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

NCT ID: NCT04740060

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-10
• Study Completion Date: 2022-05-01

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).

Conditions

Stroke; Hemiparesis; Walking, Difficulty

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Augmented Feedback without Virtual Reality(VR)

Group Type: EXPERIMENTAL

Augmented Feedback without Virtual Reality(VR

Intervention Type: OTHER

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.

Augmented Feedback with Non-Game based VR

Group Type: EXPERIMENTAL

Augmented Feedback with Non-Game based VR

Intervention Type: OTHER

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.

Augmented Feedback with Game based VR

Group Type: EXPERIMENTAL

Augmented Feedback with Game based VR

Intervention Type: OTHER

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.

Interventions

Augmented Feedback without Virtual Reality(VR

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

Augmented Feedback with Non-Game based VR

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

Augmented Feedback with Game based VR

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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Carmen Capo-Lugo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UAB

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300000718

Identifier Type: -

Identifier Source: org_study_id