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临床试验/NCT02776306
NCT02776306已完成不适用

Effects of Mirror Box Therapy on Neuroplasticity and Functional Outcome in Hemiparetic Upper Limb Post Stroke

Mid and South Essex NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in brain connectivity will be assessed by resting-state fMRI

研究概览

简要总结

The purpose of this study is to evaluate the effects of mirror box therapy on upper extremity, motor recovery and motor functioning in patients that have suffered a stroke.

详细描述

Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors, with 30%-60% of patients being unable to fully recover functional use of their upper limbs. As recovery may be due to insufficient or inadequate therapeutic interventions, the progress and evaluation of upper limb treatment is currently being investigated.

Mirror Box therapy is a task orientated, non-invasive, economic and patient directed therapy for hemiparetic upper limb post stroke patients. The study is intended to evaluate cerebral reorganization by using mirror therapy. Movements of the stronger limb trick the brain into thinking that the weaker arm is moving and to stimulate the respective brain areas.

Patients are enrolled into two groups using standard upper limb rehabilitation for three weeks followed by standard rehabilitation plus Mirror Box for another three weeks (Group 1). Group 2 will receive the same therapy in inverted order.

Patients will receive clinical and functional assessment at baseline, three weeks and six weeks including brain MRI using functional resting state MRI.

The primary outcome is functional connectivity (correlation coefficient) at baseline and after treatment. Secondary endpoints include motor and functional recovery using outcome measures like Fugl Meyer assessment, Action Research Arm Test, grip and pincer strength. Further secondary endpoints are increase in sensorimotor cortex activation across the period of therapy and cortical reorganization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18yrs to 105yrs
  • Hemiparetic upper limb post stroke
  • Capable of providing informed consent
  • Intact vision: if diagnosis of peripheral field defect, patient should be able to compensate for it.

排除标准

  • Any contraindication to MRI scanning
  • Clinically significant psychiatric disorder (e.g. depression)
  • Pre-existing neurological or psychiatric disease that could confound the study results.

结局指标

主要结局

Change in brain connectivity will be assessed by resting-state fMRI

时间窗: Baseline, 3 weeks and at 6 weeks

次要结局

  • Activity of daily living will be assessed with Barthel index.(Baseline, 3 weeks and at 6 weeks)
  • Function of the affected hemiplegic upper limb will be assessed with action research arm test(Baseline, 3 weeks and at 6 weeks)
  • Grip strength will be assessed using hand dynamometer(Baseline, 3 weeks and at 6 weeks)
  • Impairment in the hemiplegic upper limb will be assessed with Fugl Meyer test.(Baseline, 3 weeks and at 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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