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

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: Paralysis, Legs
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

2

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, 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.

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) Questionnaire	measures barriers to physical activity across the intrapersonal, interpersonal, organizational, and community domains.	baseline
Physical Activity and Disability Survey (PADS) Questionnaire	measures physical activity for people with chronic neurological conditions.	baseline
Demographic and Mobility Questionnaire	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.	baseline

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 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): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Paraplegia
• Other Study ID Numbers: 2020P003132

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