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临床试验/NCT04013971
NCT04013971已完成不适用

Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation

Emory University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Peak AGRF

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Peak AGRF

时间窗: After each biofeedback interface session on Day 1

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.

Trailing Limb Angle (TLA)

时间窗: After each biofeedback interface session on Day 1

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Trisha Kesar

Associate Professor

Emory University

研究点 (2)

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