Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 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
- 是
入选标准
- •for Post-Stroke Participants:
- •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
排除标准
- •for Post-Stroke Participants:
- •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
- •Inclusion Criteria for Able-bodied Participants:
- •age 18 to 90 years
- •no history of neurologic disease
- •no history of orthopedic disease or injury affecting the lower extremity
- •Exclusion Criteria for Able-bodied Participants:
- •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
研究组 & 干预措施
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.
干预措施: AGRF Biofeedback Game (Other)
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.
干预措施: Traditional Biofeedback Interface (Other)
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.
干预措施: Control Condition (Other)
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.
干预措施: AGRF Biofeedback Game (Other)
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.
干预措施: Traditional Biofeedback Interface (Other)
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.
干预措施: Control Condition (Other)
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
Trisha Kesar
Associate Professor
Emory University
