Clinical trial NCT05959837: 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
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy, Inc.
First posted: 2023-07-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Heart Rate, (beats per minute), mean and range at rest, mean and range during steady state portion, mean and range during interval portion
timeFrame: During Exercise intervention
measure: Rate of Perceived Exertion (RPE)-Borg 6-20 Scale
timeFrame: During Exercise intervention
measure: Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain verbalized by participant and recorded by study personnel
timeFrame: During Exercise intervention
measure: Physical Activity Enjoyment Scale (Short); average score (1-5)
timeFrame: Immediately after the intervention
measure: System Useability Scale, average score (1-5)
timeFrame: Immediately after the intervention
measure: Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain
timeFrame: Two days post intervention
Secondary outcomes:
measure: Exercise Time (minutes and seconds): recorded by study personnel
timeFrame: during exercise intervention
measure: Rest Time minutes and seconds: recorded by study personnel
timeFrame: during exercise intervention
measure: Type of Rower Handle Used
timeFrame: Immediately after the intervention
measure: Grip Assist Used
timeFrame: Immediately after the intervention
measure: Trunk Assist Used
timeFrame: Immediately after the intervention
measure: Assistance Provided at Setup
timeFrame: Immediately after the intervention
Other outcomes:
measure: Recommendations for changes
timeFrame: Immediately after the intervention
Locations:
city: Columbia
country: United States
facility: Public Health Research Center
state: South Carolina
Study officials:
References:
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.
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.
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.
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.
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.