CompletedNot Applicable

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

United States20 participantsStarted 2021-03-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI)

Timeframe: baseline

Barriers to Physical Activity and Disability Survey (BPAD-S)

Timeframe: baseline

Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis

Timeframe: baseline

Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used

Timeframe: baseline

Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST 2.0)

Timeframe: baseline

Trial details

NCT IDNCT05144113

SponsorSpaulding Rehabilitation Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-22

Results submitted2023-12-20

View on ClinicalTrials.gov More Paralysis, Legs trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI)

Timeframe: baseline

Barriers to Physical Activity and Disability Survey (BPAD-S)

Timeframe: baseline

Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis

Timeframe: baseline

Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used

Timeframe: baseline

Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST 2.0)

Timeframe: baseline