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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD095138-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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 randomization. Participants will be exposed to 2 types of biofeedback interfaces:
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 anterior ground reaction forces (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 2 types of biofeedback interventions.
Study participants will complete one sessions comprising exposure to gait biofeedback systems in a randomized order. Participants will be exposed to 2 types of biofeedback interfaces: (i) newly developed game-based interface (projector screen display), and (ii) traditional, non-game interface.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-stroke Participants | Other | Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided. |
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| Able-bodied Participants | Other | Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGRF Biofeedback Game | Other | During the AGRF biofeedback game participants will walk on a split-belt treadmill with a projector or screen 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 for 4 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak AGRF | Paretic leg (right leg for post-stroke participants) or targeted leg (right leg for able-bodied participants) peak push off force (peak AGRF) was calculated from GRF data. Higher values indicate greater push off force. | After each biofeedback interface session on Day 1 |
| Trailing Limb Angle (TLA) | The trailing limb angle contributes to increased propulsion during walking. Trailing limb angle is a kinematic variable derived from 3-dimensional motion capture, which measures the orientation of the leg with respect to the center of mass at the stance to swing transition. In stroke survivors, trailing limb angle increases as walking speed increases. | After each biofeedback interface session on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Likert Enjoyment/Boredom Scale Domain Scores | The Likert Enjoyment Boredom Scale is a 4-item instrument evaluating user reports of perceived effort in four different domains: Enjoyment/Fun, Boredom, Motivation, and Challenge. To assess each domain, participants are asked:
Each question is scored on a 8-point scale from 1 to 8, where the intensity of each domain is scored as 1 = not at all to 8 = very much/a lot. For the individual domains, higher scores are interpreted as the participant experiencing greater enjoyment/fun, boredom, motivation, or challenge. |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Feedback | User experiences about the feedback will be obtained in the form of subjective comments. | Day 1, after each of the biofeedback sessions |
| Heart Rate | Participants wear a heart rate monitor placed on the chest under clothing (Polar USA, Lake Success ,NY) and heart rate is collected after every sixty seconds of walking. |
Inclusion Criteria for Post-Stroke Participants:
Exclusion Criteria for Post-Stroke Participants:
Inclusion Criteria for Able-bodied Participants:
Exclusion Criteria for Able-bodied Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Trisha Kesar, PT, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Rehabilitation Hospital | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41510277 | Derived | Alterman BL, Slusarenko A, Kim M, Alam Z, Fowler D, Krishnan S, Coleman MG, Wolf SL, Kesar TM. An innovative gamified gait biofeedback interface targeting propulsion: feasibility and preliminary effects. Res Sq [Preprint]. 2025 Dec 9:rs.3.rs-8099435. doi: 10.21203/rs.3.rs-8099435/v1. |
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Individual participant data that underlie results, after de-identification, will be available for sharing.
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Individual participant data will be available for sharing beginning 9 months and ending 36 months after the article publication.
Data will be available for sharing with investigators whose proposed used of the data has been approved by an independent review committee identified for this purpose. Data will be shared for the purposes of achieving the aims in the approved proposal. Proposals should be directed to trisha.m.kesar@emory.edu. To access the data, requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Post-stroke Participants | Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided. AGRF Biofeedback Game: During the AGRF biofeedback game participants walk on a split-belt treadmill with a projector or screen display. Participants receive real-time information or feedback about ongoing gait performance parameters while they are walking. The participants are exposed to the AGRF biofeedback game for 4 minutes. 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 are exposed to the traditional biofeedback interface for 4 minutes. Control Condition: Participants complete a control walk with out feedback. |
| FG001 | Able-bodied Participants | Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided. AGRF Biofeedback Game: During the AGRF biofeedback game participants walk on a split-belt treadmill with a projector or screen display. Participants receive real-time information or feedback about ongoing gait performance parameters while they are walking. The participants are exposed to the AGRF biofeedback game for 4 minutes. 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 are exposed to the traditional biofeedback interface for 4 minutes. Control Condition: Participants complete a control walk with out feedback. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Baseline Analysis Population includes participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Post-stroke Participants | Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided. |
| BG001 | Able-bodied Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak AGRF | Paretic leg (right leg for post-stroke participants) or targeted leg (right leg for able-bodied participants) peak push off force (peak AGRF) was calculated from GRF data. Higher values indicate greater push off force. | This analysis includes participants who completed the trial and had the right leg studied. One post-stroke participant had their left side affected and was not included in this analysis. | Posted | Mean | Standard Deviation | Newtons | After each biofeedback interface session on Day 1 |
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Information about adverse events was collected during the biofeedback sessions on Day 1 of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Post-stroke Participants | Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trisha Kesar, PT, PhD | Emory University | 404-712-5803 | tkesar@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2023 | Dec 13, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 5, 2023 | Aug 15, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This study aims to enroll 12 post-stroke and 12 able-bodied individuals who will complete gait trials with 2 different biofeedback interfaces in each experimental session.
