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临床试验/NCT04740060
NCT04740060已完成不适用

Major Research Instrumentation Program: Development of an Innovative Instrument on Robot-Aided Virtual Rehabilitation for Intelligent Physical Training of Individuals With Disabilities (iRAPID)

University of Alabama at Birmingham4 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
4
主要终点
Step Length

研究概览

简要总结

Investigate development of an Innovative Instrument on Robot-Aided and Virtual Reality Rehabilitation for Intelligent Physical Training (i.e. gait and stepping) of Individuals post-stroke.

详细描述

The participants will be asked to test the effectiveness of up to two games. Participants are stroke survivors with post-stroke hemiparesis, which is affecting their ability to walk and step.

Participants will be asked to go to the UAB Spain Rehabilitation Center where they will tested up to two games in a maximum of two sessions. Each session will last approximately two hours. Testing of the games will be done in a robotic device known as the KineAssistTM-MX (KA-MX).

The KA-MX is a robotic device that allows full freedom of motion for the body and pelvis during walking and balance tasks, and also helps to control your posture to enhance your balance and stability. The KA-MX also offers you safety while training and will catch you if you lose your balance. This assistance is available while participants are strapped into the device with a harness and the device allows them to walk over the treadmill with minimal things affecting their walking.

Before starting the performance conditions, participants will be asked to fill out a questionnaire that asks about demographics, apathy, balance confidence,and their experience with VR and gaming.

The study team will help participants into the KineAssist MX, and once secured in the device, they will be allowed to get acclimated to the device prior to approach the performance conditions. Then, they will perform three walking or stepping conditions that measure their maximum walking speed or maximum step length.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Individuals with hemiparesis in a chronic and stable stroke stage.
  • Able to follow instructions.
  • Able to walk independently without using assistive devices for up to three minutes.

排除标准

  • Coronary heart disease.
  • Inability to stand and walk independently.
  • Other neurological diseases that impact balance and mobility other than the stroke.
  • Visual impairments that impact their ability to see, focus on and track movable objects.

结局指标

主要结局

Step Length

时间窗: About Five Minutes

Maximum step length will be measured as traveled distance by the foot in centimeters.

Walking Speed

时间窗: Three Minutes

ast walking speed will be measured on the KineAssist and quantified based on the distance covered in one minute as a meter per second.

Intrinsic Motivation

时间窗: About Three Minutes

Intrinsic Motivation Inventory (IMI) will be used as measurement tool after performing each of the three conditions. The IMI consists of 22 questions rating from 1-7 in four subscales (interest/enjoyment, perceived competence, perceived choice, and pressure/tension). For this study, we will only use the Interest/Enjoyment subscale which contains seven questions and is considered as a self-report measure of intrinsic motivation

次要结局

  • Apathy Evaluation Scale-Self rated version (AES-S)(About Five Minutes)
  • Borg Rating of Perceived Exertion (RPE)(About Three Seconds)
  • Activities-Specific Balance Confidence Scale (ABC)(About Three Minutes)
  • Perceived competence,Perceived choice, and Pressure/tension(About Five Minutes)
  • Flow State Scale (FSS)(About Five Minutes)
  • Video games and VR experience(About Four Minutes)

研究者

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

Carmen Capo-Lugo

Principal Investigator

University of Alabama at Birmingham

研究点 (4)

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