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AGRF Biofeedback Game Followed by the Traditional biofeedback Interface for Stroke

N/A

Recruiting

Led By Trisha Kesar, PT, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Post-Stroke Participants: chronic stroke (>6 months post stroke) affecting the right leg

For Post-Stroke Participants: resting heart rate 40-100 beats per minute

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, after each of the biofeedback sessions

Awards & highlights

Study Summary

This trial will study a new game-based interface for stroke patients to use during gait training, to see if it is more effective than a traditional interface.

Who is the study for?

This trial is for individuals who have had a stroke more than 6 months ago, can walk on their own or with a cane/walker for at least 2 minutes without leg braces, and have a resting heart rate between 40-100 beats per minute.Check my eligibility

What is being tested?

The study tests two gait biofeedback systems for stroke rehabilitation: one is an innovative game-based interface displayed on a projector screen, and the other is a traditional non-game interface. Participants will try both in random order.See study design

What are the potential side effects?

Since this trial involves non-invasive biofeedback games and interfaces, side effects are minimal but may include fatigue or frustration during use. The VR option could potentially cause dizziness or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a stroke over 6 months ago that affected my right leg.

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My resting heart rate is between 40 and 100 bpm.

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I can walk for 2 minutes without any support after having a stroke.

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I am between 18 and 90 years old.

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I have never had a neurological disease.

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I am between 30 and 90 years old and have had a stroke.

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I can walk by myself or with a cane or walker after having a stroke.

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I can walk by myself or with a cane or walker.

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I can walk for 2 minutes without any support.

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I have no history of bone or joint issues in my legs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, after each of the biofeedback sessions

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, after each of the biofeedback sessions

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, after each of the biofeedback sessions for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peak AGRF

Trailing Limb Angle

Secondary outcome measures

Borg Rating of Perceived Exertion (RPE) Scale

Likert Enjoyment/Boredom Scale Scores

NASA Task Load Index (NASA - TLX)

+1 more

Other outcome measures

Heart Rate

Qualitative Feedback

Skin Impedance

Trial Design

3Treatment groups

Experimental Treatment

Group I: Traditional biofeedback Interface Followed by the AGRF Biofeedback GameExperimental Treatment3 Interventions

Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of the traditional, non-game-based, interface first and the AGRF biofeedback game second. Participants will also complete a control condition where no biofeedback is provided.

Group II: Optional Game with VRExperimental Treatment1 Intervention

Post-stroke participants attending a separate, optional, session to complete preliminary or exploratory testing of the VR version of the biofeedback game (head-mounted AR or VR display), which will be used to determine feasibility and preliminary effects of VR-based feedback on gait.

Group III: AGRF Biofeedback Game Followed by the Traditional biofeedback InterfaceExperimental Treatment3 Interventions

Post-stroke participants randomized to receive the two gait training biofeedback interfaces in the order of the AGRF biofeedback game first and the traditional, non-game-based, interface second. Participants will also complete a control condition where no biofeedback is provided.

0 / 10Eligibility criteria met

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,958 Previous Clinical Trials

2,673,491 Total Patients Enrolled

79 Trials studying Stroke

5,363 Patients Enrolled for Stroke

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,606 Total Patients Enrolled

28 Trials studying Stroke

347,988 Patients Enrolled for Stroke

Trisha Kesar, PT, PhDPrincipal Investigator - Emory University

Emory University

3 Previous Clinical Trials

119 Total Patients Enrolled

3 Trials studying Stroke

119 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Indeed, the details on clinicaltrials.gov confirm that this study is actively seeking eligible participants. The trial was first posted on April 4th, 2022 and last updated on January 29th, 2024. A total of 24 patients will be enrolled in this trial at a single site."

Answered by AI

Is the enrollment phase of this medical study currently ongoing?

"Indeed, the details on clinicaltrials.gov state that this trial is actively seeking participants. The initial posting of the trial was on April 4th, 2022 and it has been recently updated as of January 29th, 2024. Recruitment for this study aims to enroll a total of 24 individuals from a single site."

Answered by AI

Is the clinical trial open to participants who are below 18 years of age?

"To be considered eligible for this clinical trial, potential participants must meet the age criteria of being at least 18 years old and no older than 90."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The primary outcome measure for this trial is Trailing Limb Angle, which will be assessed after each biofeedback interface session on Day 1. Secondary outcomes include the NASA Task Load Index (NASA-TLX), which evaluates perceived effort in domains such as Mental Demand, Physical Demand, Temporal Demand, Performance Effort, and Frustration; the Borg Rating of Perceived Exertion (RPE) Scale, which assesses how hard participants perceive their body to be working on a scale from 6 to 20; and the User Evaluation Questionnaire (UEQ) Score, which gauges user experience based on factors like"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation

Trisha Kesar 2022. "Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04013971.