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临床试验/NCT05352009
NCT05352009已完成不适用

The Application of Sling Exercise Training in People With Chronic Stroke - The Emphasis of Core Muscle Control on Gait

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Gait performance: change in single leg support time

研究概览

简要总结

The purpose of this single-blinded, randomized controlled study aims to investigate the effects of sling exercise training (SET) for core muscle on gait performance in people with chronic stroke.

详细描述

Background and purpose: Balance and gait performance are often impaired in people post stroke. Evidence showed positive correlations between trunk control and balance and walking ability. Previous studies applying core muscle training reported positive effects on improving trunk control and sitting balance among patients with chronic stroke, but benefits on standing balance and gait performance remain undetermined. Sling exercise training (SET) has been suggested for improving core muscle stability and strength in people with stroke. However, studies about effects of SET on gait performance in stroke populations are limited. Therefore, the present study aims to investigate the effects of SET for core muscle on gait performance in people with chronic stroke.

Methods: Thirty-eight individuals with chronic stroke will be recruited and assigned to one of the two groups by randomization, sling exercise training group and conventional training group. The training is 30 minutes per session, 3 sessions per week for total of 4 weeks. Gait performance is the primary outcome to include gait speed, stride length, single leg support time and temporal and spatial symmetry measured by GAITRite® System. Secondary outcomes include balance, timed up-and-go (TUG) test and trunk performance. All outcomes will be assessed before, after the 4-week training program and at 4-week follow-up.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke after onset ≥ 6 months
  • Trunk impairment scale (TIS) score ≤ 21 at baseline
  • Brunnstrome stage ≥ IV over the affected lower extremity
  • Ability to independently walk for 10 meters with or without assistive devices
  • Intact cognition with mini-mental state examination (MMSE) ≥ 24

排除标准

  • Any other significant musculoskeletal disorder, neurological disease or cardiovascular disease that may affect the participation in this study.
  • Vision or language deficit that may affect participating in this study.

结局指标

主要结局

Gait performance: change in single leg support time

时间窗: Change from baseline single leg support time at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

Using GAITRite® system to evaluate single leg support time in comfortable speed

Gait performance: change in gait speed

时间窗: Change from baseline gait speed at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

Using GAITRite® system to evaluate gait speed in comfortable speed

Gait performance: change in stride length

时间窗: Change from baseline stride length at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

Using GAITRite® system to evaluate stride length in comfortable speed

Gait performance: change in temporal and spatial symmetry index

时间窗: Change from baseline temporal and spatial symmetry index at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

Using GAITRite® system to evaluate temporal and spatial symmetry index in comfortable speed

次要结局

  • Change in trunk muscle strength: trunk flexors(Change from baseline strength of trunk flexors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Change in trunk muscle strength: trunk extensors(Change from baseline strength of trunk extensors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Balance: change in directional control(Change from baseline directional control at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Balance: change in one leg stance(Change from baseline postural sway under one leg stance at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Balance: change in functional balance performance(Change from baseline BBS at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Balance: change in maximal excursion(Change from baseline maximal excursion at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Change in mobility performance(Change from baseline mobility performance at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Change in trunk control(Change from baseline TIS at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Change in trunk muscle strength: trunk lateral flexors(Change from baseline strength of trunk lateral flexors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Balance: change in movement velocity(Change from baseline movement velocity at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))

研究者

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

Ray-Yau Wang

Professor

National Yang Ming Chiao Tung University

研究点 (2)

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