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Determinants and Practical Significance of Change in Motor Ability, Functional Performance, and HRQOL After Stroke

2008年10月20日 更新者:National Taiwan University Hospital

Determinants and Practical Significance of Change in Motor Ability, Functional Performance, and HRQOL After Distributed Constraint-Induced Therapy in Stroke

This study has two purposes. First, the investigators will identify determinants of changes in motor ability, activities of daily living, and HRQOL after distributed Constraint-induced therapy for patients with stroke with the Chi-squared Automatic Interaction Detector (CHAID) analysis. The results will help target which types/characteristics of patients will benefit most from the intervention and may identify different determinants across different levels of outcomes. Secondly, in order to understand the extent of treatment effect in terms of clinical relevance, the investigators will examine whether the change scores on measures of motor ability, activities of daily living, and HRQOL after distributed CIT reach clinically important differences or not.

研究概览

地位

未知

详细说明

Stroke is a major cause of long-term disability in many countries. More than 50% of stroke survivors experience resultant upper extremity (UE) movement impairments that lead to activity limitations and restriction of participation. Various contemporary rehabilitation strategies which aim to improve UE motor deficits after stroke have been proposed. Constraint-induced therapy (CIT) is one of the current promising approaches, and numerous CIT and distributed CIT studies have shown substantial evidence of positive treatment effects.

Although studies have shown a form of distributed CIT can enhance motor function of the affected UE, functional performance, and some aspects of HRQOL post stroke, determinants related to distributed CIT outcomes remain unclear. In addition, mismatch between the statistically significant and clinically important differences (CID) for change scores has been identified as a limitation of CIT studies. Investigation of CID is critical for understanding the clinically relevant meanings of change scores after intervention. Therefore, the purposes of this project are to (1) identify determinants of changes in motor ability, functional performance, and HRQOL after distributed CIT for patients with stroke using the Chi-squared Automatic Interaction Detector analysis; (2) examine whether the change scores on outcome measures after distributed CIT reach CID.

Within the one year, we plan to complete cumulated data of distributed CIT trials for 70 subjects. The distributed CIT intervention will be provided by two certified occupational therapists. The Fugl-Meyer Assessment (FMA), Wolf Motor Function Test (WMFT), Functional Independence Measure (FIM), and Stroke Impact Scale (SIS) will be used as outcome measures in this project. Six potential predictors will be selected for the FMA, WMFT and FIM, and seven potential predictors will be selected for the SIS based on previous empirical findings and theoretical basis. CHAID analysis will be used to identify the specific determinants and the best split points of the determinants. In addition, based on Cohen's effect size benchmark, if the change scores on the FMA, WMFT, FIM and SIS exceeded 0.2SD will be considered as CID.

After the one-year project, we will identify the determinants of motor ability, functional performance, and HRQOL after distributed CIT and thus can help understand the factors that may affect treatment outcomes and target patients who benefit most from this intervention. Additionally, we will provide the results of CID for better evaluation and interpretation of the change scores after distributed CIT.

研究类型

观察性的

注册 (预期的)

70

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

      • Taipei、台湾
        • National Taiwan University 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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

a group of stroke patients

描述

Inclusion Criteria:

  • A first-ever unilateral stroke onset at least 6 months previously
  • Demonstration of Brunnstrom stage > III for the proximal part of UE
  • Considerable nonuse of the more affected upper extremity (MAL amount of use score < 2.5);5
  • No balance problems sufficient to compromise safety when wearing the constraint mitt
  • Willing to provide written informed consent.

Exclusion Criteria:

  • To avoid the confounding effects of cognitive and medical conditions, potential subjects will be excluded if the medical or physical screening exam reveals a score of less than 24 on the Mini Mental State Exam
  • 32 physician-determined major medical problems or poor physical conditions that would interfere with participation
  • Excessive pain in any joint that might limit participation.

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

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。

调查人员

  • 研究主任:Keh-chung Lin, ScD, OTR、Occupational Therapy Services, National Taiwan University 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

2008年7月1日

初级完成 (预期的)

2009年6月1日

研究完成 (预期的)

2009年6月1日

研究注册日期

首次提交

2008年10月19日

首先提交符合 QC 标准的

2008年10月20日

首次发布 (估计)

2008年10月21日

研究记录更新

最后更新发布 (估计)

2008年10月21日

上次提交的符合 QC 标准的更新

2008年10月20日

最后验证

2008年7月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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