FES-Rowing: Preventing the Secondary Conditions of Paralysis Through Vigorous Exercise

• ClinicalTrials.gov Identifier: NCT05144113
• Recruitment Status: Completed
• First Posted: December 3, 2021
• Last Update Posted: November 15, 2022
• Sponsor: Spaulding Rehabilitation Hospital
• Information provided by (Responsible Party): J. Andrew Taylor, Spaulding Rehabilitation Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Paralysis, Legs	Behavioral: Survey subjects to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and 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, 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: FES-Rowing: Preventing the Secondary Conditions of Paralysis Through Vigorous Exercise
• Actual Study Start Date: March 21, 2021
• Actual Primary Completion Date: August 22, 2022
• Actual Study Completion Date: August 22, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Behavioral: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI) Questionnaire [ Time Frame: baseline ]
   measures barriers to physical activity across the intrapersonal, interpersonal, organizational, and community domains.
2. Physical Activity and Disability Survey (PADS) Questionnaire [ Time Frame: baseline ]
   measures physical activity for people with chronic neurological conditions.
3. Demographic and Mobility Questionnaire [ Time Frame: baseline ]
   Important information to inform on user and design needs and potential market for at home FES-row system.
4. Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) [ Time Frame: baseline ]
   (FES-row participants only): measures satisfaction with current FES-row system used in the ExPD Program.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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.

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

Contacts and Locations

Locations

United States, Massachusetts

Spaulding Hospital Cambridge

Cambridge, Massachusetts, United States, 02138

Sponsors and Collaborators

Spaulding Rehabilitation Hospital

More Information

• Responsible Party: J. Andrew Taylor, Associate Professor, Spaulding Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT05144113
• Other Study ID Numbers: 2020P003132
• First Posted: December 3, 2021
• Last Update Posted: November 15, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to share IPD.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Paralysis; Paraplegia; Neurologic Manifestations; Nervous System Diseases