effectiveness of
Mcimt and Mirror Therapy on hand functions in both the groups.
7.
MATERIALS AND METHODS:
7.1 STUDY DESIGN AND SETTING:
7.1.1. STUDY DESIGN : A Comparative Interventional study
7.1.2. SOURCE OF DATA:
In and around Bangalore
7.2. METHODOLOGY:
7.2.1. POPULATION:
Individuals diagnosed with stroke, fulfilling selection criteria.
7.2.2. SELECTION CRITERIA:
INCLUSION CRITERIA:
Stroke – ≥3 months. Subjects include adults with age of more than 40 years along
with a clinical diagnosis of stroke. Subjects with the ability to extend affected hand at least 10° at
the interphalangeal and metacarpophalangeal joints and 20° at wrist joint.
Mini-Mental State Examination- ≥24. Subjects having no balance problem that might risk safety. Ability to follow directions (written, verbal, or demonstration). Subjects who Lives with family caregivers at their homes.
EXCLUSION CRITERIA:
• Subjects with cognitive deficit.
• Subjects with perceptual problems.
• Subjects having voluntary motor control grading - <2.
• Subjects with any uncontrolled medical complications.
• Any upper extremity orthopaedic limitation.
7.2.3. SAMPLING METHOD AND SAMPLE SIZE:
a) Sampling Technique: Convenient Sampling.
b) Sampling Size: 20 Subjects.
7.2.4. DATA COLLECTION METHOD
Subject who fulfils the selection criteria will be included in the
study and written consent will be taken from them. Subjects will be explained
regarding the therapy to be administered.
Subjects will be randomly divided into 2 groups:
GROUPS
GROUP -1 GROUP -2Mcimt Mirror therapy
Group 1. (Mcimt Group):
Training will be administered intensively 2 hrs per day, 5 days per week, for 3
weeks. Mcimt will be given by mainly concentrating on use of affected hand
which will consist primarily of a procedure termed shaping, which involves,
1: Selecting functional task that will be tailored to address the motor deficit of
the affected hand.
2: Increasing task difficulty in small steps when performance improves on
three consecutive trials.
3: Providing immediate feedback when the task will be successfully completed
or movement speed or quality improved.
During 3 weeks of period, the affected arm will be constrained every weekday
for 6hrs identified as a time of frequent arm use.
Group 2. (Mirror Therapy) :
Therapy will be administered 2 hrs per day, 5 days per week, for 3
weeks. During the mirror practices, patients will be seated close to a table on
which a mirror will be placed vertically. The involved hand will be placed
behind the mirror and the non involved hand in front of the mirror. Thus,
seeing the reflection of the non-affected hand movement, patient will be asked
to imitate the same movement with the affected hand. Patients can see only
non-affected hand in the mirror. The practice will be consisting of functional
tasks given to the patients performing with the non-affected hand.
At the end of three weeks, the statistical analysis of the data will be
done to compare the effectiveness of the both the methods.
7.2.5. MATERIALS REQUIRED:
Splint and Sling. Mirror Box. Objects according to the functional task requirements.
7.2.6. OUTCOME MEASURES:
Motor activity log scale-14. Action Research Arm Test.
7.3. STATISTICAL ANALYSIS:
The collected data will be analyzed using the following statistical tests:
Paired t -test (for within group analysis)
Unpaired t- test (for inter group analysis)
7.4. A). Does the study require any investigation on intervention to be
conducted on patients or other humans or animals? If so please
describe briefly: YES.
B). Has ethical clearance been obtained from your institution in case of
7.4: YES (Appendix I ).
nf
REFERENCES:
1.K.aho, P.harmensen, S.Hatano.cerebrovascular disease in the
8. community:result of a world health organization collaborative study.Bulletin of
the world health organization 1980;58(1):113-130.
