Preventing Falls and Participation Restrictions in Neurological Diseases
Educational and Exercise Intervention to Prevent Falls and Participation Restrictions in Subjects With Neurological Diseases
研究概览
详细说明
90 patients will be randomly patients will be stratified by disease type and randomized separately.
The trial will be organized in Baseline assessment (clinical characteristics; fall predictors, chosen among the variables found to predict falls in the observational study), experimental intervention (experimental group) vs. usual rehabilitation programs (control group) and assessment at end of treatment and six months after treatment.
The aim of the treatment will be the prevention of falls.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Milan、意大利、20148
- Fondazione Don Gnocchi ONLUS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Patients with stroke, Parkinson's disease and Multiple Sclerosis residing in the centers' catchment areas, requiring rehabilitation, and releasing a written informed consent.
Exclusion Criteria:
1. Cognitive impairment (Minimental State Examination score <21); 2. Major depression; 3. Severe joint/bone disorder interfering with mobility, 4. Aphasia if interfering with understanding the aims of the study and self-administered tests; 5. relapses in the previous three months (MS); 6. Stroke occurred in least four weeks before study entry.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Experimental group: Education group
Participants in the experimental intervention group (education group) received an educational program and tailored home exercises.
This intervention consist of multiple, interacting components supported by a handbook and audio-video material designed to teach people the skills, techniques, and strategies for preventing falls, and increase social participation and engagement in inactivity of daily living. .
After the educational session, two one hour sessions were spent to teach safe balance exercises that were developed in preceding studies, the patient was invited to perform at home for 2 months.
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Participants in the experimental intervention group received an educational program and tailored home exercises.
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有源比较器：Control Group: Usual care
Participants allocated to the control group received ongoing usual treatments.
In addition, two one hour lessons were spent to teach stretching exercises that the patient was invited to perform at home for 2 months.
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Participants allocated to the control group received stretching exercises.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change of Percentage of fallers
大体时间：Change from Baseline percentage of fallers at 6 months.
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Each patient was given a fall diary and was followed for six months with telephone contacts for six months.
The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on targeted rehabilitation programs received during the follow up, the use of walking aid and any incurred falls, with date, circumstances, underlying cause and related injuries.
A fall was defined as an unexpected event where the person inadvertently came to rest on the ground or other lower level subjects with >1 falls in the 6 months follow up were categorized as "faller".
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Change from Baseline percentage of fallers at 6 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of Participation level
大体时间：Change from Baseline partecipation at 6 months.
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The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on partecipation level.
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Change from Baseline partecipation at 6 months.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Experimental Group: Education的临床试验
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne主动，不招人
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Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中
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Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完全的