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临床试验/NCT01537341
NCT01537341撤回不适用

Asymmetric Locomotor Training in the Elderly to Restore Physical Function

University of Florida0 个研究点开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Change in gait speed, as measure by 400 meter walk time, following 12-weeks of intervention

研究概览

简要总结

Innovative advances in rehabilitation technology have created a split-belt treadmill capable of providing a much needed intervention aimed at limiting mobility disability. When desynchronized, the split-belt treadmill imposes demands on each leg such that the central nervous system must adapt to the challenge. Based on preliminary data from our lab utilizing the split-belt treadmill, the investigators hypothesize this intervention can challenge the locomotor processes required for safe, efficient gait while concurrently providing an aerobic stimulus will produce favorable changes in physical function in older adults at risk for mobility disability.

详细描述

For this pilot study the investigators will enroll 20 sedentary older adults at risk for disability (usual gait speed ≤ 1.0 m/s). Participants will be assigned to one of two 12-week interventions. Therefore the final training pool will consist of 10 split-belt participants and 10 traditional treadmill participants. Aim 1 will test the hypothesis that compared with a traditional treadmill intervention a split-belt treadmill intervention will result in improved mobility, as measure by 400 meter walk time, as well self reported physical function/disability as measured by the Pepper Assessment Tool for Disability. Aim 2 will test the hypothesis that compared with a traditional treadmill intervention a split-belt treadmill intervention will results in improved gait variability. To date, no experimental study has evaluated these propositions in a controlled trial testing the effects of split-belt training in older adults at risk for disability.

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
65 Years 至 89 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 65 to 89
  • walking speed of ≤ 1 m/s
  • ≥ 0.033s of stance time variability
  • sedentary as defined by spending less than 20 minutes per week in the past month getting regular physical activity

排除标准

  • Significant cognitive impairment
  • Failure to provide informed consent
  • The need of a walker during the 400 meter walk
  • Progressive, degenerative neurological disease
  • Severe diabetes, requiring use of insulin

结局指标

主要结局

Change in gait speed, as measure by 400 meter walk time, following 12-weeks of intervention

时间窗: Participants will be evaluated within 1-week prior to begining the intervention and within 1-week following completion of the 12-week intervention

Participants will be asked to walk at their usual pace, without over exerting. They can stop for up to 1 min for fatigue or other symptoms. A time limit of 15 minutes to perform the test has been established based on the following considerations.

次要结局

  • Change in gait variability from pre to post 12-week intervention(Participants will be evaluated within 1-week prior to begining the intervention and within 1-week following completion of the 12-week intervention)

研究者

申办方类型
Other
责任方
Sponsor

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