2. Li SC, Schoenberg BS, Wang C, et al. Cerebrovascular disease in the
People’s Republic of China: epidemiologic and clinical features. Neurology
1985; 35: 1708-13.
3. Yavuzer G, Selles R, Sezer N, et al. Mirror Therapy Improves Hand
Function in Subacute Stroke:A Randomized Controlled Trial. Arch Phys Med
Rehabil 2008;89:393-398.
4. Macháčková K, Vyskotová J, Opavský Jet al.The Impairments of
Sensorymotor Hand Functions In Stroke Patients-The Comparision of The
Results Of a Clinical Assessment And The Assessment Utilizing The Standard
Tests (A Case Study).Gymn. 2007; 37:57-67.
5. Hakkennes S, Keating J. Constraint-induced movement therapy
following stroke: A systematic review of randomized controlled trials.Australian
Journal of Physiotherapy 2005; 51:221-231.
6. Boake C, Noser E , Ro T et al “Constraint- Induced Movement
Therapy During Early Stroke Rehabilitation” Neurorehabilitation and Neural
Repair 2007; 21:14-24.
7. Blanton S,Wolf S. An Application of Upper-Extremity Constraint-
Induced Movement Therapy in a Patient With Subacute StrokePhysical Therapy
2012;79:847-853.
8.Suputtitada A, Suwanwela N,Tumvitee S et al Effectiveness of
Constraint-induced Movement Therapy in Chronic Stroke Patients. J Med Assoc
Thai 2004; 87:1482-1490.
9. Taub E,Uswatte G,Pidikiti R. et al. Constraint-induced movement
therapy: a new family of techniques with broad application to
physicalrehabilitation –a clinical review+. Journal of Rehabilitation Res Dev.
1999; 36:237-251.
10. Bonifer N and Anderson K. Application of Constraint-Induced
Movement Therapy for an Individual With Severe Chronic Upper-Extremity
Hemiplegia. PHYS THER. 2003; 83:384-398.
11. Department of Rehabilitation Medicine. Constraint-InducedMovement
Therapy (CIMT): Current Perspectives and Future Directions. USA:Aimee P.
Reiss 2012.
12.Wu C, Lin K,Chen H et al Effects of Modified Constraint-Induced
Movement Therapy on Movement Kinematics and Daily Function in Patients
With Stroke:A Kinematic Study of Motor Control Mechanisms.
Neurorehabilitation and Neural Repair 2007;21(5):460-466.
13. Wu c, Lin K, Chen Ket al. Effects of Modified Constraint-Induced
Movement Therapy on Movement Kinematics and Daily Function in Patients
With Stroke:A Kinematic Study of Motor
Control.Mechanisms.Neurorehabilitation and Neural Repair 2007; 21:628-638.
14. Page S, Levine P, Leonard A, Jerzy P et al. Modified Constraint-Induced
Therapy in Chronic Stroke: Results of a Single-Blinded Randomized Controlled
Trial. PHYS THER. 2008; 88:333-340.
15. Yue X. Shi,Jin H. Tian, Ke H. Yang, Yue Zhao. Modified Constraint-
Induced Movement Therapy Versus Traditional Rehabilitation in Patients With
Upper-Extremity Dysfunction After Stroke: A Systematic Review and Meta-
Analysis. Arch Phys Med Rehabil Vol 92, June 2011.
16. Matthys K, Smits M, Geest J,. Mirror-Induced Visual Illusion of Hand
Movements:AFunctional Magnetic Resonance Imaging Study. Arch Phys Med
Rehabil 2009;90:675-681.
17. Rothgangela A, Brauna S, Beurskensa A et alThe clinical aspects of
mirror therapy in rehabilitation:a systematic review of the literature.
International Journal of Rehabilitation Research 2011; 34: 1-13.
18. Ezendam D, Bongers RM, Jannink MJ. Systematic review of the
effectiveness of mirror therapy in upper extremity function Disability
Rehabilitation, 2009; 20:1-15.
