Usability of the Adapted Rower for People With Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adaptive Rowing Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility 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.
Sites / Locations
- Public Health Research CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Group Intervention Arm
Arm Description
Exercise intervention with adaptive rower
Outcomes
Primary Outcome Measures
Heart Rate, (beats per minute), mean and range at rest, mean and range during steady state portion, mean and range during interval portion
Heart rate will be recorded at rest and throughout the exercise intervention using a polar heart rate monitor and actigraph.
Rate of Perceived Exertion (RPE)-Borg 6-20 Scale
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)
Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain verbalized by participant and recorded by study personnel
participant complaints of discomfort or pain verbally stated along with location
Physical Activity Enjoyment Scale (Short); average score (1-5)
A 4 item Likert scale survey to evaluate the enjoyment of the activity (1-5, higher means better outcome)
System Useability Scale, average score (1-5)
A ten question Likert scale survey to evaluate a system for ease of use (1-5, higher means better outcome)
Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain
participant complaints of discomfort or pain with free form location on web survey
Secondary Outcome Measures
Exercise Time (minutes and seconds): recorded by study personnel
Steady State Portion: Total Exercise Time; Interval Portion: Exercise time for each interval
Rest Time minutes and seconds: recorded by study personnel
Steady State Portion: duration for each rest break; Interval Portion: duration for each rest break
Type of Rower Handle Used
standard row, bicycle, free handles, recorded by study personnel
Grip Assist Used
none, hook, velcro, combined; recorded by study personnel
Trunk Assist Used
none, corset support, backpack harness; recorded by study personnel
Assistance Provided at Setup
minimum, moderate, maximum with description; recorded by study personnel
Full Information
NCT ID
NCT05959837
First Posted
July 10, 2023
Last Updated
July 24, 2023
Sponsor
University of South Carolina
Collaborators
Foundation for Physical Therapy, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05959837
Brief Title
Usability of the Adapted Rower for People With Spinal Cord Injury
Official Title
Usability of the Adapted Rower for People With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
Foundation for Physical Therapy, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Group Intervention Arm
Arm Type
Experimental
Arm Description
Exercise intervention with adaptive rower
Intervention Type
Other
Intervention Name(s)
Adaptive Rowing Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart Rate, (beats per minute), mean and range at rest, mean and range during steady state portion, mean and range during interval portion
Description
Heart rate will be recorded at rest and throughout the exercise intervention using a polar heart rate monitor and actigraph.
Time Frame
During Exercise intervention
Title
Rate of Perceived Exertion (RPE)-Borg 6-20 Scale
Description
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)
Time Frame
During Exercise intervention
Title
Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain verbalized by participant and recorded by study personnel
Description
participant complaints of discomfort or pain verbally stated along with location
Time Frame
During Exercise intervention
Title
Physical Activity Enjoyment Scale (Short); average score (1-5)
Description
A 4 item Likert scale survey to evaluate the enjoyment of the activity (1-5, higher means better outcome)
Time Frame
Immediately after the intervention
Title
System Useability Scale, average score (1-5)
Description
A ten question Likert scale survey to evaluate a system for ease of use (1-5, higher means better outcome)
Time Frame
Immediately after the intervention
Title
Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain
Description
participant complaints of discomfort or pain with free form location on web survey
Time Frame
Two days post intervention
Secondary Outcome Measure Information:
Title
Exercise Time (minutes and seconds): recorded by study personnel
Description
Steady State Portion: Total Exercise Time; Interval Portion: Exercise time for each interval
Time Frame
during exercise intervention
Title
Rest Time minutes and seconds: recorded by study personnel
Description
Steady State Portion: duration for each rest break; Interval Portion: duration for each rest break
Time Frame
during exercise intervention
Title
Type of Rower Handle Used
Description
standard row, bicycle, free handles, recorded by study personnel
Time Frame
Immediately after the intervention
Title
Grip Assist Used
Description
none, hook, velcro, combined; recorded by study personnel
Time Frame
Immediately after the intervention
Title
Trunk Assist Used
Description
none, corset support, backpack harness; recorded by study personnel
Time Frame
Immediately after the intervention
Title
Assistance Provided at Setup
Description
minimum, moderate, maximum with description; recorded by study personnel
Time Frame
Immediately after the intervention
Other Pre-specified Outcome Measures:
Title
Recommendations for changes
Description
Free form comments from participants on any changes to rower design, setup or exercise protocols
Time Frame
Immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Regan
Phone
803-777-5028
Email
eregan@mailbox.sc.edu
Facility Information:
Facility Name
Public Health Research Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth W Regan, DPT, PhD
Phone
704-609-2409
Email
eregan@mailbox.sc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29070812
Citation
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;:
Results Reference
background
PubMed Identifier
33814890
Citation
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.
Results Reference
background
PubMed Identifier
35110695
Citation
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.
Results Reference
background
PubMed Identifier
33730952
Citation
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.
Results Reference
background
PubMed Identifier
35487894
Citation
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.
Results Reference
background
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Usability of the Adapted Rower for People With Spinal Cord Injury
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