Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation

NCT ID: NCT04013971

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2023-03-31

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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

AGRF Biofeedback Game

Intervention Type: 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.

Traditional Biofeedback Interface

Intervention Type: 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.

Control Condition

Intervention Type: OTHER

Participants will complete a control walk with out feedback.

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.

Group Type: OTHER

AGRF Biofeedback Game

Intervention Type: 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.

Traditional Biofeedback Interface

Intervention Type: 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.

Control Condition

Intervention Type: OTHER

Participants will complete a control walk with out feedback.

Interventions

AGRF Biofeedback Game

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.

Intervention Type: 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 4 minutes.

Intervention Type: OTHER

Control Condition

Participants will complete a control walk with out feedback.

Intervention Type: OTHER

Other Intervention Names

gait training bout; gait training

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Trisha Kesar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trisha Kesar, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Rehabilitation Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21HD095138-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00106866

Identifier Type: -

Identifier Source: org_study_id