19. Rothgangela A, Brauna S, Beurskensa A et al. The clinical aspects of
mirror therapy in rehabilitation: a systematic review of the literature.
International Journal of Rehabilitation Research 2011; 34: 1-13.
20. Puh U.Brain Plasticity Induced by Constraint-Induced Movement
Therapy: Relationship of fMRI and Movement Characteristics. University of
Ljubljana;131-148.
21. Lin K, Chang Y, Wu C et al. Effects of Constraint-Induced Therapy
Versus Bilateral Arm Training on Motor Performance, Daily Functions, and
Quality of Life in Stroke Survivors. Neurorehabilitation and Neural Repair
2009; 23: 441-448.
22. Wu C, Hsieh Y, Lin K et al. Brain Reorganization after Bilateral Arm
Training and Distributed Constraint-induced Therapy in Stroke Patients: A
Preliminary Functional Magnetic Resonance Imaging Study.Chang Gung Med J
2010;33:628-38.
23. Szaflarski J, Page S, Kissela B et al. Cortical Reorganization Following
Modified Constraint-Induced Movement Therapy: A Study of 4 Patients With
Chronic Stroke. Arch Phys Med Rehablitation 2006; 87:1052-1058.
24. GJ Y,MH C, JY P et al. The synergic effects of mirror therapy and
neuromuscular electrical stimulation for hand function in stroke patients. Ann
Rehabil Med . 2011 ;35(3):316-21.
25. Uswatte G, Taub E, Morris D et al .Reliability and Validity of the
Upper-Extremity Motor Activity Log-14 for Measuring Real-World Arm
Use.Stroke. 2005;36: 2493-2496.
26. Hsieh C, Hsueh I, Chiang F,P et al. Inter-rater reliability and validity of
the action research arm test in stroke patients.Age Ageing 1998;27: 107-113.
9. Signature of the Candidate
10. Remarks of the Guide
11.
NAME AND DESIGNATION OF THE GUIDE11.1 Guide Mr.SUBRAMANIAN
(Assistant professor)
11.2. Signature
11.3. Head of the Deparment MR.R.VASANTHAN (MPT)
11.4. Signature
12.
12.1. Remarks of Chairman and Principal
12.2. Signature
MR.R.VASANTHAN (MPT)
APPENDIX- I
THE OXFORD COLLEGE OF PHYSIOTHERAPY,
NO 6/9, 1ST CROSS, BEGUR ROAD, HONGASANDRA, BANGALORE: 560068
Review Board on Ethics for Research
Review Category: Exemption from Review Expedited Review Full Review
We hereby declare that the project titled “A COMPARATIVE STUDY TO FIND THE
EFFECTIVENESS OF THE MODIFIED CONSTRAINT INDUCED MOVEMENT
THERAPY (Mcimt) VERSUS MIRROR THERAPY ON HAND FUNCTION IN
STROKE PATIENTS” carried out by MS. RUZAL JADAV of 1st Year M.P.T. has been
brought forward for scrutiny to the board members.
Involvement of Special groups: NO
Type of Study: A Comparative Experimental Study.
AV Needs: YES
After analyzing the objectives, subjects involved and the methodology of the study, the
following conclusions were drawn. The study does not cause any mental or physical harm to
the subjects involved and there are no risks involved in the study. The board has evaluated
and confirmed that the experimenter is trained and qualified in measuring outcome. The
informed consent form ensures that the experimenter explains the procedure of the study to
the subjects, their voluntary participations is confirmed and the identification of subjects is
maintained confidential.
More over the finding of the study will benefit the profession and the society. Hence
the review board has no objections on the conduct of the study.
