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

July 2, 2024 updated by: J. Andrew Taylor, Spaulding Rehabilitation Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Spaulding Hospital Cambridge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI)
Time Frame: 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.
baseline
Barriers to Physical Activity and Disability Survey (BPAD-S)
Time Frame: 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.
baseline
Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis
Time Frame: baseline
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
Time Frame: baseline
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)
Time Frame: 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).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spaulding Rehabilitation Hospital

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2021

Primary Completion (Actual)

August 22, 2022

Study Completion (Actual)

August 22, 2022

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P003132
  • 1R41HD102267-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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