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临床试验/NCT04228159
NCT04228159Unknown不适用

The Effectiveness of Perturbation Training With Balance Tutor, Compared to Balance and Strengthening Exercise, on Falls Rate Among Elderly at Risk of Falling

Clalit Health Services3 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年11月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
试验地点
3
主要终点
rate of falls and fallers

研究概览

简要总结

One third of adults over 65 and 50% of adults above 80 years old fall at list once a year. In some cases, falls result in fractures, hospitalization, functional limitations, depression, morbidity and mortality. Strong evidence support exercise training programs for fall prevention, while several studies examined the effect of perturbation training on risk of fall. The aim of this study is to evaluate the effectiveness of a perturbation training program with unexpected perturbation using balance tutor on falls and injuries among elderly at risk of falling, compared to balance and strengthening exercise.

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 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least one fall during the last 12 months; age 65-85; mini-mental state examination score 24 and above allowing cognitive ability to understand simple instructions ; Time Up and Go (TUG), assessing balance, walking ability and fall risk, scored 13 and above ; ability to read Hebrew or Arabic; and the ability to walk independently 10 meters.

排除标准

  • progressive neurological conditions (Parkinson, Multiple sclerosis, CVA); severe orthopedic conditions including lower limb or spine fractures and surgeries in the past 12 months prior to baseline; blindness; Arrhythmia; uncontrolled chronic disease (i.e., hypertension, diabetes, ischemic heart disease); diagnosed severe osteoporosis with a history of fracture during the past 3 years prior to baseline; active cancer during the past three years prior to baseline; lack of availability in the coming two months for completing the treatment protocol

结局指标

主要结局

rate of falls and fallers

时间窗: falls and fallers rates during 12-months following end of treatment

hip fractures and hospitalizations rates due to falls

时间窗: hip fractures and hospitalizations rates due to falls during12-months following end of treatment

次要结局

  • Mini-BESTest(end of treatment-last visit in physical therapy clinic)
  • Activities-Specific Balance Confidence Scale (ABC scale)(12 months after end of treatment)
  • Physical Activity Scale for the Elderly (PASE)(12 months after end of treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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