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临床试验/NCT06638476
NCT06638476已完成不适用

Step Training in Persons Post-stroke

Vicki Gray2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
Step initiation time

研究概览

简要总结

The goal of this clinical trial is to see if perturbation-induced step training improves stepping performance during a reactive and voluntary step. The main questions it aims to answer are:

Does perturbation induced step training improve step initation time and first recovery step?

Researchers will compare lateral perturbation induced step training to lateral voluntary step training to see if the first recovery steps improve.

Participants will:

Vist the lab for an initial assessment, post exercise and one month post exercise of voluntary and perturbation induced stepping performance, and clinical tests of balance, motor recovery, sensory and strength tests.

Exercise 3 times a week for 6 weeks in person

Track falls for 6 months after the exercise.

详细描述

Stroke is the leading cause of disability in the United States as the result of an increased survival rate over the last 25 years. A high frequency of falls is commonly reported in this group due to the residual sensorimotor deficits and impairments to balance. Many falls occur when weight is transferred laterally and an equal number of falls happen during voluntary movements as during unexpected disturbances such as a trip, push or pull. Typically, either will involve a protective step to recover balance. Thus, the purpose of this study is to compare the effects of reactive lateral step training to voluntary lateral step training on the performance of the protective step, functional balance and falls in persons post-stroke. Thirty participants with a stroke will be randomized to one of two interventions, reactive step training or voluntary step training. In the voluntary step training group, participants will perform voluntary steps. In the reactive step training group, participants will perform reactive steps generated by the Active Step. The training will be 3 times a week for 6 weeks. The step initiation time, will be compared in both the voluntary and reactive steps at baseline before the intervention, post-intervention and a test of retention will occur one month after the training. Functional balance will be assessed with the Community Balance & Mobility Scale and falls will be compared in the 6 months preceding the intervention to 6 months post-intervention testing. If reactive step training is effective, then the protective step characteristics, functional balance and the number of falls will be reduced compared to the voluntary step training group.

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
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hemiparesis as a result of a stroke greater than 6 months previous to the study
  • Able to walk 10 meters with or without a walking aid
  • Have the cognitive ability to give informed consent

排除标准

  • Medical condition precluding participation in regular exercise, such as acute cardiac or respiratory conditions limiting activity and other health conditions significantly impacting the ability to walk beyond the effects of the stroke, such as other neurological conditions or peripheral neuropathies.
  • Bilateral stroke or a previous stroke in the contralateral hemisphere.

结局指标

主要结局

Step initiation time

时间窗: Baseline, 6 weeks

Change in Step initiation time measured from the time of the puller or light cue onset to the first foot off the force platform.

First step length

时间窗: Baseline, 6 weeks

Global step length based on the displacement of the ankle marker normalized by the participants height.

次要结局

  • step velocity(Baseline, 6 weeks)
  • Step clearance(Baseline, 6 weeks)
  • Community Balance & Mobility Scale(Baseline, 6 weeks)
  • Activities Specific Balance Confidence(Baseline, 6 weeks)
  • Falls(6 months pre-enrollment, 6 months post exercise)

研究者

发起方
Vicki Gray
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Vicki Gray

Associate Professor

University of Maryland, Baltimore

研究点 (2)

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