Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation

NCT04013971 | Completed Results

• 2 other identifiers: IRB001068661R21HD095138-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 randomization. Participants will be exposed to 2 types of biofeedback interfaces:

• newly developed game-based interface (projector screen display)
• traditional, non-game interface

Conditions

Gait, Hemiplegic; Stroke

Keywords

stroke; gait rehabilitation; game

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Likert Enjoyment/Boredom Scale Domain Scores

  Day 1, after each of the biofeedback interface sessions

• NASA Task Load Index (NASA - TLX)

  Day 1, after each of the biofeedback interface sessions

• Borg Rating of Perceived Exertion (RPE) Scale

  Day 1, during each of the biofeedback interface sessions

• User Evaluation Questionnaire (UEQ) Score

  Day 1, after each of the biofeedback sessions

Other Outcomes (3)

• Qualitative Feedback

  Day 1, after each of the biofeedback sessions

• Heart Rate

  Day 1, during and after each of the biofeedback sessions

• Skin Impedance

  Day 1, during each of the biofeedback sessions

Study Arms (2)

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.

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.

Other: AGRF Biofeedback Game; Other: Traditional Biofeedback Interface; Other: Control Condition

Interventions

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.

Also known as: gait training bout

Able-bodied Participants; Post-stroke Participants

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.

Also known as: gait training

Able-bodied Participants; Post-stroke Participants

Control Condition OTHER

Participants will complete a control walk with out feedback.

Able-bodied Participants; Post-stroke Participants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• age 18 to 90 years
• no history of neurologic disease
• no history of orthopedic disease or injury affecting the lower extremity
• 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

Sponsors & Collaborators

• Emory University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Emory Rehabilitation Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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.

  PMID: 41510277 DERIVED

MeSH Terms

Conditions

Gait Disorders, Neurologic; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Trisha Kesar, PT, PhD
• Organization: Emory University

tkesar@emory.edu

404-712-5803

Study Officials

• Trisha Kesar, PT, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: April 4, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 25, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Individual participant data will be available for sharing beginning 9 months and ending 36 months after the article publication.
• Access Criteria: 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.

Locations

US (1)