Preventing Falls and Participation Restrictions in Neurological Diseases

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Parkinson Disease; Stroke

• Registration Number: NCT03570268
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2016-12-30
• Study Completion: 2017-01-15
• Status Verified: 2018-04
• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-06-15
• Last Update Submitted: 2018-06-15
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fondazione Don Gnocchi ONLUS; 🇮🇹 Milan, Italy