Chairman Vice Chairman
Date:
APPENDIX-II
ETHICAL CONSENT FORM
I, the undersigned, have fully understood that
Mr/Miss/
Mrs……………………………………………………………………………………………
…………………… is being a subject for undertaking the scientific study titled “A
COMPARATIVE STUDY TO FIND THE EFFECTIVENESS OF THE MODIFIED
CONSTRAINT INDUCED MOVEMENT THERAPY (Mcimt) VERSUS MIRROR
THERAPY ON HAND FUNCTION IN STROKE PATIENTS”
I have been made aware of the purpose for this study. I understand that I have to
co-operate with the researcher for this study and a copy of the consent form has been given to
me for my reference.
Date: Permission of the subject
Place:
APPENDIX-III
CONSENT FORM
TITLE:
“A COMPARATIVE STUDY TO FIND THE EFFECTIVENESS OF THE MODIFIED
CONSTRAINT INDUCED MOVEMENT THERAPY (Mcimt) VERSUS MIRROR
THERAPY ON HAND FUNCTION IN STROKE PATIENTS”
INVESTIGATOR: Ms. RUZAL .Y JADAV. (post graduate student)
Contact Detail of Principal Investigator:
Chairman IEC No. 6/9, 1st cross, Hongasandra, Begur main road,
Bangalore - 68.
Phone: 080-30219842.
SUBJECT’S CONSENT:
I Mr/ Miss/ Mrs. ……………………. agree to participate in the study. I have
understood the procedure of the study as explained to me by the investigator of the study.
This study will help the health care professionals to know about the public awareness of
physiotherapy and helped them to know about physiotherapy.
PURPOSE OF THE RESEARCH:
I have been informed by Ms.RUZAL JADAV . is going to do an Interventional study to find
out the effectiveness of Mcimt and Mirror therapy on hand function in Stroke patients ,
which therapy is giving better improvement to the subjects. The purpose of the current study
is also to provide a better cilinical practice to the physiotherapists in an order to get better
results.
PROCEDURE:
I have been explained that this study is conducted by using Mcimt and Mirror Therapy as
intervention and the results will be obtained through Motor Activity Log Scale-14 scale and
action research arm test. The study involves 20 participants.
RISK AND DISCOMFORT:
I know there are no risks involved in participating in the study if I feel any discomfort during
intervention period Ms. RUZAL JADAV. will take appropriate care to safeguard the welfare
and best interests of the subjects.
BENEFITS:
This study will give better information to the physiotherapist about the effectiveness of
Mcimt and Mirror Therapy on hand function in stroke patients and will help to suggest which
therapy is more effective and may help the community. This study will not provide any direct
benefit to me.
CONFIDENTIALITY:
I understand that the medical information produced by this study will be confidential. Apart
from the investigator no one will ever access to the data without my consent. If the data are
used for the publication in the medical literature or for teaching purpose no name will be
used.
PHOTOGRAPHY CONSENT DOCUMENT:
I………….. Have been explained by Ms. RUZAL JADAV. that photograph are
required in order to illustrate various aspect of the study for the thesis and other article, and at
presentation and conference. These images may also be converted to electronic format for use
in multimedia presentation and document accessible to other by computer for the purpose of
sharing the result of the study and for promoting this research. By giving my consent I
authorize her to use any of the photographs taken in printed format, in slides for presentation,
and in electronic format. If the photograph is use the face will be taped to prevent
identification.
REQUEST FOR MORE INFORMATION:
I understand that I am encouraged to discuss any concerns regarding this study at any
time. Ms. RUZAL JADAV. is available to answer my question to the best of her knowledge.
A copy of this consent form will be given to me for my careful reading.
REFUSAL OR WITHDRAWAL OF PARTICIPATION:
I understand that my participation is voluntary and I may withdraw consent and
discontinue participation any time without fear of prejudice. My decision whether or not to
participate will not affect relationship with any agency, heath care provider, etc. I also
understand that she may terminate my participation in the study after she has explained the
reason for doing so.
NON COMMERCIALIZATION:
The data collected will not be distributed for monetary benefit.
