Paralysis, Legs
Conditions
Brief summary
Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg exercise, resulting in the benefits of large muscle mass exercise. Despite the success of the FES-rowing Program at Spaulding, FES-rowing systems have not yet evolved beyond research prototypes, and ours is the only program in the US where FES-rowing is available. A new design is critically needed to enable people with paralysis to participate in FES rowing in their own homes, which we believe will maximize both the health and commercial impacts of FES-rowing.
Detailed description
The purpose of this observational study is to gain insights into user needs, and market perception of physical activity and FES-rowing to further develop a new, home-based FES-rowing system that meets the needs of people with paralysis. We will enroll a total of 20 subjects, male and female, 18 years and older with lower-limb paralysis who use a wheelchair as their primary means of mobility. Ten subjects will be current FES-rowing participants (especially those doing FES-rowing at home) and 10 subjects will be non-participants. To determine user needs we will survey prospective customers to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and FES-rowing. Questionnaires: Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI): measures barriers to physical activity across the intrapersonal and interpersonal 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.
Interventions
BEHAVIORALSurvey 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 and interpersonal 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Spaulding Rehabilitation Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male and female, * 18 years of age and older * lower-limb paralysis who use a wheelchair as their primary means of mobility.
Exclusion criteria
* Under 18 years of age * no lower-limb paralysis * People who do not use a wheelchair as their primary means of mobility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI) | baseline | 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. |
| Barriers to Physical Activity and Disability Survey (BPAD-S) | baseline | 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. |
| Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis | baseline | important information to inform on user and design needs and potential market for at home FES-row system. |
| Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used | baseline | 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) | baseline | (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). |
Countries
United States
Participant flow
Recruitment details
Outpatient department of Rehabilitation Hospital
Participants by arm
| Arm | Count |
|---|---|
| FES-row Training 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 | 10 |
| Non-FES-row Training 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 | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Non-FES-row Training | Total | FES-row Training |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 18 Participants | 9 Participants |
| Age, Continuous | 43.1 years STANDARD_DEVIATION 13.7 | 44.5 years STANDARD_DEVIATION 15.1 | 45.8 years STANDARD_DEVIATION 17 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Barriers to Physical Activity and Disability Survey (BPAD-S)
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.
Time frame: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: exercise is boring or monotonous | 0 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of energy | 2 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: exercise will not improve my condition | 0 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of transportation | 2 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: exercise will make my condition worse | 0 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of motivation | 2 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: exercising is too difficult | 0 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of time | 4 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: don't know how to exercise | 1 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of support from friends or family to exercise | 1 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: don't know where to exercise | 1 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: health concerns prevent me from exercising | 2 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of personal care attendant who will help me exercise | 3 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: pain prevents me from exercising | 3 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of interest | 1 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: I am too old to exercise | 0 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of accessible facility | 3 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: feel uncomfortable or self-conscious in a fitness center | 2 Participants |
| Current FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: cost of exercise program | 5 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: feel uncomfortable or self-conscious in a fitness center | 0 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of transportation | 3 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of time | 2 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of interest | 0 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of energy | 3 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of motivation | 2 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of support from friends or family to exercise | 0 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of personal care attendant who will help me exercise | 1 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: lack of accessible facility | 4 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: exercise is boring or monotonous | 1 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: exercise will not improve my condition | 1 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: exercise will make my condition worse | 1 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: exercising is too difficult | 1 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: don't know how to exercise | 2 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: don't know where to exercise | 3 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: health concerns prevent me from exercising | 3 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: pain prevents me from exercising | 4 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: I am too old to exercise | 0 Participants |
| Non FES-Row Subjects | Barriers to Physical Activity and Disability Survey (BPAD-S) | Barrier: cost of exercise program | 3 Participants |
Primary
Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI)
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.
Time frame: baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Current FES-Row Subjects | 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 |
| Current FES-Row Subjects | 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 |
| Current FES-Row Subjects | 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 |
| Current FES-Row Subjects | 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 |
| Non FES-Row Subjects | Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI) | Interpersonal Domain: Family | 1.35 units on a scale | Standard Error 0.49 |
| Non FES-Row Subjects | Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI) | Intrapersonal Domain: Health | 1.24 units on a scale | Standard Error 0.2 |
| Non FES-Row Subjects | Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI) | Interpersonal Domain: Friends | 1.56 units on a scale | Standard Error 0.44 |
| Non FES-Row Subjects | Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI) | Intrapersonal Domain: Beliefs/Attitudes | 0.06 units on a scale | Standard Error 0.05 |
Primary
Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis
important information to inform on user and design needs and potential market for at home FES-row system.
Time frame: baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Current FES-Row Subjects | Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis | Cerebral palsy | 0 Participants |
| Current FES-Row Subjects | Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis | Multiple schlerosis | 1 Participants |
| Current FES-Row Subjects | Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis | Spinal cord injury | 9 Participants |
| Current FES-Row Subjects | Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis | Spina bifida | 0 Participants |
| Non FES-Row Subjects | Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis | Spina bifida | 1 Participants |
| Non FES-Row Subjects | Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis | Cerebral palsy | 1 Participants |
| Non FES-Row Subjects | Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis | Spinal cord injury | 5 Participants |
| Non FES-Row Subjects | Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis | Multiple schlerosis | 3 Participants |
Primary
Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used
important information to inform on user and design needs and potential market for at home FES-row system.
Time frame: baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Current FES-Row Subjects | Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used | Manual wheelchair | 7 Participants |
| Current FES-Row Subjects | Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used | Power wheelchair | 3 Participants |
| Non FES-Row Subjects | Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used | Manual wheelchair | 8 Participants |
| Non FES-Row Subjects | Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used | Power wheelchair | 2 Participants |
Primary
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. Minimum score is 0 (least satisfied), maximum score is 5 (most satisfied).
Time frame: baseline
Population: Only subjects who were currently training with functional electrical stimulation (FES) rowing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Current FES-Row Subjects | Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST 2.0) | 4.45 score on scale | Standard Error 0.16 |