NCT05959837

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. 1.What exercise intensity of activity do users achieve on the rower for steady state and interval rowing plans?
  2. 2.What assistance is required for setup and usage of the adaptive rower?
  3. 3.What do users think about the ease of use and what is their satisfaction with the adaptive rower?

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

July 10, 2023

Last Update Submit

August 2, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

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

    during exercise intervention

  • Rest Time minutes and seconds: recorded by study personnel

    during exercise intervention

  • Type of Rower Handle Used

    Immediately after the intervention

  • Grip Assist Used

    Immediately after the intervention

  • Trunk Assist Used

    Immediately after the intervention

  • +1 more secondary outcomes

Other Outcomes (1)

  • Recommendations for changes

    Immediately after the intervention

Study Arms (1)

Single Group Intervention Arm

EXPERIMENTAL

Exercise intervention with adaptive rower

Other: Adaptive Rowing Exercise

Interventions

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.

Single Group Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • current self-reported pressure wounds
  • pain with rowing motion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Research Center

Columbia, South Carolina, 29208, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 29070812BACKGROUND
  • 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.

    PMID: 33814890BACKGROUND
  • 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.

    PMID: 35110695BACKGROUND
  • 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.

    PMID: 33730952BACKGROUND
  • 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.

    PMID: 35487894BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Elizabeth Regan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 25, 2023

Study Start

July 24, 2023

Primary Completion

October 1, 2024

Study Completion

June 1, 2025

Last Updated

August 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations