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临床试验/NCT02862379
NCT02862379终止不适用

Evaluation of a Personalized Rehabilitation Program for Elderly Patients That Fall : Impact on the Fear of Falling

Lille Catholic University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
68
试验地点
2
主要终点
Falls Efficacy Scale (FES-I)

研究概览

简要总结

The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death.

The goal of this study is to evaluate a personalized rehabilitation program for elderly patients that fall for the first time and to measure the impact on the fear of falling of these patients. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Persons who have fallen minimum twice the last year
  • 60 years old or more
  • Mini Mental State Examination (MMSE) equal or superior to 23/30
  • Persons who gave consent to participate in the study
  • Persons with severe visual or hearing impairment

排除标准

  • Patients with severe disease that might interfere with walking or with program monitoring

研究组 & 干预措施

Elderly patients that fall

Experimental

Personalized rehabilitation program for elderly patients that fall for the first time. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.

干预措施: home-based program (Behavioral)

结局指标

主要结局

Falls Efficacy Scale (FES-I)

时间窗: Change from baseline at 6 months and 12 months

The FES is a 10-item validated questionnaire that can be self-administered or completed during an interview. The person is asked to indicate on a 10-level rating scale his/her level of confidence in his/her capacity to accomplish a variety of activities of daily life (e.g., going up and down the stairs, taking a bath or shower) without falling. A FES score is calculated by adding up the score of each item.

次要结局

  • Life Space Assessment scale(Change from baseline at 6 months and 12 months)
  • Measure of the time that the patient is able to stay in station bipedal standing feet together followed by a monopodal support(Change from baseline at 6 months and 12 months)
  • Incidence of falls during one year(through the study completion, an average of 12 months)
  • Tinetti test(Change from baseline at 6 months and 12 months)
  • Number of falls the previous year before inclusion(at baseline)
  • Get up and go test(Change from baseline at 6 months and 12 months)
  • Walking and talking test(Change from baseline at 6 months and 12 months)
  • EuroQol five dimensions questionnaire (EQ-5D)(Change from baseline at 6 months and 12 months)

研究者

发起方
Lille Catholic University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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