Large Scale Clinical Audit of Functional Walking

Category and associated Clinically Meaningful

Changes for people with MS and Stroke

Tamsyn Street (MSc, PhD)

Research Aims

• To determine the effectiveness of FES in terms of walking speed, clinical meaningful changes and functional walking category for people with multiple sclerosis and stroke.

• To our knowledge these are the largest samples collected for MS and Stroke.

Participants Multiple Sclerosis

• 727 (age range 26-85, average 53) pwMS with dropped foot collected audit data between 1993 and 2013. 508 pwMS were using FES after 19 weeks with 355 complete data sets available for analysis. 85 medical records were not available due to being destroyed or lost.

Stroke

• 848 (median time post stroke: 2.3 years, range: 5 weeks to 34 years) stroke patients referred between 1993 and 2013. 502 patients completed the follow up measures after 20 weeks of treatment.

Main Outcome Measure: Speed (ms)

Effect No Stimulation Stimulation

Day 1 6 months later Day 1 6 months later

Initial Orthotic

Continuing Orthotic

Total Orthotic

Training

Clinically Meaningful Changes (Perera et al., 2006)Minimally meaningful change (>=0.05 m/s) Substantially meaningful change (>=0.1m/s)

Functional Walking CategoriesPerry et al., (1995)

Walking Category Speed (m/s)

Household walking only <0.4 m/s

Most limited community walker 0.4 to 0.58 m/s

Least limited community walking 0.59 to 0.79 m/s

Community walking >0.8 m/s

Effort of Walking and Goal Attainment

• Self-Rated Effort of Walking (Borg Scale 1-10)

Patients rate the effort of walking after each 10 metre walk using a VAS Scale from 1-10.

• Goal Attainment Scaling (GAS)

Up to 3 goals are created collaboratively between the clinician and the patient. A scale is created to enable the patient and clinician to know when the goal has been attained.

Results for Patients with MS Speed (m/s)

• All orthotic comparisons highly significant (p<0.001)

• No significant training effect as you would

expect for patients with MS.

• Clinically meaningful changes for all orthotic

comparisons (≥0.05m/s) (continuing orthotic effect (0.08ms-1)

• 97% maintained or exceeded their functional

walking category

Multiple Sclerosis Patients

>0.05 m/sminimum meaningful change

-1

-0.8

-0.6

-0.4

-0.2

0

0.2

0.4

0.6

0.8

1

0 50 100 150 200 250 300 350 400 450 500

Spe

ed

(m

/s)

Participants (n=355)

Total Orthotic Effect

Results for Stroke Patients Speed (ms)

• Highly significant initial, continuing, total and training effect (p<0.001)

• Clinically meaningful changes (≥0.05 m/s)

• Substantial meaningful change (≥0.10 m/s) for total orthotic effect (0.12 m/s).

• 96% maintained or exceeded their functional walking category

Stroke Patients

-0.8

-0.6

-0.4

-0.2

0

0.2

0.4

0.6

0.8

1

1.2

1.4

0 100 200 300 400 500 600

Spe

ed

(m

/s)

Participants (n=502)

Total Orthotic Effect

>0.05 m/sminimum meaningful change

MS: Self-Rated Effort of Walking (Borg Scale)

• A significant difference was found for self rated effort of walking (p>0.001).

0

2

4

6

8

10

12

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 59 61 63 65 67 69

Rate of Perceived Effort (RPE) Borg Scale (1-10)

Day 1 No Stimulation 20 Weeks Stimulation

CVA: Self Rated Effort of Walking

• A significant difference was found for self rated effort of walking (p>0.001).

0

1

2

3

4

5

6

7

8

9

10

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29B

org

Sca

le (

1-1

0)

Self-Rated Effort at 20 Weeks (BORG 1-10)

No Stimulation Stimulation

MS: Goal Attainment Scaling (GAS)

0 5 10 15 20 25 30 35 40

WalkingDistance

Social/Functional Activities

Effort ofWalking

Confidence

Fear of Falling

Highest Frequency Goals Selected

0

10

20

30

40

50

60

70

80

0 10 20 30 40 50 60

GA

S Sc

ore

Patients (n=56)

Goal Attainment Score (GAS): 67% achieved or exceeded goals

CVA: Goal Attainment Scaling (GAS)

0 2 4 6 8 10 12 14 16

Walking Distance

Fear of Falling

Effort of Walking

Quality of Walking

Independence

Highest Frequency Goals Selected

0

10

20

30

40

50

60

70

80

90

0 5 10 15 20 25

GAS Score (86% achieved or exceeded their goals)

Multiple Sclerosis: Fear of Falling (VAS Scale 1-10)

0

1

2

3

4

5

Prior to FES 20 Weeks with FES

Fear

of

Falli

ng:

VA

S Sc

ale

(1

-10

)

Patients (n=73)

Conclusions

Functional Electrical Stimulation Enables:

A significant increase in the speed of walking

Clinically meaningful changes in functional walking category

Effort of walking is significantly reduced

Fear of falling is significantly reduced

A greater likelihood of achieving personal goals.

Limitations

Audit Data not a Randomized Controlled Trial (RCT)

Several RCT’s have found similar findings.

Clinically relevant observational studies have several advantages over an RCT (broader range of patients, timeliness, cost).

Lack of evidence found for observational studies to be consistently larger or qualitatively different (Benson and Hartz, 2000).

Further Research

• Patient Specific measures of quality of life eg. MSIS-29

• Fear of Falling and participation using the FESI

• Salisbury FES Centre National Audit

• Quality of gait: FES compared to AFO

• Frequency of falling before and after using FES

• Work status

• Impact of FES on being a caregiver

References

• Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med. 2000;342(25):1878–86.

• Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful Change and Responsiveness in Common Physical Performance Measures in Older Adults: Meaningful Change and Performance. J Am Geriatr Soc. 2006 May;54(5):743–9.

• Perry J, Garrett M, Gronley JK, Mulroy SJ. Classification of walking handicap in the stroke population. Stroke 1995; 26: 982-989.

• Taylor, P., Humphreys, L., Swain, I., 2013. The long-term cost-effectiveness of the use of Functional Electrical Stimulation for the correction of dropped foot due to upper motor neuron lesion. J. Rehabil. Med. 45, 154–160.

• Taylor PN, Burridge JH, Dunkerley AL, Wood DE, Norton JA, Singleton C, et al. Clinical use of the Odstock dropped foot stimulator: its effect on the speed and effort of walking. Arch Phys Med Rehabil. 1999;80(12):1577–83.