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临床试验/NCT06503484
NCT06503484招募中不适用

Utilizing a Brain-Computer Interface for Observational Imitation Training to Enhance Upper Limb Motor Recovery Post-Stroke: A Randomized Controlled Trial

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
44
试验地点
2
主要终点
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE)

研究概览

简要总结

Objectives: 1) To compare the effects of closed-loop brain-computer interface (BCI) driven observational imitation training versus sham BCI open-loop observational imitation training on improving upper limb motor functions in patients with stroke; 2) To investigate whether stroke patients receiving closed-loop training exhibit higher activation levels in the mirror neurons, measured by event-related desynchronization (ERD), compared to those receiving open-loop training.

Hypothesis to be tested: The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes, and there is an increase in the mirror neurons activity in those receiving closed-loop training.

Design and subjects: A randomized controlled trial with 44 participants with stroke.

Study instruments: Functional near-infrared spectroscopy (fNIRS)-based BCI and electroencephalography (EEG).

Interventions: In the BCI training, participants will engage in kinesthetic motor imagery. When the M1 activation level recorded by fNIRS surpasses a predefined threshold, participants will receive visual feedback to guide them to imitate the movement. However, for participants in the sham BCI group, the visual feedback will be given will be given constantly. Both types of training consist of ten sessions.

Main outcome measures: Upper limb motor tests and the activity of mirror neurons measured by sensorimotor ERD using EEG.

Data analysis: Analysis of variance and correlation. Expected results: The closed-loop BCI-driven observational imitation training is more effective than sham BCI open-loop training on enhancing hemiplegic upper limb functions and the activation of the mirror neurons in patients after stroke.

详细描述

Objectives: 1) To compare the effects of closed-loop brain-computer interface (BCI) driven observational imitation training versus sham BCI open-loop observational imitation training on improving upper limb motor functions in patients with stroke; 2) To investigate whether stroke patients receiving closed-loop training exhibit higher activation levels in the mirror neurons, measured by event-related desynchronization (ERD), compared to those receiving open-loop training.

Hypothesis to be tested: The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes, and there is an increase in the mirror neurons activity in those receiving closed-loop training.

Design and subjects: A randomized controlled trial with 44 participants with stroke.

Study instruments: Functional near-infrared spectroscopy (fNIRS)-based BCI and electroencephalography (EEG).

Interventions: In the BCI training, participants will engage in kinesthetic motor imagery. When the M1 activation level recorded by fNIRS surpasses a predefined threshold, participants will receive visual feedback to guide them to imitate the movement. However, for participants in the sham BCI group, the visual feedback will be given constantly. Both types of training consist of ten sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 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

The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE)

时间窗: At one-month

The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) evaluates upper limb motor impairment post-stroke. It assesses the movement, coordination, and reflex actions of the hemiplegic upper limb. The total scores are 66.

次要结局

  • The Action Research Arm Test (ARAT)(At one-month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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