Clinical trial NCT04740060: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Walking, Difficulty
Keywords: Walking Speed
Step-length
Virtual Reality
Exergames
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: Walking Speed
timeFrame: Three Minutes
measure: Step Length
timeFrame: About Five Minutes
measure: Intrinsic Motivation
timeFrame: About Three Minutes
Secondary outcomes:
measure: Apathy Evaluation Scale-Self rated version (AES-S)
timeFrame: About Five Minutes
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: About Three Minutes
measure: Perceived competence,Perceived choice, and Pressure/tension
timeFrame: About Five Minutes
measure: Borg Rating of Perceived Exertion (RPE)
timeFrame: About Three Seconds
measure: Flow State Scale (FSS)
timeFrame: About Five Minutes
measure: Video games and VR experience
timeFrame: About Four Minutes
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: