Educational and Exercise Intervention to Prevent Falls and Participation Restrictions in Subjects With Neurological Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change of Percentage of fallers
研究概览
简要总结
A randomized open clinical trial to assess the added value of a comprehensive rehabilitation program on fall prevention and improve participation and activities of daily living. Baseline assessment, 6-month experimental intervention (experimental group) vs. usual rehabilitation programs and assessment at end of treatment and six months after treatment will be performed.
详细描述
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stroke, Parkinson's disease and Multiple Sclerosis residing in the centers' catchment areas, requiring rehabilitation, and releasing a written informed consent.
排除标准
- •Cognitive impairment (Minimental State Examination score <21);
- •Major depression;
- •Severe joint/bone disorder interfering with mobility,
- •Aphasia if interfering with understanding the aims of the study and self-administered tests;
- •relapses in the previous three months (MS);
- •Stroke occurred in least four weeks before study entry.
研究组 & 干预措施
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.
干预措施: Experimental Group: Education (Other)
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.
干预措施: Control Group: Usual care (Other)
结局指标
主要结局
Change of Percentage of fallers
时间窗: Change from Baseline percentage of fallers at 6 months.
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".
次要结局
- Change of Participation level(Change from Baseline partecipation at 6 months.)