Trial Outcomes & Findings for Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking and Quality of Life in MS (NCT NCT02606604)

Results Overview

Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline

Results posted on

2019-09-30

Participant Flow

PWMS were recruited from various sources from including: physician practices, physical therapy practices, support groups, web postings, email, fitness centers, and personal communication. Recruitment was from June 2015 - July 2017.

Participants were excluded from the study if they did not meet the inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	Functional Electrical Stimulation Cycling The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention.	Cycling Only The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Seven subjects completed this arm of the intervention.
Overall Study STARTED	8	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FES Cycling n=7 Participants The intervention consists of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed).	Cycling Only n=7 Participants The intervention consists of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks. Electrical stimulation will not be applied to any muscles. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=7 Participants	7 Participants n=7 Participants	11 Participants n=14 Participants
Age, Categorical >=65 years	3 Participants n=7 Participants	0 Participants n=7 Participants	3 Participants n=14 Participants
Age, Continuous	59.71 years STANDARD_DEVIATION 7.54 • n=7 Participants	47.51 years STANDARD_DEVIATION 8.97 • n=7 Participants	53.64 years STANDARD_DEVIATION 10.16 • n=14 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	5 Participants n=7 Participants	8 Participants n=14 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	2 Participants n=7 Participants	6 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 Participants n=7 Participants	7 Participants n=7 Participants	14 Participants n=14 Participants
Patient Determined Disease Steps (PPDS)	3.71 units on a scale STANDARD_DEVIATION .76 • n=7 Participants	3.71 units on a scale STANDARD_DEVIATION 1.11 • n=7 Participants	3.71 units on a scale STANDARD_DEVIATION .91 • n=14 Participants

PRIMARY outcome

Timeframe: Baseline

Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.

Outcome measures

Outcome measures
Measure	FES Cycling n=7 Participants The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.	Cycling Only n=7 Participants The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
Gait Velocity: Timed Walking	1.33 meters/second Standard Error 1.39	1.4 meters/second Standard Error 1.48

PRIMARY outcome

Timeframe: 4 weeks

Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.

Outcome measures

Outcome measures
Measure	FES Cycling n=7 Participants The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.	Cycling Only n=7 Participants The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
Gait Velocity: Timed Walking	1.34 meters/second Standard Error .18	1.42 meters/second Standard Error .18

PRIMARY outcome

Timeframe: 8 weeks

Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.

Outcome measures

Outcome measures
Measure	FES Cycling n=7 Participants The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.	Cycling Only n=7 Participants The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
Gait Velocity: Timed Walking	1.39 meters/second Standard Error .18	1.45 meters/second Standard Error .18

PRIMARY outcome

Timeframe: 12 weeks

Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.

Outcome measures

Outcome measures
Measure	FES Cycling n=7 Participants The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.	Cycling Only n=7 Participants The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
Gait Velocity: Timed Walking	1.44 meters/second Standard Error .18	1.42 meters/second Standard Error .18

SECONDARY outcome

Timeframe: Baseline

The Modified Fatigue Impact Scale is a 21 item self-report questionnaire that takes 5-10 minutes to complete. It uses a 5-point likert scale to rate the patient's perception of how Multiple Sclerosis related fatigue affects an individual's life on an everyday basis. It contains three subscales that include: cognitive, physical, and psychosocial dimensions. Scores on the subscales can be analyzed individually or as a summed score to give an overall fatigue score. Higher scores indicate a greater impact of fatigue. The minimum score is a 0 and the maximum score is 81.

Outcome measures

Outcome measures
Measure	FES Cycling n=7 Participants The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.	Cycling Only n=7 Participants The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
Self-reported Fatigue Using Modified Fatigue Impact Scale	42 score on a scale Standard Error 6.19	47.13 score on a scale Standard Error 6.19

SECONDARY outcome

Timeframe: 8 weeks

The Modified Fatigue Impact Scale is a 21 item self-report questionnaire that takes 5-10 minutes to complete. It uses a 5-point likert scale to rate the patient's perception of how Multiple Sclerosis related fatigue affects an individual's life on an everyday basis. It contains three subscales that include: cognitive, physical, and psychosocial dimensions. Scores on the subscales can be analyzed individually or as a summed score to give an overall fatigue score. Higher scores indicate a greater impact of fatigue. The minimum score is a 0 and the maximum score is 81.

Outcome measures

Outcome measures
Measure	FES Cycling n=7 Participants The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.	Cycling Only n=7 Participants The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
Self-reported Fatigue Using Modified Fatigue Impact Scale	32 score on a scale Standard Error 6.19	39.57 score on a scale Standard Error 6.19

SECONDARY outcome

Timeframe: Baseline

The Multiple Sclerosis Walking Scale is a 12-item self-report questionnaire that takes approximately 10 minutes to complete and reflects a persons' perception of the impact that multiple sclerosis has on walking ability during the past 2 weeks. Each of the items scored ranges from 1 to 5, in which higher scores indicate a greater impact of multiple sclerosis on their walking. Scores on the 12 items are summed. To transform to a 0-100 scale, the minimum score of 12 is subtracted from the sum; the result is divided by 48 and then multiplied by 100. The lowest score is 0 and the highest score is 100. Higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	FES Cycling n=7 Participants The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.	Cycling Only n=7 Participants The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale	64.43 score on a scale Standard Error 6.78	71.43 score on a scale Standard Error 6.78

SECONDARY outcome

Timeframe: 8 weeks

The Multiple Sclerosis Walking Scale is a 12-item self-report questionnaire that takes approximately 10 minutes to complete and reflects a persons' perception of the impact that multiple sclerosis has on walking ability during the past 2 weeks. Each of the items scored ranges from 1 to 5, in which higher scores indicate a greater impact of multiple sclerosis on their walking. Scores on the 12 items are summed. To transform to a 0-100 scale, the minimum score of 12 is subtracted from the sum; the result is divided by 48 and then multiplied by 100. The lowest score is 0 and the highest score is 100. Higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	FES Cycling n=7 Participants The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.	Cycling Only n=7 Participants The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale	59.91 score on a scale Standard Error 6.68	69.52 score on a scale Standard Error 6.78

SECONDARY outcome

Timeframe: Baseline

The Multiple Sclerosis Quality of Life-54 is a self-report quality of life questionnaire. It measures health-related quality of life using both generic and disease-specific measures and was constructed by experts in the field. There is no overall score for this scale since it contains 12 subscales, two summary scores, and two single-item measures. The quality of life subscale was the chosen outcome measure reported below. The scores range from 0-100. Higher scores on the scale notes improved outcome.

Outcome measures

Outcome measures
Measure	FES Cycling n=7 Participants The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.	Cycling Only n=7 Participants The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54	61.19 score on a scale Standard Error 6.28	57.62 score on a scale Standard Error 6.28

SECONDARY outcome

Timeframe: 8 weeks

The Multiple Sclerosis Quality of Life-54 is a self-report quality of life questionnaire. It measures health-related quality of life using both generic and disease-specific measures and was constructed by experts in the field. There is no overall score for this scale since it contains 12 subscales, two summary scores, and two single-item measures. The quality of life subscale was the chosen outcome measure reported below. The scores range from 0-100. Higher scores on the scale notes improved outcome.

Outcome measures

Outcome measures
Measure	FES Cycling n=7 Participants The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.	Cycling Only n=7 Participants The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54	70.95 score on a scale Standard Error 6.28	60.95 score on a scale Standard Error 6.28

Adverse Events

FES Cycling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cycling Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lori Hochman

Stony Brook University

Phone: 631-444-1193

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place