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临床试验/NCT01439451
NCT01439451已完成不适用

Effect of Balance Perturbation to Improve Gait and Balance Control and Prevent Falls in Elderly Persons -A Randomized Control Trial

Barzilai Medical Center3 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
3
主要终点
voluntary and compensatory step execution times in miliseconds

研究概览

简要总结

The proposed project is a prospective experimental Randomized Control Trial study design. Independent old adults (age 70 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after Peturbation balance training during walking to explore whether there are differences in balance control and balance reactions as a result of training.

详细描述

A total of 48 old adults will be enrolled, evaluated and trained. They will be randomly assigned to two groups: one exercise group (perturbation training) and one group without perturbation. No gender based differences are expected for the recovery outcome measures so we will be able to pool male and female individuals for this analysis. Each subject of the experimental and of the control groups will be trained on 24 occasions over a period of 10-12 weeks (20-30 minutes, 2-3 times/week). This regimen was based on previous balance training study that demonstrated improvements in balance control with similar training duration and frequency. Gait and balance function and physical activity level will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit and carryover of training. In addition using monthly phone calls, falls, their severity, functional activity limitations in the home and community setting and health status will be monitored 12 months after the training period.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Be 70 years or older, male or female
  • Be an independent ambulator (not cane or walker) and provide medical waiver from MD.

排除标准

  • Severe focal muscle weakness or paralysis, after Total Hip or knee arthroplasty
  • Moderate-severe dementia (Mini-Mental Score < 24).
  • Serious visual impairment
  • Severe peripheral or compression/entrapment neuropathies.
  • Symptomatic orthostatic hypotension, respiratory, cardiovascular, musculoskeletal, or neurological disorders that may interfere with participation in the exercise program.
  • Cancer, metastatic or under active treatment.

结局指标

主要结局

voluntary and compensatory step execution times in miliseconds

时间窗: change from baseline to 3 months later

the time from perturbation to foot contact the floor completing the recovary stepping will be measured in miliseconds

次要结局

  • postural sway parameters such as mediolateral sway in milimeters and elliptical area in milimeters squeres(Time 1: pre test' and 3 months later time 2: post testing procedure)

研究者

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

Ornit Cohen

IRB Coordinator

Barzilai Medical Center

研究点 (3)

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