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Usability of the Adapted Rower for People With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT05959837
Recruitment Status : Recruiting
First Posted : July 25, 2023
Last Update Posted : July 27, 2023
Sponsor:
Collaborator:
Foundation for Physical Therapy, Inc.
Information provided by (Responsible Party):
Elizabeth Regan, University of South Carolina

Study Description
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Brief Summary:

The goal of this clinical trial is to examine usability of a locally built adaptive rower for people with spinal cord injury using an established and tested design.

The main questions it aims to answer are:

  1. What exercise intensity of activity do users achieve on the rower for steady state and interval rowing plans?
  2. What assistance is required for setup and usage of the adaptive rower?
  3. What do users think about the ease of use and what is their satisfaction with the adaptive rower?

Participants will complete a one-time exercise session with two adaptive rower bouts (10-15 minutes each) with a rest period in between.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Adaptive Rowing Exercise Not Applicable

Detailed Description:
A single group rolling prospective cohort study with a target of 15 participants will evaluate the initial design prototype using the an existing adaptive rower design. Participants will have one visit to the University of South Carolina Rehabilitation lab. Participants will receive an orientation to the rowing machine and available handle, grip and trunk support options. Training will be provided in proper rowing technique and use of the rate of perceived exertion scale. Participants will be fitted with a heart rate monitoring device and resting heart rate established. Participants will perform two bouts of rowing exercise each with a 2-minute warm up and cool down in addition to the following: (1)10 minutes of steady state rowing with goals to achieve moderate intensity exertion levels, followed by a variable rest period to return exertion and heart rate to initial levels, (2) 10 minutes of interval rowing alternating between one minute of low-moderate intensity and 30 seconds of moderate-vigorous intensity. Participants heart rate will be monitored and recorded throughout the testing period, with rate of perceived exertion at start, midpoint and end of steady state period, and at start, at each interval, and at end in interval period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Usability of the Adapted Rower for People With Spinal Cord Injury
Actual Study Start Date : July 24, 2023
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Group Intervention Arm
Exercise intervention with adaptive rower
 Other: Adaptive Rowing Exercise
Participants will perform two bouts of rowing exercise each with a 2-minute warm up and cool down in addition to the following: (1)10 minutes of steady state rowing with goals to achieve moderate intensity exertion levels, followed by a variable rest period to return exertion and heart rate to initial levels, (2) 10 minutes of interval rowing alternating between one minute of low-moderate intensity and 30 seconds of moderate-vigorous intensity.


Outcome Measures
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Primary Outcome Measures :
  1. Heart Rate, (beats per minute), mean and range at rest, mean and range during steady state portion, mean and range during interval portion [ Time Frame: During Exercise intervention ]
    Heart rate will be recorded at rest and throughout the exercise intervention using a polar heart rate monitor and actigraph.

  2. Rate of Perceived Exertion (RPE)-Borg 6-20 Scale [ Time Frame: During Exercise intervention ]
    RPE will be verbally stated by participant and recorded by study personnel at beginning, mid and end of steady state portion, and at each interval for interval exercise. (RPE, 6-20, higher means higher intensity)

  3. Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain verbalized by participant and recorded by study personnel [ Time Frame: During Exercise intervention ]
    participant complaints of discomfort or pain verbally stated along with location

  4. Physical Activity Enjoyment Scale (Short); average score (1-5) [ Time Frame: Immediately after the intervention ]
    A 4 item Likert scale survey to evaluate the enjoyment of the activity (1-5, higher means better outcome)

  5. System Useability Scale, average score (1-5) [ Time Frame: Immediately after the intervention ]
    A ten question Likert scale survey to evaluate a system for ease of use (1-5, higher means better outcome)

  6. Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain [ Time Frame: Two days post intervention ]
    participant complaints of discomfort or pain with free form location on web survey


Secondary Outcome Measures :
  1. Exercise Time (minutes and seconds): recorded by study personnel [ Time Frame: during exercise intervention ]
    Steady State Portion: Total Exercise Time; Interval Portion: Exercise time for each interval

  2. Rest Time minutes and seconds: recorded by study personnel [ Time Frame: during exercise intervention ]
    Steady State Portion: duration for each rest break; Interval Portion: duration for each rest break

  3. Type of Rower Handle Used [ Time Frame: Immediately after the intervention ]
    standard row, bicycle, free handles, recorded by study personnel

  4. Grip Assist Used [ Time Frame: Immediately after the intervention ]
    none, hook, velcro, combined; recorded by study personnel

  5. Trunk Assist Used [ Time Frame: Immediately after the intervention ]
    none, corset support, backpack harness; recorded by study personnel

  6. Assistance Provided at Setup [ Time Frame: Immediately after the intervention ]
    minimum, moderate, maximum with description; recorded by study personnel


Other Outcome Measures:
  1. Recommendations for changes [ Time Frame: Immediately after the intervention ]
    Free form comments from participants on any changes to rower design, setup or exercise protocols


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • use a wheelchair for mobility,
  • can perform the rowing motion with their arms
  • have enough grip strength to maintain grip on the rower handle with or without grip assist straps
  • are cleared to exercise through the electronic physical readiness questionnaire or physician release

Exclusion Criteria:

  • current self-reported pressure wounds
  • pain with rowing motion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05959837


Contacts
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Contact: Elizabeth Regan 803-777-5028 eregan@mailbox.sc.edu

Locations
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United States, South Carolina
Public Health Research Center Recruiting
Columbia, South Carolina, United States, 29208
Contact: Elizabeth W Regan, DPT, PhD    704-609-2409    eregan@mailbox.sc.edu   
Sponsors and Collaborators
University of South Carolina
Foundation for Physical Therapy, Inc.
More Information
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Publications:

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Responsible Party: Elizabeth Regan, Clinical Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT05959837    
Other Study ID Numbers: Pro00129966
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System