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Effects of Different Types of Augmented Feedback on Intrinsic Motivation and Spatiotemporal Gait Performance After Stroke

Primary Purpose

Stroke, Hemiparesis, Walking, Difficulty

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augmented Feedback without Virtual Reality(VR
Augmented Feedback with Non-Game based VR
Augmented Feedback with Game based VR
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Walking Speed, Step-length, Virtual Reality, Exergames

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB
  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Augmented Feedback without Virtual Reality(VR)

Augmented Feedback with Non-Game based VR

Augmented Feedback with Game based VR

Arm Description

Outcomes

Primary Outcome Measures

Walking Speed
ast walking speed will be measured on the KineAssist and quantified based on the distance covered in one minute as a meter per second.
Step Length
Maximum step length will be measured as traveled distance by the foot in centimeters.
Intrinsic Motivation
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 Outcome Measures

Apathy Evaluation Scale-Self rated version (AES-S)
The Apathy Evaluation Scale-Self rated version (AES-S) was developed to quantify and characterize apathy. The AES-S consists of 18 questions on an ordinal scale (i.e., not at all, slightly, somewhat, a lot).
Activities-Specific Balance Confidence Scale (ABC)
The ABC Scale is a 16-item self-report measure in which patients rate their balance confidence for performing various activities rating from 0-100 (i.e., a score of zero represents no confidence, a score of 100 represents complete confidence).
Perceived competence,Perceived choice, and Pressure/tension
We will use Intrinsic Motivation Inventory subscales (perceived competence, perceived choice, and pressure/tension) contain 5 questions rating from 1-7 where 1 means not at all true and 7 means very true.
Borg Rating of Perceived Exertion (RPE)
The Borg Rating of Perceived Exertion (RPE) is a psychophysical category scale with rating ranging from 6 as no exertion at all to 20 as maximal exertion, will be conducted every 30 seconds in order to evaluate participants level of perceived exertion. We will hold up the scale on a clipboard and asked participants, "how hard are you working?".
Flow State Scale (FSS)
The Flow State Scale (FSS) will be conducted after each condition. The Flow state is a positive experiential state, occurs when the performer is connected to the performance in a situation where personal skill equals the requiredchallenge. The FSS consists of 36-items in nine subscales representing the dimensions of flow using a Likert scale with five levels (i.e., strongly disagree, disagree, neither agree nor disagree, agree, strongly agree).
Video games and VR experience
Video games and VR experience questions (i.e., have you ever played video games? have you ever experienced virtual reality (VR) technology before?) will be asked to evaluate participants' experiences and thoughts regarding video games in general.

Full Information

First Posted
February 1, 2021
Last Updated
May 16, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04740060
Brief Title
Effects of Different Types of Augmented Feedback on Intrinsic Motivation and Spatiotemporal Gait Performance After Stroke
Official Title
Major Research Instrumentation Program: Development of an Innovative Instrument on Robot-Aided Virtual Rehabilitation for Intelligent Physical Training of Individuals With Disabilities (iRAPID)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. Participants will play one of our two developed VR-exergames. One of the games is called "Racing Game" and its purpose is to test people's walking speed and ask them to race against virtual competitors to incentivize them to walk faster over a 1 minute period. Another game, called "Stepping Game" tests participant's ability to step farther. Beside the games, participants will perform maximum walking or maximum stepping with simple VR environment as well as without VR environment. The games have been developed to be tested and will be modified based on feedback from participants. Participants will have the option to participate in one or all two tests (i.e., walking and stepping). While in the KA-MX, during each condition performance (i.e., walking or stepping), participants heart rate will be monitored by a pulse oximeter placed on their finger or through a chest strapped heart rate monitor. Participants will be periodically asked to state how hard they feel they are working (Rating of Perceived Exertion). Additionally, participants maximum walking speed or maximum step length taken in the device during performance testing will be counted and recorded. At the end of each condition, participants will be given a questionnaires to complete regarding their motivation and flow state (i.e., the positive experiential state where participants skill equal to the required challenge).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis, Walking, Difficulty
Keywords
Walking Speed, Step-length, Virtual Reality, Exergames

