NCT04013971

Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.
OTHER	Control Condition	Participants will complete a control walk with out feedback.

Timeline

• Start date: 2022-04-04
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2019-07-10
• Last updated: 2025-04-25
• Results posted: 2025-03-26

Locations

1 site across 1 country: United States