This study will conduct a preliminary evaluation of and obtain user data on a novel game-based visual interface for stroke gait training. Study participants will complete one session comprising exposure to gait biofeedback systems in an order determined by block randomization (3 blocks). Participants will be exposed to 3 types of biofeedback interfaces:
Condition or disease | Intervention/treatment | Phase |
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Gait, Hemiplegic Stroke | Other: Game without AR Other: Game with AR Other: Traditional Biofeedback Interface | Not Applicable |
Stroke is the leading cause of adult disability. Even after discharge from rehabilitation, residual gait deficits are prevalent in stroke survivors, leading to decreased walking speed and endurance. Because gait dysfunctions limit community mobility, stroke survivors and rehabilitation clinicians consider restoration of walking a major goal of rehabilitation. Several challenges and research gaps limit the effectiveness of current clinical gait rehabilitation practices. While there is consensus that stroke survivors benefit from gait rehabilitation, agreement is lacking on which specific training interventions are most efficacious. The long-term goal of this proposal is to address these challenges by developing personalized, engaging, salient gait training treatments founded on evidence from neuroscience, biomechanics, motor learning, and gaming.
Real-time biofeedback is a promising gait training intervention for targeting specific biomechanical impairments. Biofeedback can enhance an individual's awareness of the impairment targeted during gait training, enabling self-correction of aberrant gait patterns.
In response to treadmill training combined with visual and auditory real-time biofeedback, able-bodied individuals can increase AGRF unilaterally for the targeted limb. Thus, AGRF biofeedback may be a beneficial strategy to target unilateral propulsive deficits in people post-stroke. Incorporation of gaming interfaces for gait biofeedback can increase patient motivation, distract participants from fatigue or boredom, and encourage greater numbers of repetitions during gait training.
The long-term goal of this study is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The researchers aim to address a major challenge for rehabilitation clinicians - to make gait training appealing and meaningful so that patients engage in sufficient repetitions, intensity, and challenge to maximize therapeutic effectiveness. The study premise is that post-stroke individuals will demonstrate greater engagement, motivation, and therapeutic benefits during gait training sessions involving biofeedback when training incorporates intuitive, entertaining, game-based interfaces. Outcomes of the study will include measures of participant engagement, user-reports and survey-responses on motivation, fatigue, game characteristics, and adverse effects (e.g. nausea, dizziness) during game exposure. In addition to this clinical trial with stroke survivor participants, data about the game interface will be collected by having able-bodied neuro-rehabilitation clinicians try the 3 types of biofeedback interventions.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | 12 post-stroke individuals will complete 3 different biofeedback interfaces in random order. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | The study outcomes will be collected by an evaluator (licensed physical therapist) who was not involved in study design and is blinded to the biofeedback assignment/order. |
Primary Purpose: | Treatment |
Official Title: | Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation |
Estimated Study Start Date : | May 2021 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | October 2021 |
Arm | Intervention/treatment |
---|---|
Game without AR, Game with AR, Traditional Interface
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game without AR, game with AR, traditional interface
|
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training
Other: Game with AR During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training
Other: Traditional Biofeedback Interface For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training
|
Game without AR, Traditional Interface, Game with AR
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game without AR, traditional interface, game with AR
|
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training
Other: Game with AR During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training
Other: Traditional Biofeedback Interface For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training
|
Game with AR, Game without AR, Traditional Interface
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game with AR, game without AR, traditional interface
|
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training
Other: Game with AR During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training
Other: Traditional Biofeedback Interface For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training
|
Game with AR, Traditional Interface, Game without AR
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game with AR, traditional interface, game without AR
|
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training
Other: Game with AR During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training
Other: Traditional Biofeedback Interface For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training
|
Traditional Interface, Game without AR, Game with AR
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: traditional interface, game without AR, game with AR
|
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training