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The study outcomes will comprise objective biomechanical measures derived using motion capture, which will be processed by lab personnel who are blinded to the gait training condition.
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| Traditional Biofeedback Interface | Other | 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 4 minutes. |
|
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| Control Condition | Other | Participants will complete a control walk with out feedback. |
|
| Day 1, after each of the biofeedback interface sessions |
| NASA Task Load Index (NASA - TLX) | The NASA task load index (NASA - TLX) evaluates user reports of perceived effort in six subscales of Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each subscale is scored on a 21-point scale from 1 to 21, where very low demand/perfect performance = 1 and very high demand/failure = 21. A total score is created by taking the average of each subscale; the total score ranges from 1 to 21 with higher scores indicating that the task is very demanding to perform. | Day 1, after each of the biofeedback interface sessions |
| Borg Rating of Perceived Exertion (RPE) Scale | The Borg Rating of Perceived Exertion (RPE) Scale asks respondents to report how hard it feels like their body is working with a single item. Perceived exertion is rated on a scale from 6 to 20 where "no exertion at all" is scored as 6 and "maximal exertion" is scored as 20. Ratings between 12 and 14 are generally considered as a moderate intensity level. | Day 1, during each of the biofeedback interface sessions |
| User Evaluation Questionnaire (UEQ) Score | User experience of the biofeedback game is assessed with a 26-item user evaluation questionnaire (UEQ). Participants indicate how they found the session to be for a variety of usability qualities, including likability, speed, and meeting expectations. Responses are given on a 7-point scale where scale where 1 = the most agreement with the adjective on the left, 4 = a neutral response, and 7 = the most agreement with the adjective on the right. For some items high scores are associated with positive perceptions, while for other items low low scores are associated with positive perceptions. Items were grouped according to whether high or low scores meant positive perceptions and separate summary scores were obtained by calculating the mean score for the items included, so that the summary scores range from t to 7. | Day 1, after each of the biofeedback sessions |
| Day 1, during and after each of the biofeedback sessions |
| Skin Impedance | A galvanic skin resistance (GSR) device is wrapped around the index and middle finger on the subject's left or right hand ensuring it was not on the bone of the fingers nor tightly wrapped to avoid blood flow restriction. These data are collected for 3 minutes when the subject is presented with the biofeedback interface. | Day 1, during each of the biofeedback sessions |
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Able-bodied Participants |
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided. |
|
|
| Primary | Trailing Limb Angle (TLA) | The trailing limb angle contributes to increased propulsion during walking. Trailing limb angle is a kinematic variable derived from 3-dimensional motion capture, which measures the orientation of the leg with respect to the center of mass at the stance to swing transition. In stroke survivors, trailing limb angle increases as walking speed increases. | This analysis includes participants who completed the trial and had the right leg studied. One post-stroke participant had their left side affected and was not included in this analysis. | Posted | Mean | Standard Deviation | degrees | After each biofeedback interface session on Day 1 |
|
|
|
| Secondary | Likert Enjoyment/Boredom Scale Domain Scores | The Likert Enjoyment Boredom Scale is a 4-item instrument evaluating user reports of perceived effort in four different domains: Enjoyment/Fun, Boredom, Motivation, and Challenge. To assess each domain, participants are asked:
Each question is scored on a 8-point scale from 1 to 8, where the intensity of each domain is scored as 1 = not at all to 8 = very much/a lot. For the individual domains, higher scores are interpreted as the participant experiencing greater enjoyment/fun, boredom, motivation, or challenge. | Posted | Mean | Standard Deviation | score on a scale | Day 1, after each of the biofeedback interface sessions |
