Gait, HemiplegicNCT04013971
Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation
A study testing AGRF Biofeedback Game and Traditional Biofeedback Interface in people with Gait, Hemiplegic and Stroke, run by Emory University at 1 site in United States.
Trial 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 randomization. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait, Hemiplegic, Stroke
- What is being tested?
- AGRF Biofeedback Game and Traditional Biofeedback Interface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 30 to 90 years
- chronic stroke (>6 months post stroke) affecting the right leg
- ambulatory with or without the use of a cane or walker
- able to walk for 2 minutes at the self-selected speed without an orthoses
- resting heart rate 40-100 beats per minute
- age 18 to 90 years
- no history of neurologic disease
- no history of orthopedic disease or injury affecting the lower extremity
Who cannot join
- cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements)
- history of lower extremity joint replacement
- inability to communicate with investigators
- neglect/hemianopia, or unexplained dizziness in last 6 months
- neurologic conditions other than stroke
- orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking or cause pain during walking
Show all 10Show fewer
- history of neurologic disease
- history of orthopedic disease or injury to the lower extremity in the past 6 months
- pain or discomfort during walking
- cardiovascular or medical condition affecting ability to exercise or walk
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Rehabilitation Hospital
Atlanta, Georgia, 30322
About this study
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:
- newly developed game-based interface (projector screen display)
- traditional, non-game interface
Read the 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 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.
- Conditions
- Gait, Hemiplegic, Stroke
- Being tested
- AGRF Biofeedback Game, Traditional Biofeedback Interface, Control Condition
- Keywords
- stroke, gait rehabilitation, game
- Medical subject headings
- Gait Disorders, Neurologic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGRF Biofeedback GameOther
Also called gait training bout
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.
Traditional Biofeedback InterfaceOther
Also called gait training
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.
Control ConditionOther
Participants will complete a control walk with out feedback.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: AGRF Biofeedback Game; Other: Traditional Biofeedback Interface; Other: Control Condition |
| 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. Receives: Other: AGRF Biofeedback Game; Other: Traditional Biofeedback Interface; Other: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After each biofeedback interface session on Day 1
Secondary outcomes (4)
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:
- How much enjoyment/fun did you feel in the previous walking trial?
- How much boredom did you feel in the previous walking trial?
- How much motivation did you feel in the previous walking trial?
- How much challenge did you feel in the previous walking trial?
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1, after each of the biofeedback sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start4 Apr 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gait, HemiplegicStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Trisha Kesar, Emory University
- Investigators
- Trisha Kesar, PT, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013971
- Sponsor's protocol ID
- IRB00106866
- Other IDs
- 1R21HD095138-01
- Status last verified
- Apr 2025
- First submitted
- 8 Jul 2019
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results, after de-identification, will be available for sharing.
Publications
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.
PubMed 41510277
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation
- ClinicalTrials.gov ID
- NCT04013971
- Acronym / sponsor ID
- IRB00106866
- Conditions
- Gait, Hemiplegic, Stroke
- Keywords
- stroke, gait rehabilitation, game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- newly developed game-based interface (projector screen display)
- traditional, non-game interface
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Post-stroke Participants | Other | Other: AGRF Biofeedback Game, Other: Traditional Biofeedback Interface, Other: Control ConditionPost-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. |
| Able-bodied Participants | Other | Other: AGRF Biofeedback Game, Other: Traditional Biofeedback Interface, Other: Control ConditionAble-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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 30 to 90 years
- chronic stroke (>6 months post stroke) affecting the right leg
- ambulatory with or without the use of a cane or walker
- able to walk for 2 minutes at the self-selected speed without an orthoses
- resting heart rate 40-100 beats per minute
Key exclusion criteria (10 listed)
- cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements)
- history of lower extremity joint replacement
- inability to communicate with investigators
- neglect/hemianopia, or unexplained dizziness in last 6 months
- neurologic conditions other than stroke
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 |
|---|---|---|
| AGRF Biofeedback GameAlso: gait training boutDuring 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. | Other | Able-bodied Participants, Post-stroke Participants |
| Traditional Biofeedback InterfaceAlso: gait trainingFor 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. | Other | Able-bodied Participants, Post-stroke Participants |
| Control ConditionParticipants will complete a control walk with out feedback. | Other | Able-bodied Participants, Post-stroke Participants |
Primary outcome
Peak AGRF
Time frame: After each biofeedback interface session on Day 1
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.
Trailing Limb Angle (TLA)
Time frame: After each biofeedback interface session on Day 1
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.
4 secondary outcomes
Likert Enjoyment/Boredom Scale Domain Scores
Time frame: Day 1, after each of the biofeedback interface sessions
NASA Task Load Index (NASA - TLX)
Time frame: Day 1, after each of the biofeedback interface sessions
Borg Rating of Perceived Exertion (RPE) Scale
Time frame: Day 1, during each of the biofeedback interface sessions
User Evaluation Questionnaire (UEQ) Score
Time frame: Day 1, after each of the biofeedback sessions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41510277Alterman 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results, after de-identification, will be available for sharing.
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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.
Trisha Kesar, PT, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AGRF Biofeedback Game and Traditional Biofeedback Interface in people with Gait, Hemiplegic and Stroke, run by Emory University at 1 site 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 8 inclusion and 10 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 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peak AGRF (time frame: After each biofeedback interface session on Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04013971, which also lists 1 linked publication.
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 25 Apr 2025.