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临床试验/NCT05959837
NCT05959837招募中不适用

Usability of the Adapted Rower for People With Spinal Cord Injury

University of South Carolina2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain verbalized by participant and recorded by study personnel

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Pain Scale (0-10 visual analog scale, higher means worse pain ) and body location of pain verbalized by participant and recorded by study personnel

时间窗: During Exercise intervention

participant complaints of discomfort or pain verbally stated along with location

System Useability Scale, average score (1-5)

时间窗: 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

时间窗: Two days post intervention

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

Heart Rate, (beats per minute), mean and range at rest, mean and range during steady state portion, mean and range during interval portion

时间窗: 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

时间窗: 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)

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

时间窗: Immediately after the intervention

A 4 item Likert scale survey to evaluate the enjoyment of the activity (1-5, higher means better outcome)

次要结局

  • Grip Assist Used(Immediately after the intervention)
  • Exercise Time (minutes and seconds): recorded by study personnel(during exercise intervention)
  • Rest Time minutes and seconds: recorded by study personnel(during exercise intervention)
  • Assistance Provided at Setup(Immediately after the intervention)
  • Type of Rower Handle Used(Immediately after the intervention)
  • Trunk Assist Used(Immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Regan

Clinical Assistant Professor

University of South Carolina

研究点 (2)

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