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

NCT05144113 | Completed Results

• 2 other identifiers: 2020P0031321R41HD102267-01A1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Paralysis, Legs

Outcome Measures

Primary Outcomes (5)

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

  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)

  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

  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

  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. Minimum score is 0 (least satisfied), maximum score is 5 (most satisfied).

  baseline

Study Arms (2)

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.

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.

Interventions

Survey subjects to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and FES-rowing. BEHAVIORAL

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.

Current FES-Row Subjects; Non-FES-Row Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Paraplegia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. J.Andrew Taylor
• Organization: Spaulding Rehabilitation Hospital

jandrew_taylor@hms.harvard.edu

616-758-5503

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: December 3, 2021
• Study Start: March 16, 2021
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)