Spinal Cord InjuriesNCT05959837
Usability of the Adapted Rower for People With Spinal Cord Injury
A study testing Adaptive Rowing Exercise in people with Spinal Cord Injuries, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Adaptive Rowing Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- current self-reported pressure wounds
- pain with rowing motion.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Public Health Research Center
Columbia, South Carolina, 29208
Elizabeth W Regan, DPT, PhD, 704-609-2409, eregan@mailbox.sc.edu
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Adaptive Rowing Exercise
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Rowing ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Intervention Arm | Experimental | Exercise intervention with adaptive rower Receives: Other: Adaptive Rowing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: Two days post intervention
Secondary outcomes (6)
Exercise Time (minutes and seconds): recorded by study personnel
Steady State Portion: Total Exercise Time; Interval Portion: Exercise time for each interval
Measured: during exercise intervention
Rest Time minutes and seconds: recorded by study personnel
Steady State Portion: duration for each rest break; Interval Portion: duration for each rest break
Measured: during exercise intervention
Type of Rower Handle Used
standard row, bicycle, free handles, recorded by study personnel
Measured: Immediately after the intervention
Grip Assist Used
none, hook, velcro, combined; recorded by study personnel
Measured: Immediately after the intervention
Trunk Assist Used
none, corset support, backpack harness; recorded by study personnel
Measured: Immediately after the intervention
Assistance Provided at Setup
minimum, moderate, maximum with description; recorded by study personnel
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start24 Jul 2023
- Primary completionOct 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc.
- Responsible party
- Principal investigator, Elizabeth Regan, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959837
- Sponsor's protocol ID
- Pro00129966
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29070812Farkas 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.
PubMed 33814890Sawatzky 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.
PubMed 35110695Wong 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.
PubMed 33730952Hansen 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.
PubMed 35487894
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of the Adapted Rower for People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05959837
- Acronym / sponsor ID
- Pro00129966
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc.
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Intervention Arm | Experimental | Other: Adaptive Rowing ExerciseExercise intervention with adaptive rower |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- current self-reported pressure wounds
- pain with rowing motion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Rowing ExerciseParticipants 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. | Other | Single Group Intervention Arm |
Primary outcome
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.
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)
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
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)
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)
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
6 secondary outcomes
Exercise Time (minutes and seconds): recorded by study personnel
Time frame: during exercise intervention
Rest Time minutes and seconds: recorded by study personnel
Time frame: during exercise intervention
Type of Rower Handle Used
Time frame: Immediately after the intervention
Grip Assist Used
Time frame: Immediately after the intervention
Trunk Assist Used
Time frame: Immediately after the intervention
Assistance Provided at Setup
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 29070812Martin 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.
- Background: PubMed 33814890Farkas 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.
- Background: PubMed 35110695Sawatzky 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.
- Background: PubMed 33730952Wong 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.
- Background: PubMed 35487894Hansen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Rowing Exercise in people with Spinal Cord Injuries, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Regan (803-777-5028, eregan@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05959837, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.