Preventing Falls and Participation Restrictions in Neurological Diseases

Fondazione Don Carlo Gnocchi Onlus90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis Parkinson Disease Stroke

Interventions

Experimental Group: EducationOTHER

Participants in the experimental intervention group received an educational program and tailored home exercises.

Control Group: Usual careOTHER

Participants allocated to the control group received stretching exercises.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione Don Gnocchi ONLUS

Milan, Italy

Outcomes

Primary Outcomes

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".

Time frame: Change from Baseline percentage of fallers at 6 months.

Secondary Outcomes

Change of Participation level

The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on partecipation level.

Time frame: Change from Baseline partecipation at 6 months.

Data from ClinicalTrials.gov

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