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Completed

NCT Number: NCT03570268

Preventing Falls and Participation Restrictions in Neurological Diseases

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Stroke Synucleinopathies Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Don Gnocchi ONLUS

Milan, 20148, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Experimental Group: Education

Other

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

Control Group: Usual care

Other

Participants allocated to the control group received stretching exercises.

Primary outcomes

  1. Change of Percentage of fallers

    Time frame: 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 outcomes

  1. Change of Participation level

    Time frame: Change from Baseline partecipation at 6 months.

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

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 26, 2018
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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