Preventing Falls and Participation Restrictions in Neurological Diseases

NCT03570268 | Completed DMC

• 1 other identifier: RF-2010-2318552
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Parkinson Disease; Stroke

Keywords

Falls prevention; Education; Neurological disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of Participation level

  Change from Baseline partecipation at 6 months.

Study Arms (2)

Experimental group: Education group

EXPERIMENTAL

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.

Other: Experimental Group: Education

Control Group: Usual care

ACTIVE COMPARATOR

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.

Other: Control Group: Usual care

Interventions

Experimental Group: Education OTHER

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

Experimental group: Education group

Control Group: Usual care OTHER

Participants allocated to the control group received stretching exercises.

Control Group: Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stroke, Parkinson's disease and Multiple Sclerosis residing in the centers' catchment areas, requiring rehabilitation, and releasing a written informed consent.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Gnocchi ONLUS

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis; Parkinson Disease; Stroke; Nervous System Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 26, 2018
• Study Start: January 1, 2015
• Primary Completion: December 30, 2016
• Study Completion: January 15, 2017
• Last Updated: June 26, 2018

Record last verified: 2018-04

Locations

IT (1)