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临床试验/NCT02364232
NCT02364232已完成不适用

Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Mini-Mental State Exam, MMSE

研究概览

简要总结

The purpose of this study was to compare the treatment effects of home-based or clinic-based bilateral training with and without mirror feedback programon on physiological markers, sensorimotor, cognition, daily functions, and participation among patients with chronic stroke.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The most recent stroke was between 1 month and 5 years
  • No serious cognitive impairment (MMSE≥21)
  • FMA score =18-62
  • No serious muscle spasticity in shoulder, elbow, wrist and finger (MAS≤3)
  • Modified rankin Scale=2 to 4

排除标准

  • Aphasia that might interfere with understanding instructions
  • Stroke in areas other than the brain and brainstem, such as the cerebellum
  • other neurological disease, such as dementia
  • Muscle and joint have serious pain and inflammatory swelling in affected side.
  • Cannot control hypertension, heart disease and serious throbosis

结局指标

主要结局

Mini-Mental State Exam, MMSE

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

Wolf Motor Function Test, WMFT

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

Chedoke Arm and Hand Activity Inventory

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

Motor Activity Log, MAL

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

Lawton-Brody IADL Scale

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

10-Meter Walking Test, 10MWT

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

Actigraphy

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

The World Health Organization Quality of Life -Brief version, WHOQOL-BRE

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

6 minute walk test

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

Pittsburg Sleep Quality Index

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

pinch and grasp dynamometer

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

Box and Block Test, BBT

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

ABILHAND Questionnaire

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

Medical Research Council scale,MRC

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

Fugl-Myer Assessment, FMA

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

Revised Nottingham Sensory Assessment

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

Modified Ashworth Scale, MAS

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

Canadian Occupational Performance Measure, COPM

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention

Nottingham Extended Activities of Daily Living, NEADL

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

Stroke Impact Scale, SIS

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

The Euroqol Quality of Life Scale

时间窗: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

次要结局

  • Montreal Cognitive Assessment, MoCA(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Minnesota Rate of Manipulation Test during dual Task(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • BDI-II,Beck Depression Inventory II(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Modified Rankin Scale, mRS(baseline)
  • 30 second sit-to-stand test(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Timed up and go test(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Stroop Test(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • The stroke self-efficacy questionnaire(Change from baseline up to 4 weeks immediately after the completion of intervention)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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