Usability of the Adapted Rower for People With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Usability of the Adapted Rower for People With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959837
• Other study ID #: Pro00129966
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: University of South Carolina
• Contact: Elizabeth Regan
• Phone: 803-777-5028
• Email: eregan[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Public Health Research Center	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	Foundation for Physical Therapy, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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;: — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recommendations for changes	Free form comments from participants on any changes to rower design, setup or exercise protocols	Immediately after the intervention
Primary	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.	During Exercise intervention
Primary	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)	During Exercise intervention
Primary	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	During Exercise intervention
Primary	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)	Immediately after the intervention
Primary	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)	Immediately after the intervention
Primary	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	Two days post intervention
Secondary	Exercise Time (minutes and seconds): recorded by study personnel	Steady State Portion: Total Exercise Time; Interval Portion: Exercise time for each interval	during exercise intervention
Secondary	Rest Time minutes and seconds: recorded by study personnel	Steady State Portion: duration for each rest break; Interval Portion: duration for each rest break	during exercise intervention
Secondary	Type of Rower Handle Used	standard row, bicycle, free handles, recorded by study personnel	Immediately after the intervention
Secondary	Grip Assist Used	none, hook, velcro, combined; recorded by study personnel	Immediately after the intervention
Secondary	Trunk Assist Used	none, corset support, backpack harness; recorded by study personnel	Immediately after the intervention
Secondary	Assistance Provided at Setup	minimum, moderate, maximum with description; recorded by study personnel	Immediately after the intervention