Multiple Sclerosis, Parkinson Disease, Stroke
Conditions
Keywords
Falls prevention, Education, Neurological disease
Brief summary
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
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.
Interventions
OTHERExperimental Group: Education
Participants in the experimental intervention group received an educational program and tailored home exercises.
Participants allocated to the control group received stretching exercises.
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Percentage of fallers | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Participation level | Change from Baseline partecipation at 6 months. | The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on partecipation level. |
Countries
Italy
Outcome results
None listed