Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation

Not Applicable

Completed

• Conditions: Gait, Hemiplegic; Stroke
• Interventions: Other: AGRF Biofeedback Game; Other: Optional Game with VR; Other: Traditional Biofeedback Interface; Other: Control Condition

• Registration Number: NCT04013971
• Lead Sponsor: Emory University

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. In a separate session, some participants may complete preliminary or exploratory testing of the virtual reality (VR) version of the biofeedback game (head-mounted augmented reality (AR) or VR display), which will be used to determine feasibility and preliminary effects of VR-based feedback on gait.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Study Start: 2022-04-04
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AGRF Biofeedback Game Followed by the Traditional biofeedback Interface	AGRF Biofeedback Game	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.
Traditional biofeedback Interface Followed by the AGRF Biofeedback Game	Control Condition	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.
AGRF Biofeedback Game Followed by the Traditional biofeedback Interface	Traditional Biofeedback Interface	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.
Optional Game with VR	Optional Game with VR	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.
AGRF Biofeedback Game Followed by the Traditional biofeedback Interface	Control Condition	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.
Traditional biofeedback Interface Followed by the AGRF Biofeedback Game	AGRF Biofeedback Game	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.
Traditional biofeedback Interface Followed by the AGRF Biofeedback Game	Traditional Biofeedback Interface	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.

Primary Outcome Measures

Name	Time	Method
Peak AGRF	After each biofeedback interface session on Day 1	Paretic leg or targeted leg peak push off force (peak AGRF) will be calculated from GRF data. The success of the targeted training task will be assessed as the percentage of steps for which the target paretic AGRF was achieved.
Trailing Limb Angle	After each biofeedback interface session on Day 1	The trailing limb angle contributes to increased propulsion during walking. In stroke survivors, trailing limb angle increases as walking speed increases.

Secondary Outcome Measures

Name	Time	Method
Borg Rating of Perceived Exertion (RPE) Scale	Day 1, during each of the biofeedback interface sessions	The Borg Rating of Perceived Exertion (RPE) Scale asks respondents to report how hard it feels like their body is working. 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.
NASA Task Load Index (NASA - TLX)	Day 1, after each of the biofeedback interface sessions	The NASA task load index (NASA - TLX) evaluates user reports of perceived effort in five different domains:Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each domain is scored on a 21-point scale from 1 to 21, where very low demand/perfect performance = 1 and very high demand/failure = 21.
User Evaluation Questionnaire (UEQ) Score	Day 1, after each of the biofeedback sessions	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 6 = the most agreement with the adjective on the right.
Likert Enjoyment/Boredom Scale Scores	Day 1, after each of the biofeedback interface sessions	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. Each domain 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.

Trial Locations

Locations (1)

Emory Rehabilitation Hospital; 🇺🇸 Atlanta, Georgia, United States