Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-28 @ 7:57 AM
Study NCT ID:
NCT03570268
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2018-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Falls and Participation Restrictions in Neurological Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-15', 'studyFirstSubmitDate': '2018-05-25', 'studyFirstSubmitQcDate': '2018-06-15', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Percentage of fallers', 'timeFrame': 'Change from Baseline percentage of fallers at 6 months.', '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".'}], 'secondaryOutcomes': [{'measure': 'Change of Participation level', 'timeFrame': 'Change from Baseline partecipation at 6 months.', 'description': 'The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on partecipation level.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Falls prevention', 'Education', 'Neurological disease'], 'conditions': ['Multiple Sclerosis', 'Parkinson Disease', 'Stroke']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '90 patients will be randomly patients will be stratified by disease type and randomized separately.\n\nThe 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.\n\nThe aim of the treatment will be the prevention of falls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with stroke, Parkinson's disease and Multiple Sclerosis residing in the centers' catchment areas, requiring rehabilitation, and releasing a written informed consent.\n\nExclusion Criteria:\n\n1\\. 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."}, 'identificationModule': {'nctId': 'NCT03570268', 'briefTitle': 'Preventing Falls and Participation Restrictions in Neurological Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Educational and Exercise Intervention to Prevent Falls and Participation Restrictions in Subjects With Neurological Diseases', 'orgStudyIdInfo': {'id': 'RF-2010-2318552'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group: Education group', '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.', 'interventionNames': ['Other: Experimental Group: Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group: Usual care', '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.', 'interventionNames': ['Other: Control Group: Usual care']}], 'interventions': [{'name': 'Experimental Group: Education', 'type': 'OTHER', 'description': 'Participants in the experimental intervention group received an educational program and tailored home exercises.', 'armGroupLabels': ['Experimental group: Education group']}, {'name': 'Control Group: Usual care', 'type': 'OTHER', 'description': 'Participants allocated to the control group received stretching exercises.', 'armGroupLabels': ['Control Group: Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20148', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione Don Gnocchi ONLUS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}