Trial Outcomes & Findings for FES-Rowing: Preventing the Secondary Conditions of Paralysis Through Vigorous Exercise (NCT NCT05144113)

Last Updated: 2024-07-08

Results Overview

measures barriers to physical activity across the intrapersonal (health and beliefs/attitudes) and interpersonal (friends and family) domains. Minimum score is 0 (not a barrier at all), and larger scores up to a maximum domain score of 5 indicate bigger barriers to physical activity.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

baseline

Results posted on

2024-07-08

Participant Flow

Outpatient department of Rehabilitation Hospital

Participant milestones

Participant milestones
Measure	Current FES-Row Subjects To determine user needs we will survey 10 subjects that are currently participating in FES-row training to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and FES-rowing. Survey subjects to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and FES-rowing.: The following questionnaires will be answered by subjects: Questionnaires: Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI): measures barriers to physical activity across the intrapersonal, interpersonal, organizational, and community domains. Physical Activity and Disability Survey (PADS): measures physical activity for people with chronic neurological conditions. Demographic and Mobility Questionnaire: Important information to inform on user and design needs and potential market for at home FES-row system. Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)-(FES-row participants only): measures satisfaction with current FES-row system used in the ExPD Program.	Non-FES-Row Subjects To determine user needs we will survey 10 subjects that have never participated in FES-row training to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and FES-rowing. Survey subjects to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and FES-rowing.: The following questionnaires will be answered by subjects: Questionnaires: Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI): measures barriers to physical activity across the intrapersonal, interpersonal, organizational, and community domains. Physical Activity and Disability Survey (PADS): measures physical activity for people with chronic neurological conditions. Demographic and Mobility Questionnaire: Important information to inform on user and design needs and potential market for at home FES-row system. Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)-(FES-row participants only): measures satisfaction with current FES-row system used in the ExPD Program.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	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-row Training n=10 Participants 10 subjects, male and female, 18 years and older with lower limb paralysis who use a wheelchair as their primary means of mobility and are currently participating in FES-row training	Non-FES-row Training n=10 Participants 10 subjects, male and female, 18 years and older with lower limb paralysis who use a wheelchair as their primary means of mobility and are not currently participating in FES-row training	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=10 Participants	9 Participants n=10 Participants	18 Participants n=20 Participants
Age, Categorical >=65 years	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants
Age, Continuous	45.8 years STANDARD_DEVIATION 17.0 • n=10 Participants	43.1 years STANDARD_DEVIATION 13.7 • n=10 Participants	44.5 years STANDARD_DEVIATION 15.1 • n=20 Participants
Sex: Female, Male Female	1 Participants n=10 Participants	3 Participants n=10 Participants	4 Participants n=20 Participants
Sex: Female, Male Male	9 Participants n=10 Participants	7 Participants n=10 Participants	16 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	10 participants n=10 Participants	20 participants n=20 Participants

PRIMARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Current FES-Row Subjects n=10 Participants Subjects who were currently training with functional electrical stimulation (FES) rowing.	Non FES-Row Subjects n=10 Participants Subjects who were not a part of the functional electrical stimulation (FES) row training program.
Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI) Intrapersonal Domain: Health	0.66 units on a scale Standard Error 0.18	1.24 units on a scale Standard Error 0.20
Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI) Intrapersonal Domain: Beliefs/Attitudes	0.22 units on a scale Standard Error 0.13	0.06 units on a scale Standard Error 0.05
Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI) Interpersonal Domain: Friends	0.83 units on a scale Standard Error 0.18	1.56 units on a scale Standard Error 0.44
Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI) Interpersonal Domain: Family	0.96 units on a scale Standard Error 0.27	1.35 units on a scale Standard Error 0.49

PRIMARY outcome

Timeframe: baseline

Population: Two subjects in the Current FES-Row group did not complete the BPAD-S and were therefore excluded from analysis (n=8 FES-Row, n=10 non FES-Row).

measures barriers to physical activity for people with chronic neurological conditions by asking each subject to endorse/deny (i.e., yes/no) experiencing 19 unique barriers. Number of subject endorsements ("yes") of each barrier per group (Current FES-Row vs. Non FES-Row) are reported. Thus, the sum of the rows will not equal the number of participants analyzed, since subject could endorse experiencing up to 19 barriers.

Outcome measures

Outcome measures
Measure	Current FES-Row Subjects n=8 Participants Subjects who were currently training with functional electrical stimulation (FES) rowing.	Non FES-Row Subjects n=10 Participants Subjects who were not a part of the functional electrical stimulation (FES) row training program.
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: cost of exercise program	5 Participants	3 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: lack of transportation	2 Participants	3 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: lack of time	4 Participants	2 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: lack of interest	1 Participants	0 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: lack of energy	2 Participants	3 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: lack of motivation	2 Participants	2 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: lack of support from friends or family to exercise	1 Participants	0 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: lack of personal care attendant who will help me exercise	3 Participants	1 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: lack of accessible facility	3 Participants	4 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: exercise is boring or monotonous	0 Participants	1 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: exercise will not improve my condition	0 Participants	1 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: exercise will make my condition worse	0 Participants	1 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: exercising is too difficult	0 Participants	1 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: don't know how to exercise	1 Participants	2 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: don't know where to exercise	1 Participants	3 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: health concerns prevent me from exercising	2 Participants	3 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: pain prevents me from exercising	3 Participants	4 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: I am too old to exercise	0 Participants	0 Participants
Barriers to Physical Activity and Disability Survey (BPAD-S) Barrier: feel uncomfortable or self-conscious in a fitness center	2 Participants	0 Participants

PRIMARY outcome

Timeframe: baseline

important information to inform on user and design needs and potential market for at home FES-row system.

Outcome measures

Outcome measures
Measure	Current FES-Row Subjects n=10 Participants Subjects who were currently training with functional electrical stimulation (FES) rowing.	Non FES-Row Subjects n=10 Participants Subjects who were not a part of the functional electrical stimulation (FES) row training program.
Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis Cerebral palsy	0 Participants	1 Participants
Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis Multiple schlerosis	1 Participants	3 Participants
Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis Spinal cord injury	9 Participants	5 Participants
Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis Spina bifida	0 Participants	1 Participants

PRIMARY outcome

Timeframe: baseline

important information to inform on user and design needs and potential market for at home FES-row system.

Outcome measures

Outcome measures
Measure	Current FES-Row Subjects n=10 Participants Subjects who were currently training with functional electrical stimulation (FES) rowing.	Non FES-Row Subjects n=10 Participants Subjects who were not a part of the functional electrical stimulation (FES) row training program.
Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used Manual wheelchair	7 Participants	8 Participants
Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used Power wheelchair	3 Participants	2 Participants

PRIMARY outcome

Timeframe: baseline

Population: Only subjects who were currently training with functional electrical stimulation (FES) rowing.

(FES-row participants only): measures satisfaction with current FES-row system used in the ExPD Program. Minimum score is 0 (least satisfied), maximum score is 5 (most satisfied).

Outcome measures

Outcome measures
Measure	Current FES-Row Subjects n=10 Participants Subjects who were currently training with functional electrical stimulation (FES) rowing.	Non FES-Row Subjects Subjects who were not a part of the functional electrical stimulation (FES) row training program.
Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST 2.0)	4.45 score on scale Standard Error 0.16	—

Adverse Events

Current FES-Row Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-FES-Row Subjects

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

Dr. J.Andrew Taylor

Spaulding Rehabilitation Hospital

Phone: 616-758-5503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place