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临床试验/NCT03234998
NCT03234998已完成不适用

Comparative Efficacy of Two Different Dual-task Balance Interventions on Balance, Gait, and Cognitive Performance Under Single- and Dual-task Conditions in Stroke Patients and Older Adults

Chang Gung University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年8月25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
42
试验地点
1
主要终点
sway index

研究概览

简要总结

The objective of this study is to investigate the effects of two different dual-task balance interventions for stroke patients and older adults.

详细描述

English Synopsis

I. Title of Study:

Comparative efficacy of two different dual-task balance interventions on balance, gait, and cognitive performance under single- and dual-task conditions in stroke patients and older adults

II. Study Objectives:

The objective of this study is to investigate the effects of two different dual-task balance interventions for stroke patients and older adults. Specifically, the investigators will compare the immediate and retention effects of motor and cognitive dual-task balance training [MCDT] and cognitive dual-task balance training [CDT]) on balance, gait, and cognition under single- and dual-task conditions in individuals with stroke (Aim 1) and elderly people (Aim 2). The third aim of this study is to elucidate the mechanisms underlying changes in balance, gait, and cognitive performance of stroke patients and older adults after MCDC and CDT (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
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for Stroke Individuals:
  • •first-ever stroke with onset duration more than 3 months
  • •able to walk 10 m
  • •no severe vision, hearing, and language problems
  • •Inclusion Criteria for Healthy elderly:
  • •more than 65 years old
  • •able to walk 10 m
  • •no neurological or musculoskeletal diagnosis
  • •no severe vision, hearing, cognition, 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 <21 on Mini-Mental State Examination)
  • •severe uncorrected visual deficits

研究组 & 干预措施

motor-cognitive dual-task training

Experimental

Participants in the motor-cognitive dual-task training group will participate in 12-session programs administered for 60 minutes each session, 3 times per week for 4 weeks.

干预措施: motor-cognitive dual-task training (Device)

cognitive dual-task training

Active Comparator

Participants in the cognitive dual-task training group will also participate in a 12-session program conducted 60 minutes per session, 3 days a week, for a total of 4 weeks.

干预措施: cognitive dual-task training (Device)

结局指标

主要结局

sway index

时间窗: 10 minutes

Sway index is the standard deviation of the sway angle. The higher the sway index the more unsteady the person was during the test.

gait speed

时间窗: 5 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 outcome measure will be gait speed (cm/s) under single- and dual-task conditions.

cognitive-motor interference (CMI)

时间窗: 20 minutes

The effect of dual-tasking on both standing/walking and cognitive parameters will be assessed by comparing any change in performance of balance/gait and cognitive measures between single- and dual-task conditions. We will calculate DTE for gait speed and composite score using following formula: \[(Dual-task - Single-task)/ Single-task \*100\] and for sway index using formula: \[(Single-task - Dual-task)/ Single-task \*100\]. Negative cost (higher cost) indicates poor performance on dual-task conditions compared with single-task conditions.

composite score

时间窗: 10 minutes

Participants will be asked to perform six different cognitive tasks while sitting, standing, and walking. The order of six cognitive tasks will be counterbalanced, but will be equal for the single- and dual-task conditions. The six cognitive tasks are selected based upon the different domains of cognitive tasks commonly used in previous dual-task studies. 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

  • Functional Gait Assessment (FGA)(10 minutes)
  • Berg Balance Scale (BBS)(5-10 minutes)
  • Timed Up and Go Test(2minutes)
  • Chair Stand Test.(1 minute)
  • Patient Global Impression of Change Scale (PGIC)(1 minute)
  • Activity-specific Balance Confidence Scale (ABC)(3 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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