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Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke

2017年2月5日 更新者：Chang Gung Memorial Hospital

Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke: a Randomized Controlled Trial

The specific aims of this study will be:

  1. To compare the immediate and retention treatment effects of the patients receiving home-based mirror therapy combined with task-oriented training (MTOT) with a hospital-based MTOT group and a hospital conventional rehabilitation group on different aspects of outcomes.
  2. To examine the feasibility, satisfaction, and safety of this novel home-based MTOT program.
  3. To investigate the factors that may affect the efficacy of home-based stroke rehabilitation.

研究概览

地位

完全的

条件

干预/治疗

详细说明

In this 3-year study project, we will design a single-blind randomized controlled trial (1) to compare the treatment effects of home-based MTOT with a hospital-based MTOT group and a hospital conventional rehabilitation group, (2) to investigate the feasibility, satisfaction, and safety of this home-based program, and (3) to identify the factors that might influence treatment outcomes. An estimated total of 90 patients with stroke will be recruited in this study. All participants will be randomly assigned to receive home-based MTOT or hospital-based rehabilitation for a 4-week training period (a total of 12 sessions). Before the first treatment session, a client-centered questionnaire will be administered to each patient for identifying individual needs and goals. Feasibility evaluation and caregiver's wellbeing will be also assessed. Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up.

研究类型

介入性

注册 (实际的)

3

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 台湾
      • Kaohsiung、台湾
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei、台湾
        • Taipei Chang Gung Memorial Hospital
      • Taoyuan、台湾
        • Taoyuan Chang Gung Memorial Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • diagnosed as having a unilateral stroke
  • at least 3 months after stroke onset
  • from 20 to 80 years of age
  • having completed acute rehabilitation care or discharged home
  • a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
  • able to follow the therapy instructions (cognition status will be measured by the Montreal Cognitive Assessment)
  • capable of participating in therapy and assessment sessions.

Exclusion Criteria:

  • neglect
  • global or receptive aphasia
  • major medical problems
  • comorbidities that influenced UE usage or caused severe pain

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：home-based MTOT
Home-based mirror therapy combined with task-oriented training (MTOT)
行为的：home-based MTOT
The home-based MTOT group will receive 30 minutes of MT followed by 30 minutes of TOT per session. The intervention will take place in the participant's home environment. During the mirror practices, the patient will seat close to a table which the mirror box will be placed at the mid-sagittal plane. During MT, the participant will be encouraged to actively move their paretic arm and hand concurrently with the mirror reflection of the movement of the nonparetic arm and hand as possible as they can. If necessary, the therapist will assist the participant in moving the paretic hand to synchronize the movement with the nonparetic hand.
有源比较器：hospital-based therapy
hospital-based individualized occupational therapy
行为的：hospital-based therapy
The control group will receive a dose-matched, individualized occupational therapy at a hospital. The participants will receive customary rehabilitation programs as usual performed at hospitals for 1 hour per session. The treatment protocol will include: (a) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques, (b) fine motor or dexterity training, (c) arm exercises or gross motor training, (d) muscle strengthening of the affected upper limb, and (e) activities of daily living training or functional task practice.
实验性的：hospital-based MTOT
hospital-based mirror therapy combined with task-oriented training (MTOT)
行为的：hospital-based MTOT
The hospital-based MTOT group will also receive 30 minutes of MT followed by 30 minutes of TOT per session at a hospital. The intervention will take place in the occupational therapy clinic. The treatment modalities in the hospital will be selected and provided for this group. Most of the treatment principles and components are the same as aforementioned in the home-based MTOT. However, the major differences between home-based and hospital-based MTOT are the treatment contexts, environments and functional modalities used.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change scores of Fugl-Meyer Assessment (FMA)
大体时间：baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Modified Rankin Scale (mRS)
大体时间：baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months

次要结果测量

结果测量
大体时间
Change scores of Box and Block Test (BBT)
大体时间：baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of grip and pinch power
大体时间：baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Revised Nottingham Sensory Assessment (RNSA)
大体时间：baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Barthel Index (BI)
大体时间：baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Activity monitors (ActiGraph)
大体时间：baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Stroke Impact Scale (SIS) Version 3.0
大体时间：baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Motor Activities Log (MAL)
大体时间：baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
大体时间：baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months

其他结果措施

结果测量
措施说明
大体时间
World Health Organization Quality of Life (WHOQOL)-BREF
大体时间：baseline, 4 weeks
for caregiver evaluation
baseline, 4 weeks
satisfaction questionnaire
大体时间：baseline, 4 weeks
baseline, 4 weeks
patient-reported fatigue and pain ratings
大体时间：baseline, 4 weeks
baseline, 4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chang Gung Memorial Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年3月1日

初级完成 (实际的)

2016年11月1日

研究完成 (实际的)

2016年11月1日

研究注册日期

首次提交

2015年4月29日

首先提交符合 QC 标准的

2015年4月29日

首次发布 (估计)

2015年5月4日

研究记录更新

最后更新发布 (估计)

2017年2月7日

上次提交的符合 QC 标准的更新

2017年2月5日

最后验证

2016年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 103-7164A3

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