StrokeNCT04740060
Effects of Different Types of Augmented Feedback on Intrinsic Motivation and Spatiotemporal Gait Performance After Stroke
A study testing Augmented Feedback without Virtual Reality(VR, Augmented Feedback with Non-Game based VR and Augmented Feedback with Game based VR in people with Stroke and Hemiparesis, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Hemiparesis, Walking, Difficulty
- What is being tested?
- Augmented Feedback without Virtual Reality(VR, Augmented Feedback with Non-Game based VR and Augmented Feedback with Game based VR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jul 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UAB
Birmingham, Alabama, 35294
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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)
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.
Read the 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
- Being tested
- Augmented Feedback without Virtual Reality(VR, Augmented Feedback with Non-Game based VR, Augmented Feedback with Game based VR
- Keywords
- Walking Speed, Step-length, Virtual Reality, Exergames
- Medical subject headings
- Stroke, Paresis, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Feedback without Virtual Reality(VROther
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 VROther
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 VROther
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.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Feedback without Virtual Reality(VR) | Experimental | Not described Receives: Other: Augmented Feedback without Virtual Reality(VR |
| Augmented Feedback with Non-Game based VR | Experimental | Not described Receives: Other: Augmented Feedback with Non-Game based VR |
| Augmented Feedback with Game based VR | Experimental | Not described Receives: Other: Augmented Feedback with Game based VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three Minutes
Step Length
Maximum step length will be measured as traveled distance by the foot in centimeters.
Measured: About Five Minutes
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
Measured: About Three Minutes
Secondary outcomes (6)
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).
Measured: About Five Minutes
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).
Measured: About Three Minutes
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.
Measured: About Five Minutes
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?".
Measured: About Three Seconds
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).
Measured: About Five Minutes
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.
Measured: About Four Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start10 Jul 2021
- Primary completion30 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Capo-Lugo, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740060
- Sponsor's protocol ID
- IRB-300000718
- Status last verified
- May 2022
- First submitted
- 1 Feb 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04740060
- Acronym / sponsor ID
- IRB-300000718
- Conditions
- Stroke, Hemiparesis, Walking, Difficulty
- Keywords
- Walking Speed, Step-length, Virtual Reality, Exergames
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Augmented Feedback without Virtual Reality(VR) | Experimental | Other: Augmented Feedback without Virtual Reality(VR |
| Augmented Feedback with Non-Game based VR | Experimental | Other: Augmented Feedback with Non-Game based VR |
| Augmented Feedback with Game based VR | Experimental | Other: Augmented Feedback with Game based VR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Feedback without Virtual Reality(VRFor 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. | Other | Augmented Feedback without Virtual Reality(VR) |
| Augmented Feedback with Non-Game based VRFor 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. | Other | Augmented Feedback with Non-Game based VR |
| Augmented Feedback with Game based VRFor 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. | Other | Augmented Feedback with Game based VR |
Primary outcome
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.
Step Length
Time frame: About Five Minutes
Maximum step length will be measured as traveled distance by the foot in centimeters.
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
6 secondary outcomes
Apathy Evaluation Scale-Self rated version (AES-S)
Time frame: About Five Minutes
Activities-Specific Balance Confidence Scale (ABC)
Time frame: About Three Minutes
Perceived competence,Perceived choice, and Pressure/tension
Time frame: About Five Minutes
Borg Rating of Perceived Exertion (RPE)
Time frame: About Three Seconds
Flow State Scale (FSS)
Time frame: About Five Minutes
Video games and VR experience
Time frame: About Four Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Feedback without Virtual Reality(VR, Augmented Feedback with Non-Game based VR and Augmented Feedback with Game based VR in people with Stroke and Hemiparesis, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed (time frame: Three Minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.