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临床试验/NCT04328779
NCT04328779
已完成
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Multi-task Gait Training Mode to Enhance Walking Function, Cognitive Performance, Task Coordination, and Transfer to Community Ambulation in Patients With Chronic Stroke

Chang Gung University1 个研究点 分布在 1 个国家目标入组 68 人2020年8月14日
适应症Stroke

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Stroke
发起方
Chang Gung University
入组人数
68
试验地点
1
主要终点
gait speed
状态
已完成
最后更新
2年前

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 multi-task walking interventions on walking for patients with chronic stroke. Specifically, we will investigate psychometric properties (i.e. reliability, validity, and responsiveness) of dual-task walking assessments with the Stroop task for chronic stroke individuals (Aim 1). The second aim of this study is to compare the effects of multi-task walking training mode to traditional rehabilitation in patients with chronic stroke (Aim 2). The third aim of this study is to compare the immediate, retained, and transfer effect of multi-task overground walking training to multi-task treadmill walking training on walking function, cognitive performance, task coordination, and community ambulation in patients with chronic stroke (Aim 3).

详细描述

Only 7% patients can walk safely in the community. Functional community ambulation requires the ability of walking while performing other tasks. It is emergent to establish dual-task walking assessment with good psychometric properties and to identify the most effective approach that enhances dual-task walking performance for stroke patients. Our ongoing study found that motor tasks combined with cognitive dual-task training (multi-tasking ) have more improvements on cognitive performance of the Stroop task while walking than cognitive dual-task training alone. Therefore, combined motor and cognitive elements to walking training might be considered as a novel therapeutic strategy to promote functional ambulation and recovery of stroke patients. This combined strategy is based on attentional capacity sharing theory and the research advances on dual-task to enhance active participation and cognitive involvement, strengthen dual-task walking ability, then transfer to promote community ambulation and participation. However, lacking prospective, controlled trials quantify gait and cognition under dual-task conditions after multi-task walking training. Specifically, we will investigate psychometric properties of dual-task walking assessments for chronic stroke individuals. The second aim is to compare the immediate, retained, and transfer effects of of multi-task overground walking training to multi-task treadmill walking and traditional rehabilitation on walking function, cognitive performance, task coordination, and community ambulation in patients with chronic stroke. A metric analysis and comparative efficacy research will be conducted. Sixty chronic stroke patients will receive dual-task walking assessments twice at pretreatment with a 1-week interval for test-retest assessment and investigation of the reliability and validity of outcome measures. The primary outcome measure of the dual-task walking assessments will include walking at preferred speed and fast speed and simultaneously perform the Stroop task. Concurrent validity will be studied to validate the dual-task walking measures with each other and with the item 14 of the mini-Balance Evaluation Systems test (Mini-BESTest), dual-task Timed-up-and-Go test (dual-TUG), and 6-min walk test obtain concurrently for assessing dual-task ability. In addition, we will compare dual-task walking performance between fallers and non-fallers to examine discriminant validity of dual-task walking assessments. A comparative efficacy research is a single-blind, randomized controlled trial, which will be conducted at medical centers. Sixty ambulatory stroke patients will be randomized to multi-task overground walking training or multi-task treadmill walking training or traditional rehabilitation. All three groups will receive interventions 3 times a week for 4 weeks. The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks. The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill. Traditional rehabilitation will train strength, balance, and gait. A blinded assessor will administer three assessments All participants will be examined gait and cognitive performance under single-task (walking only, cognitive tasks only) and dual-task conditions (walking while performing the Stroop task) at baseline, post intervention, and 1-month follow-up. The primary outcome measure of gait and cognition is gait speed and composite score of accuracy and reaction time of the cognitive tasks under single- and dual-task conditions. The secondary outcome measures will be the Mini-BESTest, single- and dual-TUG, Functional Gait Assessment, 6-minute Walk Test, physical activity monitor, and Stroke Impact Scale. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up among the groups.

注册库
clinicaltrials.gov
开始日期
2020年8月14日
结束日期
2023年10月31日
最后更新
2年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Li-Ling Chuang

Associated Professor

Chang Gung University

入排标准

入选标准

  • first-ever stroke with onset duration more than 3 months
  • able to walk 10 m
  • 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.

结局指标

主要结局

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 or Physilog® sensors (Gait Up, Switzerland). The primary gait parameter is gait speed (cm/s) under single-task and dual-task walking conditions using the 10 Meter Walking Test.

composite score

时间窗: 5 minutes

For the Stroop task, we will calculate the composite score for the Stroop task under single-task and dual-task walking conditions by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs.

次要结局

  • Mini-Balance Evaluation Systems Test (Mini-BESTest)(10 minutes)
  • Timed Up and Go Test (TUG)(2 minutes)
  • Functional Gait Assessment (FGA)(10 minutes)
  • 6-minute Walk Test(6 minutes)
  • Berg Balance Scale (BBS)(5-10 minutes)
  • Physical activity monitor(3 days)
  • Stroke Impact Scale Version 3.0 (SIS 3.0)(10 minutes)
  • Patient Global Impression of Change Scale (PGIC)(1 minute)

研究点 (1)

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