INJURY STATEMENT:
I understand that in the unlikely event of injury resulting directly from the participation
in the study, medical treatment would be available, but no further compensation will be
provided. I understand my agreement to participate in the study and I am not waiving any of
the legal rights for the same. I have explained to Mr./ Ms.…………………..the purpose of
the research, the procedures required and possible risks and benefits associated, to the best of
my ability.
Investigator: Date:
I confirm that Ms. RUZAL JADAV has explained me the purpose of this research, the study
procedure and the possible risks and benefits associated that I may experience. I have read
and understood this consent form to let myself participate as a subject in this research project
and I am giving the consent willfully.
Subject: Date:
SIGNATURE OF WITNESS:
APPENDIX-IV
Patient Assessment Proforma:
DEMOGRAPHIC DETAILS
Name:Age:Gender:Occupation:Address:IPD No:Opd No:Handedness:
Chief Complaints of patient:
History:
Vitals:BP:HR:RR:
ON OBSERVATION:General body built:Posture:Attitude of the limb:Oedema:
ON PALPATION:Tone:Tenderness:Odema:
EXAMINATION:Higher Mental Functions : Level of Conciousness- Orientation- Attention- Memory- Communication- Emotional Status-
Higher Cortical Functions: Cognition - Mini Mental State Examination Perception –
Cranial Nerve Examination:
Sensory Examination: Suprficial - Deep - Cortical -
Motor Examination: a)Tone- b)Voluntary Control Grading – c)Reflexes- d)Coordination Examination - e)Balance Examination – f)Gait-
Functional Status Examination:
HAND ASSESMENT:Grips Testing: Power Grip : Cylindrical Grip - Spherical Grip - Hook Grip - Lateral Prehension -
Precision Grip : Pad-to-Pad Prehension - Tip-to-Tip Prehension - Pad-to-Side Prehension -
Functinal Task Assessment:
Preintervention:
1).Motor Activity Log Scale-14 SCORE-2).Action research Arm test- SCORE-
Postintervention:
1).Motor Activity Log Scale -14 SCORE-2).Action research Arm test- SCORE-
APPENDIX-VProvided by the Internet Stroke Center — www.strokecenter.org
MINI-MENTAL STATE EXAMINATION (MMSE)
Patient Name: ___________________________Rater Name: ___________________________Date: ___________________________Activity Score
ORIENTATION – one point for each answerAsk: “What is the: (year)(season)(date)(day)(month)?” ____Ask: “Where are we: (state)(county)(town)(hospital)(floor)?” ____
REGISTRATION – score 1,2,3 points according to how many are repeatedName three objects: Give the patient one second to say each.Ask the patient to: repeat all three after you have said them.Repeat them until the patient learns all three. ____
ATTENTION AND CALCULATION – one point for each correct subtractionAsk the patient to: begin from 100 and count backwards by 7.Stop after 5 answers. (93, 86, 79, 72, 65) ____
RECALL – one point for each correct answerAsk the patient to: name the three objects from above. ____
LANGUAGEAsk the patient to: identify and name a pencil and a watch. (2 points) ____Ask the patient to: repeat the phrase “No ifs, ands, or buts.” (1 point) ____Ask the patient to: “Take a paper in your right hand, fold it in half,and put it on the floor “ (1 point for each task completed properly) ____Ask the patient to: read and obey the following: “Close your eyes.” (1 point) ____Ask the patient to: write a sentence. (1 point) ____Ask the patient to: copy a complex diagram of two interlocking pentagons. (1 point) ____
TOTAL : ____
APPENDIX-VI
Berg Balance Scale
Name: __________________________________ Date: ___________________
Location: ________________________________ Rater: ___________________
ITEM DESCRIPTION SCORE (0-4)
