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| ID | Type | Description | Link |
|---|---|---|---|
| 1R41HD102267-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey subjects to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and FES-rowing. | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| 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. | baseline |
| 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. | baseline |
| 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. | baseline |
| 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). | baseline |
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Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Hospital Cambridge | Cambridge | Massachusetts | 02138 | United States |
There is no plan to share IPD.
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Outpatient department of Rehabilitation Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2021 | Dec 19, 2023 |
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| FG001 | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | baseline |
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| 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. | 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). | Posted | Count of Participants | Participants | baseline |
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| 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. | Posted | Count of Participants | Participants | baseline |
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| 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. | Posted | Count of Participants | Participants | baseline |
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| 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). | Only subjects who were currently training with functional electrical stimulation (FES) rowing. | Posted | Mean | Standard Error | score on scale | baseline |
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1 Day, single visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J.Andrew Taylor | Spaulding Rehabilitation Hospital | 616-758-5503 | jandrew_taylor@hms.harvard.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 25, 2024 | Jun 25, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Between 18 and 65 years |
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| >=65 years |
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| Interpersonal Domain: Friends |
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| Interpersonal Domain: Family |
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