Back to resultsPreventing Falls and Participation Restrictions in Neurological Diseases
Primary Purpose
Multiple Sclerosis, Parkinson Disease, Stroke
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Experimental Group: Education
Control Group: Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Falls prevention, Education, Neurological disease
Eligibility Criteria
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.
Sites / Locations
- Fondazione Don Gnocchi ONLUS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group: Education group
Control Group: Usual care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
Change of Participation level
The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on partecipation level.
Full Information
NCT ID
NCT03570268
First Posted
May 25, 2018
Last Updated
June 15, 2018
Sponsor
Fondazione Don Carlo Gnocchi Onlus
1. Study Identification
Unique Protocol Identification Number
NCT03570268
Brief Title
Preventing Falls and Participation Restrictions in Neurological Diseases
Official Title
Educational and Exercise Intervention to Prevent Falls and Participation Restrictions in Subjects With Neurological Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 30, 2016 (Actual)
Study Completion Date
January 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Parkinson Disease, Stroke
Keywords
Falls prevention, Education, Neurological disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group: Education group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group: Usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental Group: Education
Intervention Description
Participants in the experimental intervention group received an educational program and tailored home exercises.
Intervention Type
Other
Intervention Name(s)
Control Group: Usual care
Intervention Description
Participants allocated to the control group received stretching exercises.
Primary Outcome Measure Information:
Title
Change of Percentage of fallers
Description
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".
Time Frame
Change from Baseline percentage of fallers at 6 months.
Secondary Outcome Measure Information:
Title
Change of Participation level
Description
The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on partecipation level.
Time Frame
Change from Baseline partecipation at 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fondazione Don Gnocchi ONLUS
City
Milan
ZIP/Postal Code
20148
Country
Italy
12. IPD Sharing Statement
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Preventing Falls and Participation Restrictions in Neurological Diseases
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