Other: Game with AR During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training
Other: Traditional Biofeedback Interface For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training
|
Traditional Interface, Game with AR, Game without AR
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: traditional interface, game with AR, game without AR
|
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training
Other: Game with AR During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training
Other: Traditional Biofeedback Interface For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training
|
Ages Eligible for Study: | 30 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Post-Stroke Participants:
Exclusion Criteria for Post-Stroke Participants:
Contact: Trisha Kesar, PT, PhD | 404-712-5803 | tkesar@emory.edu |
United States, Georgia | |
Emory Rehabilitation Hospital | Recruiting |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Trisha Kesar, PT, PhD | Emory University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 8, 2019 | ||||||||
First Posted Date ICMJE | July 10, 2019 | ||||||||
Last Update Posted Date | April 13, 2021 | ||||||||
Estimated Study Start Date ICMJE | May 2021 | ||||||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation | ||||||||
Official Title ICMJE | Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation | ||||||||
Brief Summary |
This study will conduct a preliminary evaluation of and obtain user data on a novel game-based visual interface for stroke gait training. Study participants will complete one session comprising exposure to gait biofeedback systems in an order determined by block randomization (3 blocks). Participants will be exposed to 3 types of biofeedback interfaces:
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Detailed Description |
Stroke is the leading cause of adult disability. Even after discharge from rehabilitation, residual gait deficits are prevalent in stroke survivors, leading to decreased walking speed and endurance. Because gait dysfunctions limit community mobility, stroke survivors and rehabilitation clinicians consider restoration of walking a major goal of rehabilitation. Several challenges and research gaps limit the effectiveness of current clinical gait rehabilitation practices. While there is consensus that stroke survivors benefit from gait rehabilitation, agreement is lacking on which specific training interventions are most efficacious. The long-term goal of this proposal is to address these challenges by developing personalized, engaging, salient gait training treatments founded on evidence from neuroscience, biomechanics, motor learning, and gaming. Real-time biofeedback is a promising gait training intervention for targeting specific biomechanical impairments. Biofeedback can enhance an individual's awareness of the impairment targeted during gait training, enabling self-correction of aberrant gait patterns. In response to treadmill training combined with visual and auditory real-time biofeedback, able-bodied individuals can increase AGRF unilaterally for the targeted limb. Thus, AGRF biofeedback may be a beneficial strategy to target unilateral propulsive deficits in people post-stroke. Incorporation of gaming interfaces for gait biofeedback can increase patient motivation, distract participants from fatigue or boredom, and encourage greater numbers of repetitions during gait training. The long-term goal of this study is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The researchers aim to address a major challenge for rehabilitation clinicians - to make gait training appealing and meaningful so that patients engage in sufficient repetitions, intensity, and challenge to maximize therapeutic effectiveness. The study premise is that post-stroke individuals will demonstrate greater engagement, motivation, and therapeutic benefits during gait training sessions involving biofeedback when training incorporates intuitive, entertaining, game-based interfaces. Outcomes of the study will include measures of participant engagement, user-reports and survey-responses on motivation, fatigue, game characteristics, and adverse effects (e.g. nausea, dizziness) during game exposure. In addition to this clinical trial with stroke survivor participants, data about the game interface will be collected by having able-bodied neuro-rehabilitation clinicians try the 3 types of biofeedback interventions. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: 12 post-stroke individuals will complete 3 different biofeedback interfaces in random order. Masking: Single (Outcomes Assessor)Masking Description: The study outcomes will be collected by an evaluator (licensed physical therapist) who was not involved in study design and is blinded to the biofeedback assignment/order. Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
12 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | October 2021 | ||||||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria for Post-Stroke Participants:
Exclusion Criteria for Post-Stroke Participants:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 90 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04013971 | ||||||||
Other Study ID Numbers ICMJE | IRB00106866 1R21HD095138-01 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Trisha Kesar, PT, PhD, Emory University | ||||||||
Study Sponsor ICMJE | Emory University | ||||||||
Collaborators ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
Investigators ICMJE |
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PRS Account | Emory University | ||||||||
Verification Date | April 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |