Usability of the Adapted Rower for People With Spinal Cord Injury

August 2, 2024 updated by: Elizabeth Regan, University of South Carolina

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • Recruiting
        • Public Health Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Group Intervention Arm
Exercise intervention with adaptive rower
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During Exercise intervention
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)
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
Time Frame: During Exercise intervention
participant complaints of discomfort or pain verbally stated along with location
During Exercise intervention
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)
Immediately after the intervention
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)
Immediately after the intervention
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
Two days post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
during exercise intervention
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
during exercise intervention
Type of Rower Handle Used
Time Frame: Immediately after the intervention
standard row, bicycle, free handles, recorded by study personnel
Immediately after the intervention
Grip Assist Used
Time Frame: Immediately after the intervention
none, hook, velcro, combined; recorded by study personnel
Immediately after the intervention
Trunk Assist Used
Time Frame: Immediately after the intervention
none, corset support, backpack harness; recorded by study personnel
Immediately after the intervention
Assistance Provided at Setup
Time Frame: Immediately after the intervention
minimum, moderate, maximum with description; recorded by study personnel
Immediately after the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recommendations for changes
Time Frame: Immediately after the intervention
Free form comments from participants on any changes to rower design, setup or exercise protocols
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Foundation for Physical Therapy, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00129966

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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