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

Completed

• Conditions: Paralysis, Legs

• Registration Number: NCT05144113
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Study Timeline

• Study Start: 2021-03-16
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-03
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-22
• Results First Submitted: 2023-12-20
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Results First Posted: 2024-07-08
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

• Under 18 years of age
• no lower-limb paralysis
• People who do not use a wheelchair as their primary means of mobility

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

Spaulding Hospital Cambridge; 🇺🇸 Cambridge, Massachusetts, United States