Preventing Falls and Participation Restrictions in Neurological Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Educational and Exercise Intervention to Prevent Falls and Participation Restrictions in Subjects With Neurological Diseases

Conditions
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Multiple Sclerosis, Parkinson Disease, Stroke

Intervention / Treatment
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* Other: Experimental Group: Education
* Other: Control Group: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group: Education group<br>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. | Other: Experimental Group: Education<br>* Participants in the experimental intervention group received an educational program and tailored home exercises.<br>|
| Active Comparator: Control Group: Usual care<br>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. | Other: Control Group: Usual care<br>* Participants allocated to the control group received stretching exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Percentage of fallers | 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. | Change from Baseline percentage of fallers at 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Participation level | The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on partecipation level. | Change from Baseline partecipation at 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls prevention, Education, Neurological disease