Neural Mechanisms and Efficacy of Multimodal Sensory Feedback Augmentation on Mirror Therapy for Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
研究概览
简要总结
The goal of this clinical trial is to investigate the clinical and neurophysiological effects of a novel multimodal sensory feedback mirror therapy in stroke survivors with upper extremity hemiparesis , aged between 20 and 85 years.
The main questions it aims to answer are:
- Does Multimodal Augmented Mirror Therapy (MAF-MT) lead to significantly greater improvements in functional recovery compared to unimodal digital mirror visual feedback mirror therapy (MVF-MT) or traditional mirror therapy (TMT) ?
- What are the underlying neurophysiological changes in brain activation (mu rhythm desynchronization) and intermuscular coordination patterns associated with this hybridized feedback approach?
Researchers will compare the MAF-MT group (receiving digital mirror visual feedback with multimodal sensory feedback) to the MVF-MT group (digital mirror feedback only) and the TMT group (traditional mirror therapy using the standard mirror box) to see if the integration of multimodal feedback leads to superior functional and brain acitivity outcomes.
Participants will undergo eligibility screening including assessments of motor impairment and cognitive status. They will participate in 20 sessions of intervention, consisting of approximately 75 minutes of assigned therapies. They will receive specific sensory intervention depending on group assignment and complete evaluation (described in Outcome Measures) before the intervention, immediately after, and at a one-month follow-up
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 3 months post-onset of a unilateral stroke
- •Age between 20 and 85 years
- •An initial Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score between 18 and 56
- •Ability to follow study instructions, as determined by a Montreal Cognitive Assessment (MoCA) score ≥ 18
- •No concurrent participation in other neurorehabilitation studies or drug clinical trials
排除标准
- •Severe neglect, as measured by the line bisection test
- •Uncontrolled major medical conditions, such as uncontrolled hypertension or heart failure, or concomitant neurological conditions, for example, dementia, Parkinson's disease, brain tumors, or other brain conditions
- •Severe pain, swelling, spasticity or contractures in affected arms that prevent movement practice and assessments.
研究组 & 干预措施
MVF-MT: Digital Mirror Visual Feedback Mirror Therapy
干预措施: MVF-MT: Digital Mirror Visual Feedback Mirror Therapy (Behavioral)
TMT: Traditional Mirror Therapy
干预措施: Traditional Mirror Therapy (Behavioral)
MAF-MT: Multimodal Augmented Mirror Therapy
干预措施: MAF-MT: Multimodal Augmeneted Mirror Therapy (Behavioral)
结局指标
主要结局
Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
时间窗: Baseline, 4 weeks, and 8 weeks
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) will be used to evaluate motor impairment through 33 items measuring the movement and reflexes of the shoulder, elbow, forearm, wrist, and hand, as well as coordination and speed. Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), resulting in a maximum total score of 66, where higher scores indicate better motor recovery and lower impairment. This scale is a widely recognized, reliable, and valid tool for assessing motor performance in post-stroke populations.
次要结局
- Wolf Motor Function Test (WMFT)(Baseline, 4 weeks and 8 weeks)
- Modified Ashworth Scale (MAS)(Baseline, 4 weeks and 8 weeks)
- Medical Research Council scale (MRC)(Baseline, 4 weeks and 8 weeks)
- Nottingham Extended Activities of Daily Living Scale (NEADL)(Baseline, 4 weeks and 8 weeks)
- The Lawton-Brody Instrumental Activities of Daily Living Scale (Lawton-Brody IADL)(Baseline, 4 weeks and 8 weeks)
- EQ-5D-5L(Baseline, 4 weeks and 8 weeks)
- Functional Abilities Confidence Scale (FACS)(Baseline, 4 weeks and 8 weeks)
- Stroke Self-Efficacy Questionnaire (SSEQ)(Baseline, 4 weeks and 8 weeks)
- Daily Living Self-Efficacy Scale (DLSES)(Baseline, 4 weeks and 8 weeks)
- Movement Imagery Questionnaire-Revised, Second Edition (MIQ-RS) Chinese version(Baseline, 4 weeks and 8 weeks)
- The Embodiment Questionnaires(Baseline, 4 weeks and 8 weeks)
- Electroencephalography (EEG)-Event-related desynchronization (ERD) of sensorimotor mu rhythm of both hemispheres(Baseline, through study completion, an average of 1 year)
- Electromyography (EMG) - intermuscular coherence (IMC) between both hands(Baseline, through study completion, an average of 1 year)