|
|
|
| Secondary | NASA Task Load Index (NASA - TLX) | The NASA task load index (NASA - TLX) evaluates user reports of perceived effort in six subscales of Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each subscale is scored on a 21-point scale from 1 to 21, where very low demand/perfect performance = 1 and very high demand/failure = 21. A total score is created by taking the average of each subscale; the total score ranges from 1 to 21 with higher scores indicating that the task is very demanding to perform. | Posted | Mean | Standard Deviation | score on a scale | Day 1, after each of the biofeedback interface sessions |
|
|
|
| Secondary | Borg Rating of Perceived Exertion (RPE) Scale | The Borg Rating of Perceived Exertion (RPE) Scale asks respondents to report how hard it feels like their body is working with a single item. Perceived exertion is rated on a scale from 6 to 20 where "no exertion at all" is scored as 6 and "maximal exertion" is scored as 20. Ratings between 12 and 14 are generally considered as a moderate intensity level. | Posted | Mean | Standard Deviation | units on a scale | Day 1, during each of the biofeedback interface sessions |
|
|
|
| Secondary | User Evaluation Questionnaire (UEQ) Score | User experience of the biofeedback game is assessed with a 26-item user evaluation questionnaire (UEQ). Participants indicate how they found the session to be for a variety of usability qualities, including likability, speed, and meeting expectations. Responses are given on a 7-point scale where scale where 1 = the most agreement with the adjective on the left, 4 = a neutral response, and 7 = the most agreement with the adjective on the right. For some items high scores are associated with positive perceptions, while for other items low low scores are associated with positive perceptions. Items were grouped according to whether high or low scores meant positive perceptions and separate summary scores were obtained by calculating the mean score for the items included, so that the summary scores range from t to 7. | Posted | Mean | Standard Deviation | score on a scale | Day 1, after each of the biofeedback sessions |
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| Other Pre-specified | Qualitative Feedback | User experiences about the feedback will be obtained in the form of subjective comments. | Not Posted | Day 1, after each of the biofeedback sessions | Participants |
| Other Pre-specified | Heart Rate | Participants wear a heart rate monitor placed on the chest under clothing (Polar USA, Lake Success ,NY) and heart rate is collected after every sixty seconds of walking. | Not Posted | Day 1, during and after each of the biofeedback sessions | Participants |
| Other Pre-specified | Skin Impedance | A galvanic skin resistance (GSR) device is wrapped around the index and middle finger on the subject's left or right hand ensuring it was not on the bone of the fingers nor tightly wrapped to avoid blood flow restriction. These data are collected for 3 minutes when the subject is presented with the biofeedback interface. | Not Posted | Day 1, during each of the biofeedback sessions | Participants |
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Able-bodied Participants | Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Boredom Domain Score for Traditional Biofeedback Interface |
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| Boredom Domain Score for AGRF Biofeedback Game |
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| Motivation Domain Score for Traditional Biofeedback Interface |
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| Motivation Domain Score for AGRF Biofeedback Game |
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| Challenge Domain Score for Traditional Biofeedback Interface |
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| Challenge Domain Score for AGRF Biofeedback Game |
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| Traditional Biofeedback Interface -Items Where Low Score Value Indicates Positive Perceptions |
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| AGRF Biofeedback Game - Items Where Low Score Value Indicates Positive Perceptions |
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