Usability of the Adapted Rower for People With Spinal Cord Injury

Sponsor
University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT05959837
Collaborator
Foundation for Physical Therapy, Inc. (Industry)
15
1
1
10.3
1.5

Study Details

Study Description

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
  • Other: Adaptive Rowing Exercise
N/A

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

Study Type:
Interventional
Anticipated 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 :
Jul 24, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

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 [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 [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 [During Exercise intervention]

    participant complaints of discomfort or pain verbally stated along with location

  4. Physical Activity Enjoyment Scale (Short); average score (1-5) [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) [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 [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 [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 [during exercise intervention]

    Steady State Portion: duration for each rest break; Interval Portion: duration for each rest break

  3. Type of Rower Handle Used [Immediately after the intervention]

    standard row, bicycle, free handles, recorded by study personnel

  4. Grip Assist Used [Immediately after the intervention]

    none, hook, velcro, combined; recorded by study personnel

  5. Trunk Assist Used [Immediately after the intervention]

    none, corset support, backpack harness; recorded by study personnel

  6. Assistance Provided at Setup [Immediately after the intervention]

    minimum, moderate, maximum with description; recorded by study personnel

Other Outcome Measures

  1. Recommendations for changes [Immediately after the intervention]

    Free form comments from participants on any changes to rower design, setup or exercise protocols

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Public Health Research Center Columbia South Carolina United States 29208

Sponsors and Collaborators

  • University of South Carolina
  • Foundation for Physical Therapy, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elizabeth Regan, Clinical Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier:
NCT05959837
Other Study ID Numbers:
  • Pro00129966
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2023