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NCT Number: NCT05959837

Usability of the Adapted Rower for People With Spinal Cord Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Health Research Center

Columbia, South Carolina, 29208, United States

Location status: Recruiting

Location contact

Elizabeth W Regan, DPT, PhD

CONTACT

[email protected]

704-609-2409

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptive Rowing Exercise

Other

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 outcomes

  1. 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.

  2. 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)

  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

    Time frame: During Exercise intervention

    participant complaints of discomfort or pain verbally stated along with location

  4. Physical Activity Enjoyment Scale (Short); average score (1-5)

    Time frame: 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)

    Time frame: 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

    Time frame: Two days post intervention

    participant complaints of discomfort or pain with free form location on web survey

Secondary outcomes

  1. Exercise Time (minutes and seconds): recorded by study personnel

    Time frame: 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

    Time frame: during exercise intervention

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

  3. Type of Rower Handle Used

    Time frame: Immediately after the intervention

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

  4. Grip Assist Used

    Time frame: Immediately after the intervention

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

  5. Trunk Assist Used

    Time frame: Immediately after the intervention

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

  6. Assistance Provided at Setup

    Time frame: Immediately after the intervention

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

Other outcomes

  1. Recommendations for changes

    Time frame: Immediately after the intervention

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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Regan

CONTACT

[email protected]

803-777-5028

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Foundation for Physical Therapy, Inc.

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 25, 2023
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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