Voice-Induced Motor Intention to Enhance Upper Limb Rehabilitation Efficacy of Exoskeleton Robots for Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
研究概览
简要总结
This study aims to investigate whether combining "motor imagery" (the mental visualization of movement) with robotic exoskeleton therapy can improve upper limb recovery in stroke patients. Conventional robotic therapy often involves passive movement driven by the machine. In this study, patients in the experimental group will use their own voice to trigger the robot (e.g., saying "bend arm") while simultaneously imagining the movement. The research will compare this voice-enhanced "active" approach with traditional passive robotic training to see if it better promotes brain-to-muscle signal recovery and improves overall arm function .
详细描述
Background and Rationale: Stroke is a leading cause of adult disability, and the "golden period" for rehabilitation requires intensive therapy to trigger muscle movement. Recent theories suggest that combining motor imagery with physical activity-known as Brain-Computer Interface (BCI) concepts-may be more effective than passive movement alone. However, complex EEG-based BCI is difficult to implement clinically. This study proposes a simplified "voice-controlled" interface to simulate the motor intent-to-action loop.
Study Design: This is a randomized, assessor-blinded, parallel-group clinical trial involving 32 subacute or chronic stroke patients. Participants will be randomly assigned to one of two groups for a 4-week intervention (5 sessions per week, 30 minutes per session).
Interventions:
Experimental Group (Voice + Exoskeleton): Patients will use the Nimbo single-joint robot. Before each movement, they will focus on imagining the target action for 2 seconds, then issue a standardized voice command (e.g., "bend hand") to trigger the robotic assistance.
Control Group (Passive Exoskeleton): Patients will receive conventional robotic-assisted training where the Nimbo exoskeleton moves the limb through a preset path without voice prompts or intentional imagery requirements.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke diagnosed by CT or MRI
- •Stroke onset occurred at least 1 month prior to enrollment
- •Aged 20 to 80 years
- •Moderate to severe upper limb impairment (Fugl-Meyer Assessment-Upper Extremity score between 13 and 47)
- •Cognitive function sufficient to follow instructions (MMSE score > 20)
- •Stable medical condition with no severe pain in the affected upper limb
排除标准
- •Severe spasticity of the affected upper limb (Modified Ashworth Scale score > 2)
- •History of other neurological diseases (e.g., Parkinson's disease, brain tumor)
- •Serious orthopedic conditions or skin lesions on the affected upper limb that prevent robot use
- •Unstable epilepsy or severe psychiatric disorders
- •Pregnancy
研究组 & 干预措施
Voice-Enhanced Motor Imagery Group
Participants in this group receive upper limb rehabilitation using the Nimbo single-joint robot combined with an "Active Imagery" protocol. Before each movement, patients focus on imagining the target action for 2 seconds and then issue a standardized voice command (e.g., "bend hand") to trigger the robotic assistance. The training is conducted for 30 minutes per session, 5 sessions per week, for a total of 4 weeks.
干预措施: single-joint robot (Passive Mode) (Device)
Passive Robotic Training Group
Participants in this group receive conventional passive robotic-assisted rehabilitation using the Nimbo single-joint robot. The robot moves the patient's limb through a preset range of motion automatically. There is no requirement for synchronized motor imagery or voice commands during the session. The training frequency and duration are identical to the experimental group: 30 minutes per session, 5 sessions per week, for 4 weeks.
干预措施: single-joint robot (Active Voice-Controlled Mode) (Device)
结局指标
主要结局
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
时间窗: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
A quantitative measure of upper limb motor recovery. The scale includes 33 items assessing reflexes, movement patterns, and coordination. Scores range from 0 to 66, with higher scores indicating better motor function.
次要结局
- Brunnstrom Recovery Stage (Upper Limb)(Baseline (T0), 2 weeks (T1), and 4 weeks (T2).)
- Kinesthetic and Visual Imagery Questionnaire (KVIQ-10)(Baseline (T0), 2 weeks (T1), and 4 weeks (T2).)
- Laterality Judgment Task (LJT) - Accuracy and Reaction Time(Baseline (T0), 2 weeks (T1), and 4 weeks (T2).)
- Sense of Agency (SoA) Questionnaire(Baseline (T0), 2 weeks (T1), and 4 weeks (T2).)
- System Usability Scale (SUS)(4 weeks (T2).)