Sitting to standing ________Standing unsupported ________Sitting unsupported ________Standing to sitting ________Transfers ________Standing with eyes closed ________Standing with feet together ________Reaching forward with outstretched arm ________Retrieving object from floor ________Turning to look behind ________Turning 360 degrees ________Placing alternate foot on stool ________Standing with one foot in front ________Standing on one foot ________
Total: ________
APPENDIX-VII
Motor Activity Log-14
TABLE I. Motor Activity Log (MAL) Items
1. Hold book2. Use towel3. Pick up glass4. Brush teeth5. Shave/Make-up6. Open door with key7. Write/Type8. Steady self9. Put arm through clothing10. Carry object11. Grasp fork/spoon12. Comb hair13. Pick up cup14. Button clothes
TABLE II. Motor Activity Log (MAL) Scales
Quality of Movement (QOM)0 The weaker arm was not used at all for that activity (never)1 The weaker arm was moved during that activity but was
not helpful (very poor)2 The weaker arm was of some use during that activity but
needed help from the stronger arm or moved very slowly or with difficulty (poor)
3 The weaker arm was used for the purpose indicated but movements were slow or were made with only some effort
(fair)4 The movements made by the weaker arm were almost
normal, but were not quite as fast or accurate as normal (almost normal)
5 The ability to use the weaker arm for that activity was as good as before the stroke (normal)
Amount of Use (AOU)0 Did not use weaker arm (never)1 Occasionally used weaker arm, but only very rarely (very
rarely)2 Sometimes used weaker arm but did the activity most of
Quality of Movement (QOM)the time with stronger arm (rarely)
3 Used weaker arm about half as much as before the stroke (half pre-stroke)
4 Used weaker arm almost as much as before the stroke (3/4 pre-stroke)
5 Used weaker arm as often as before the stroke (same as pre-stroke)
SCORE:
1. QOM:
2. AOU:
APPENDIX-VIII
ACTION Patient Name: ____________________________RESEARCH Rater Name: ____________________________ARM TEST Date: ____________________________
InstructionsThere are four subtests: Grasp, Grip, Pinch, Gross Movement. Items in each are ordered so that:if the subject passes the first, no more need to be administered and he scores top marks for that subtest;if the subject fails the first and fails the second, he scores zero, and again no more tests need to be
performed in that subtest;otherwise he needs to complete all tasks within the subtestActivity ScoreGrasp1. Block, wood, 10 cm cube (If score = 3, total = 18 and to Grip) _______Pick up a 10 cm block2. Block, wood, 2.5 cm cube (If score = 0, total = 0 and go to Grip) _______Pick up 2.5 cm block3. Block, wood, 5 cm cube _______4. Block, wood, 7.5 cm cube _______5. Ball (Cricket), 7.5 cm diameter _______6. Stone 10 x 2.5 x 1 cm _______Coefficient of reproducibility = 0.98Coefficient of scalability = 0.94
Grip1. Pour water from glass to glass (If score = 3, total = 12, and go to Pinch) _______2. Tube 2.25 cm (If score = 0, total = 0 and go to Pinch) _______3. Tube 1 x 16 cm _______4. Washer (3.5 cm diameter) over bolt _______Coefficient of reproducibility = 0.99Coefficient of scalability = 0.98
Pinch1. Ball bearing, 6 mm, 3rd finger and thumb (If score = 3, total = 18 and go to Grossmt) _______2. Marble, 1.5 cm, index finger and thumb (If score = 0, total = 0 and go to Grossmt) _______3. Ball bearing 2nd finger and thumb _______4. Ball bearing 1st finger and thumb _______5. Marble 3rd finger and thumb _______6. Marble 2nd finger and thumb _______Coefficient of reproducibility = 0.99Coefficient of scalability = 0.98_________ __________________________________________________
Grossmt (Gross Movement)1. Place hand behind head (If score = 3, total = 9 and finish) _______2. (If score = 0, total = 0 and finish _______3. Place hand on top of head _______4. Hand to mouth _______
Coefficient of reproducibility = 0.98Coefficient of scalability = 0.97