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临床试验/NCT06285175
NCT06285175已完成不适用

REINVENT: A Brain and Muscle Computer Interface for People With Severe Stroke

University of Southern California2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年6月1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
14
试验地点
2
主要终点
Fugl Meyer Assessment - Upper Extremity

研究概览

简要总结

Stroke is a leading cause of adult disability in the United States. High doses of repeated task-specific practice have shown promising results in restoring upper limb function in chronic stroke (>6 months after onset). However, it is currently challenging to provide such doses in standard clinical practice. At-home telerehabilitation services supervised by a clinician are a potential solution to provide higher-dose interventions. However, telerehabilitation systems developed for repeated task-specific practice typically require a minimum level of active movement. Therefore, severely impaired people necessitate alternative therapeutic approaches. Measurement and feedback of electrical muscle activity via electromyography (EMG) have been previously implemented in the presence of minimal or no volitional movement to improve motor performance in people with stroke. Specifically, muscle neurofeedback training to reduce unintended co-contractions of the impaired hand may be a targeted intervention to improve motor control in severely impaired populations. In this study, we examine the effects of a low-cost, portable, and modular EMG biofeedback system (Tele-REINVENT) for supervised and unsupervised upper limb telerehabilitation after stroke during a 6-week home-based training program that reinforces activity of the wrist extensor muscles while avoiding coactivation of flexor muscles via computer games.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate to severe upper extremity hemiparesis and residual hand function (e.g., less than 20 degrees of active wrist or finger extension and enough muscle activity to measure with electromyography).

排除标准

  • Taking anti-spasticity medication
  • Significant vision loss (corrected vision is acceptable)
  • Receptive aphasia
  • Hand contractures
  • Secondary neurological disease

结局指标

主要结局

Fugl Meyer Assessment - Upper Extremity

时间窗: Through study completion, an average of 1 month

This assessment measures upper limb impairment after stroke

Corticomuscular coherence

时间窗: Through study completion, an average of 1 month

This assessment measures the connectivity between the brain and muscles of the affected side as a percentage.

Maximum EMG activity

时间窗: Through study completion, an average of 1 month

This assessment measures trace muscle activity in the affected limb during a controlled movement task

次要结局

未报告次要终点

研究者

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

Sook-Lei Liew

Associate Professor

University of Southern California

研究点 (2)

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