Preventing Falls and Participation Restrictions in Neurological Diseases

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570268
• Other study ID #: RF-2010-2318552
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: January 15, 2017

Study information

• Verified date: April 2018
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 15, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Nervous System Diseases
• Parkinson Disease
• Stroke

Intervention

Other:
• Experimental Group: Education
Participants in the experimental intervention group received an educational program and tailored home exercises.
• Control Group: Usual care
Participants allocated to the control group received stretching exercises.

Locations

Country	Name	City	State
Italy	Fondazione Don Gnocchi ONLUS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.