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临床试验/NCT03614195
NCT03614195已完成不适用

Immediate and Retained Effects of Three Types of Dual-task Interventions on Dual-task Walking Performance of Stroke Patients: Psychometric Study and Randomized Controlled Trial

Chang Gung University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年10月24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
54
试验地点
1
主要终点
gait speed

研究概览

简要总结

The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of three types of dual-task balance interventions on dual-task walking for stroke patients.

详细描述

English Synopsis

I. Title of Study:

Immediate and retained effects of three types of dual-task interventions on dual-task walking performance of stroke patients: psychometric study and randomized controlled trial

II. Study Objectives:

The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of three types of dual-task balance interventions on dual-task walking for stroke patients. Specifically, we will investigate psychometric properties (i.e. reliability, validity, and responsiveness) of dual-task walking assessments with various levels of difficulty for stroke individuals (Aim 1). The second aim of this study is to compare the immediate and retained effects of combined motor and cognitive dual-task training (MCDTT), motor dual-task training (MDTT), and cognitive dual-task training (CDTT) on dual-task gait and cognitive performance after stroke (Aim 2). The third aim of this study is to elucidate the changed CMI pattern of stroke patients after dual-task interventions (Aim 3).

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

入选标准

  • •(1) first-ever stroke with onset duration more than 3 months
  • •(2) able to walk 10 m
  • •(3) no severe vision, hearing, and language problems.

排除标准

  • •orthopedic and other neurological disorders that affect walking
  • •other treatments that could influence the effects of the interventions (e.g., recent Botulin toxin treatment of the lower extremity)
  • •moderate or severe cognitive impairments (score < 24 on Mini-Mental State Examination)
  • •severe uncorrected visual deficits.

研究组 & 干预措施

MCDTT

Experimental

The MCDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks.

干预措施: MCDTT (Device)

MDTT

Active Comparator

The MDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks.

干预措施: MDTT (Device)

CDTT

Active Comparator

The CDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks.

干预措施: CDTT (Device)

结局指标

主要结局

gait speed

时间窗: 10 minutes

Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch. The primary gait parameter is gait speed (cm/s) under dual-task walking conditions using the 10 Meter Walking Test.

composite score

时间窗: 10 minutes

For all the cognitive tasks, we will calculate a composite score for cognitive-task performance by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs in the overall dual-task effect.

次要结局

  • Berg Balance Scale (BBS).(5-10 minutes)
  • Chair Stand Test (CS).(2 minutes)
  • Patient Global Impression of Change Scale (PGIC).(1 minutes)
  • Muscle Strength of Lower-Extremity.(10 minutes)
  • Mini-Balance Evaluation Systems Test (Mini-BESTest).(10 minutes)
  • Functional Gait Assessment (FGA).(10 minutes)
  • Timed Up and Go Test (TUG)(2 minutes)
  • Activity-specific Balance Confidence Scale (ABC).(2 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Li-Ling Chuang

Assistant Professor

Chang Gung University

研究点 (1)

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