Preventing Falls and Participation Restrictions in Neurological Diseases

NCT ID: NCT03570268

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-01-15

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.

Conditions

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Multiple Sclerosis Parkinson Disease Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental group: Education group

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.

Group Type EXPERIMENTAL

Experimental Group: Education

Intervention Type OTHER

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 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.

Group Type ACTIVE_COMPARATOR

Control Group: Usual care

Intervention Type OTHER

Participants allocated to the control group received stretching exercises.

Interventions

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Experimental Group: Education

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

Intervention Type OTHER

Control Group: Usual care

Participants allocated to the control group received stretching exercises.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Don Gnocchi ONLUS

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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RF-2010-2318552

Identifier Type: -

Identifier Source: org_study_id

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