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临床试验/NCT03854487
NCT03854487已完成不适用

Effect of Mirror Therapy on Unilateral Neglect for Patients After Stroke

The Hong Kong Polytechnic University0 个研究点目标入组 21 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
主要终点
Unilateral neglect

研究概览

简要总结

This is a single-blinded randomized controlled trial to investigate the effects of mirror therapy (MT), with reference to sham mirror (a glass wall) and control (a covered mirror), in reducing unilateral neglect for patients with stroke in 2 centres.

详细描述

Twenty-one subacute inpatients with left unilateral neglect after right-hemispheric stroke, recruited from 2 hospitals - Hong Kong and Guangzhou, in 1 and a half years, were randomly assigned to three groups; mirror therapy, sham therapy (in the form of a transparent glass wall), and control (covered mirror). The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks) movement practice for the hemiplegic arm involved 5 table-top tasks graded according to the severity of patients' arm impairments. Blinded assessments were administered at baseline, 3-week postintervention, and 3-week follow-up upon completion of training.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ischemic or hemorrhagic stroke, confirmed by medical diagnoses compatible with a unilateral right lesion involvement (i.e. left hemiplegic), exhibited left visual field inattention or unilateral neglect by obtaining a total score of star cancellation subtest in the conventional battery of the Behavioural Inattention Test ≤ 51 (out of 54);
  • stroke with onset of neurological condition ≤ 6 months previously;
  • have normal or corrected-to-normal visual acuity better than 20/60 (6/18) in the better eye;
  • with hemiplegic upper extremity functional levels 3-7 as rated by Functional Test for the Hemiplegic Upper Extremity and is able to move against gravity;
  • ability to understand and follow simple verbal instructions, with Mini-mental State Examination ≥ 21;
  • ability to participate in a therapy session lasting at least 30 minutes;
  • consent to participant in the study

排除标准

  • prior neurological or psychiatric disorders;
  • severe spasticity (Modified Ashworth Scale >3) over paretic arm;
  • history of recent Botox injection or acupuncture to the paretic arm within the past three months;
  • participation in another clinical study elsewhere apart from the study site during recruitment

研究组 & 干预措施

Mirror therapy

Experimental

干预措施: Mirror therapy (Behavioral)

Sham mirror

Sham Comparator

干预措施: Sham mirror (Behavioral)

Covered mirror

Active Comparator

干预措施: Covered mirror (Behavioral)

结局指标

主要结局

Unilateral neglect

时间窗: Change of baseline to 3-week and to follow-up at 6-week

Behavioural Inattention Test

Allocentric and egocentric neglect

时间窗: Change of baseline to 3-week and to follow-up at 6-week

Gap Detection Test

Functional performance related to unilateral neglect

时间窗: Change of baseline to 3-week and to follow-up at 6-week

Catherine Bergego Scale

次要结局

  • Upper limb functions(Change of baseline to 3-week and to follow-up at 6-week)

研究者

申办方类型
Other
责任方
Sponsor

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