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临床试验/NCT06301659
NCT06301659已完成不适用

Impact of Adapted Mirror Therapy on Individuals With Hemiparesis of the Upper Limb Following a Stroke: A Randomized Controlled Trial

Ahmadu Bello University Teaching Hospital1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2022年8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
116
试验地点
1
主要终点
Fugl-Meyer Assessment-Upper Extremity

研究概览

简要总结

Patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine, 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. On day 1 and day 30, patients' Upper Limb function were compared.

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%. This was a Randomized controlled trial. Patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine, 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. On day 1 and day 30, patients' Upper Limb function were compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (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

入选标准

  • Meeting the diagnostic criteria of stroke.
  • 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.

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

  • Depression(day 1 and day 30)
  • Anxiety(day 1 and day 30)
  • Visual Analog Scale(day 1 and day 30)
  • coordinated contraction rate-Surface electromyography(day 1 and day 30)

研究者

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

Muhammad

Research Director

Ahmadu Bello University Teaching Hospital

研究点 (1)

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