The Clinical Effect of Modified Mirror Therapy in Patients With Upper Limb Hemiparesis After Stroke: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment-Upper Extremity
研究概览
简要总结
This was a randomized controlled study in China conducted during Aug. 2022 to Aug. 2023. Totally, patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine of two hospitals, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy.
详细描述
Upper limb hemiparesis is a motor and sensory disorder that occurs after stroke, with an incidence rate of up to 55% to 75%. Effective upper limb rehabilitation methods help reduce the occurrence of disuse syndrome and complex regional pain syndrome. Therefore, finding active and effective limb rehabilitation methods has important practical significance.This was a randomized controlled study in China conducted during Aug. 2022 to Aug. 2023. Totally, patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine of two hospitals, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy. The assessment was conducted respectively on day 1 and day 30.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria of stroke, by CT or MRI.
- •The first-onset stroke.
- •Presenting with unilateral upper limb dysfunction, within Brunnstrom stage Ⅱ to Ⅳ on the affected side, and Ash-worth score ≤
- •No obvious cognitive impairment, with Mini-Mental State Examination (MMSE) score >21 points.
- •National Institutes of Health Stroke Scale (NIHSS) score >4 points.
- •Stable vital signs, no severe diseases such as cancer, liver or kidney disorders.
- •Aged 35-70 years.
- •Courses of diseases 2-6 weeks.
排除标准
- •Presence of aphasia, apraxia, or hemispatial neglect.
- •Presence of hearing, vision, or comprehension impairments that hinder diagnosis and treatment.
- •Complicate with traumas, fractures, or other progressive neuro-muscular system diseases.
- •Severe spasticity in the upper limbs.
- •Severe bone, joint, or muscle deformities or lesions.
- •History of mental illness.
研究组 & 干预措施
modified mirror therapy+Modified mirror therapy
The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy.
干预措施: Routine treatment (Behavioral)
modified mirror therapy+Modified mirror therapy
The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy.
干预措施: Rehabilitation training (Behavioral)
modified mirror therapy+Modified mirror therapy
The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy.
干预措施: Modified mirror therapy (Behavioral)
routine rehabilitation therapy
The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy.
干预措施: Routine treatment (Behavioral)
routine rehabilitation therapy
The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy.
干预措施: Rehabilitation training (Behavioral)
结局指标
主要结局
Fugl-Meyer Assessment-Upper Extremity
时间窗: day 1 and day 30
The Fugl-Meyer Assessment-Upper Extremity was used to evaluate the patient's upper limb function and motor control. It included the assessment of movements in the shoulder, elbow joint, wrist, and fingers. During the assessment, the assessor observed and recorded the patient's abilities and limitations in specific actions. Based on the patient's performance in each sub-item, the assessor assigned a score using a 0-2 scale, a score of 0 indicating inability to perform, 1 indicating partial ability, and 2 indicating full ability. Finally, the scores for each sub-item were summed up to obtain an overall upper limb function score of 0-66, with scores positively correlated with the upper limb function.
次要结局
- Anxiety(day 1 and day 30)
- Visual Analog Scale(day 1 and day 30)
- the coordinated contraction rate-Surface electromyography-The triceps brachii(day 1 and day 30)
- the coordinated contraction rate-Surface electromyography-The biceps brachii(day 1 and day 30)
- Depression(day 1 and day 30)
研究者
Zeng Changhao
PI
People's Hospital of Zhengzhou University