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Clinical Trials/NCT04740060
NCT04740060CompletedNot Applicable

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 Birmingham2 sites in 1 country18 target enrollmentStarted: July 10, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
2
Primary Endpoint
Step Length

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

Augmented Feedback without Virtual Reality(VR)

Experimental

Intervention: Augmented Feedback without Virtual Reality(VR (Other)

Augmented Feedback with Non-Game based VR

Experimental

Intervention: Augmented Feedback with Non-Game based VR (Other)

Augmented Feedback with Game based VR

Experimental

Intervention: Augmented Feedback with Game based VR (Other)

Outcomes

Primary Outcomes

Step Length

Time Frame: About Five Minutes

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

Walking Speed

Time Frame: 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

Time Frame: 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

Secondary Outcomes

  • Video games and VR experience(About Four Minutes)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carmen Capo-Lugo

Principal Investigator

University of Alabama at Birmingham

Study Sites (2)

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