- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05959837
Usability of the Adapted Rower for People With Spinal Cord Injury
July 24, 2023 updated by: Elizabeth Regan, University of South Carolina
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:
- What exercise intensity of activity do users achieve on the rower for steady state and interval rowing plans?
- What assistance is required for setup and usage of the adaptive rower?
- 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elizabeth Regan
- Phone Number: 803-777-5028
- Email: eregan@mailbox.sc.edu
Study Locations
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South Carolina
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Columbia, South Carolina, United States, 29208
- Recruiting
- Public Health Research Center
-
Contact:
- Elizabeth W Regan, DPT, PhD
- Phone Number: 704-609-2409
- Email: eregan@mailbox.sc.edu
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Group Intervention Arm
Exercise intervention with adaptive rower
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During Exercise intervention
|
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)
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During Exercise intervention
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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
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participant complaints of discomfort or pain verbally stated along with location
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During Exercise intervention
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Physical Activity Enjoyment Scale (Short); average score (1-5)
Time Frame: Immediately after the intervention
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A 4 item Likert scale survey to evaluate the enjoyment of the activity (1-5, higher means better outcome)
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Immediately after the intervention
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System Useability Scale, average score (1-5)
Time Frame: Immediately after the intervention
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A ten question Likert scale survey to evaluate a system for ease of use (1-5, higher means better outcome)
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Immediately after the intervention
|
Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain
Time Frame: Two days post intervention
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participant complaints of discomfort or pain with free form location on web survey
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Two days post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Time (minutes and seconds): recorded by study personnel
Time Frame: during exercise intervention
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Steady State Portion: Total Exercise Time; Interval Portion: Exercise time for each interval
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during exercise intervention
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Rest Time minutes and seconds: recorded by study personnel
Time Frame: during exercise intervention
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Steady State Portion: duration for each rest break; Interval Portion: duration for each rest break
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during exercise intervention
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Type of Rower Handle Used
Time Frame: Immediately after the intervention
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standard row, bicycle, free handles, recorded by study personnel
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Immediately after the intervention
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Grip Assist Used
Time Frame: Immediately after the intervention
|
none, hook, velcro, combined; recorded by study personnel
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Immediately after the intervention
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Trunk Assist Used
Time Frame: Immediately after the intervention
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none, corset support, backpack harness; recorded by study personnel
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Immediately after the intervention
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Assistance Provided at Setup
Time Frame: Immediately after the intervention
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minimum, moderate, maximum with description; recorded by study personnel
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Immediately after the intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recommendations for changes
Time Frame: Immediately after the intervention
|
Free form comments from participants on any changes to rower design, setup or exercise protocols
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Immediately after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Martin Ginis KA, van der Scheer JW, Latimer-Cheung AE, Barrow A, Bourne C, Carruthers P, Bernardi M, Ditor DS, Gaudet S, de Groot S, Hayes KC, Hicks AL, Leicht CA, Lexell J, Macaluso S, Manns PJ, McBride CB, Noonan VK, Pomerleau P, Rimmer JH, Shaw RB, Smith B, Smith KM, Steeves JD, Tussler D, West CR, Wolfe DL, Goosey-Tolfrey VL. Evidence-based scientific exercise guidelines for adults with spinal cord injury: an update and a new guideline. Spinal Cord. 2018 Apr;56(4):308-321. doi: 10.1038/s41393-017-0017-3. Epub 2017 Oct 25. Erratum In: Spinal Cord. 2018 Oct 4;:
- Farkas GJ, Gorgey AS, Dolbow DR, Berg AS, Gater DR Jr. Energy Expenditure, Cardiorespiratory Fitness, and Body Composition Following Arm Cycling or Functional Electrical Stimulation Exercises in Spinal Cord Injury: A 16-Week Randomized Controlled Trial. Top Spinal Cord Inj Rehabil. 2021;27(1):121-134. doi: 10.46292/sci20-00065.
- Sawatzky B, Herrington B, Choi K, Ben Mortenson W, Borisoff J, Sparrey C, Laskin JJ. Acute physiological comparison of sub-maximal exercise on a novel adapted rowing machine and arm crank ergometry in people with a spinal cord injury. Spinal Cord. 2022 Aug;60(8):694-700. doi: 10.1038/s41393-022-00757-2. Epub 2022 Feb 3.
- Wong RN, Stewart AL, Sawatzky B, Laskin JJ, Borisoff J, Mattie J, Sparrey CJ, Mortenson WB. Exploring exercise participation and the usability of the adaptive rower and arm crank ergometer through wheelchair users' perspectives. Disabil Rehabil. 2022 Jul;44(15):3915-3924. doi: 10.1080/09638288.2021.1894245. Epub 2021 Mar 17.
- Hansen RK, de Wit JLJ, Samani A, Laessoe U, Figlewski K, Larsen RG. Wheelchair-modified ergometer rowing exercise in individuals with spinal cord injury: a feasibility, acceptability, and preliminary efficacy study. Spinal Cord Ser Cases. 2022 Apr 30;8(1):48. doi: 10.1038/s41394-022-00518-6. Erratum In: Spinal Cord Ser Cases. 2022 May 16;8(1):55.
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)
July 24, 2023
Primary Completion (Estimated)
January 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
July 10, 2023
First Submitted That Met QC Criteria
July 17, 2023
First Posted (Actual)
July 25, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 24, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00129966
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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