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Augmented Feedback without Virtual Reality(VR)
Arm Type
Experimental
Arm Title
Augmented Feedback with Non-Game based VR
Arm Type
Experimental
Arm Title
Augmented Feedback with Game based VR
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Augmented Feedback without Virtual Reality(VR
Intervention Description
For Walking Speed:One-minute fast walking with visual augmented feedback without VR interface (we ask participants to look at a screen where their walking speed and distance are tracked and increase their speed). For Step Length: Maximum step length with visual augmented feedback without VR interface in which we ask participants to look at a screen where their step length is displayed and attempt to increase their step length up.
Intervention Type
Other
Intervention Name(s)
Augmented Feedback with Non-Game based VR
Intervention Description
For Walking Speed:One-minute fast walking with basic VR interface (we ask participants to look at a screen where their avatar walker representative will be represented in a virtual walking environment and try to make the avatar walk faster). For Step Length: Maximum step length with basic VR interface in which we ask participants to look at their avatar feet in a virtual stepping environment and step with the avatar foot as far as possible.
Intervention Type
Other
Intervention Name(s)
Augmented Feedback with Game based VR
Intervention Description
For Walking Speed: One-minute fast walking with the VR Racing exergame (we ask participants to look at a screen where their avatar walker representative present in a virtual racing environment with other avatar racers and try to beat the avatar racers). For Step Length: Maximum step length with the VR Stepping Exergame (we ask participants to look at their avatar legs and avatar animals in a virtual stepping environment and try to step over the avatar animals without touching the animal.
Primary Outcome Measure Information:
Title
Walking Speed
Description
ast walking speed will be measured on the KineAssist and quantified based on the distance covered in one minute as a meter per second.
Time Frame
Three Minutes
Title
Step Length
Description
Maximum step length will be measured as traveled distance by the foot in centimeters.
Time Frame
About Five Minutes
Title
Intrinsic Motivation
Description
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
Time Frame
About Three Minutes
Secondary Outcome Measure Information:
Title
Apathy Evaluation Scale-Self rated version (AES-S)
Description
The Apathy Evaluation Scale-Self rated version (AES-S) was developed to quantify and characterize apathy. The AES-S consists of 18 questions on an ordinal scale (i.e., not at all, slightly, somewhat, a lot).
Time Frame
About Five Minutes
Title
Activities-Specific Balance Confidence Scale (ABC)
Description
The ABC Scale is a 16-item self-report measure in which patients rate their balance confidence for performing various activities rating from 0-100 (i.e., a score of zero represents no confidence, a score of 100 represents complete confidence).
Time Frame
About Three Minutes
Title
Perceived competence,Perceived choice, and Pressure/tension
Description
We will use Intrinsic Motivation Inventory subscales (perceived competence, perceived choice, and pressure/tension) contain 5 questions rating from 1-7 where 1 means not at all true and 7 means very true.
Time Frame
About Five Minutes
Title
Borg Rating of Perceived Exertion (RPE)
Description
The Borg Rating of Perceived Exertion (RPE) is a psychophysical category scale with rating ranging from 6 as no exertion at all to 20 as maximal exertion, will be conducted every 30 seconds in order to evaluate participants level of perceived exertion. We will hold up the scale on a clipboard and asked participants, "how hard are you working?".
Time Frame
About Three Seconds
Title
Flow State Scale (FSS)
Description
The Flow State Scale (FSS) will be conducted after each condition. The Flow state is a positive experiential state, occurs when the performer is connected to the performance in a situation where personal skill equals the requiredchallenge. The FSS consists of 36-items in nine subscales representing the dimensions of flow using a Likert scale with five levels (i.e., strongly disagree, disagree, neither agree nor disagree, agree, strongly agree).
Time Frame
About Five Minutes
Title
Video games and VR experience
Description
Video games and VR experience questions (i.e., have you ever played video games? have you ever experienced virtual reality (VR) technology before?) will be asked to evaluate participants' experiences and thoughts regarding video games in general.
Time Frame
About Four Minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be determined

Learn more about this trial

Effects of Different Types of Augmented Feedback on Intrinsic Motivation and Spatiotemporal Gait Performance After Stroke

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