Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-31 @ 7:26 AM
Study NCT ID:
NCT03201692
Status:
UNKNOWN
Last Update Posted:
2017-07-27
First Post:
2017-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Dynamic Balance and Gait Adaptability Using Treadmill Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-06-26', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Modified Dynamic Gait Index', 'timeFrame': 'Change from Baseline Modified Dynamic Gait Index scores at 3-5 weeks', 'description': 'Tool used to assess dynamic balance'}, {'measure': 'Change in the 6 minutes walking test', 'timeFrame': 'Change from Baseline 6 minutes walking test scores at 3-5 weeks', 'description': 'tool used to assess walking endurance'}], 'secondaryOutcomes': [{'measure': 'Change in Activity Balance Confidence', 'timeFrame': 'Change from Baseline Activity Balance Confidence scores at 3-5 weeks', 'description': 'Tool used to assess of balance confidence in daily life activities'}, {'measure': 'Change in 10-meter walking test', 'timeFrame': 'Change from Baseline10-meter walking test scores at 3-5 weeks', 'description': 'Tool used to assess walking speed in 3 different conditions ( normal speed, fastest speed, cognitive dual task)'}, {'measure': 'Change in Trial Making test', 'timeFrame': 'Change from Baseline Trial Making test scores at 3-5 weeks', 'description': 'The Trail Making Test is a neuropsychological tapping visual attention and task switching. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.'}, {'measure': "Change in Raven's Matrices", 'timeFrame': "Change from Baseline Raven's Matrices scores at 3-5 weeks", 'description': 'Test used in measuring abstract reasoning and regarded as a non-verbal estimate of fluid intelligence.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Stroke', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'Balance and gait problems in subjects with neurological disease lead to reduced mobility, loss of independence and frequent falls. Treadmill training is a widely used form of treatment and it has been used in subjects with neurological disease to ameliorate walking and balance deficits. The Virtual Reality Treadmill as a therapeutic tool has been recently introduced to practice gait adaptability elicited by aligning foot placement relative to the projected visual context.\n\nForty-eight subjects with neurological disease will receive treadmill training treatment randomly divided in Traditional Treadmill training and Virtual Reality Treadmill training.\n\nThe aim of this randomized controlled study is to assess whether Treadmill training with Virtual Reality is better than Traditional Treadmill training in improving dynamic balance and cognitive aspects in subjects with neurological diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Multiple Sclerosis (no relapse within the previous three months;), Parkinsons Disease (Hoenhn and Yahr Scale ≤4), Stroke (Time from onset \\>2 months)\n* Able to walk 20 meters with or without assistive device\n* Cognitive impairment (MMSE score ≥ 21)\n\nExclusion Criteria:\n\n* Unable to understand the aim of the study and unable to sign the informed consent\n* Steroidal drugs therapy for subjects with Multiple Sclerosis\n* Subjects with Psychiatric disorders\n* Subjects with Visual impairments\n* Subjects with cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT03201692', 'briefTitle': 'Improving Dynamic Balance and Gait Adaptability Using Treadmill Training', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Improving Dynamic Balance and Gait Adaptability Using Treadmill Training With Visual Cues in Subjects With Neurological Disorders: Design of a Pilot Study', 'orgStudyIdInfo': {'id': 'NCT02960984UL_SM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treadmill Training', 'description': "40' treadmill training walking holding the handrail", 'interventionNames': ['Device: Treadmill training']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Treadmill Training', 'description': "40' treadmill training walking with virtual visual and auditory cues", 'interventionNames': ['Device: Virtual Reality Treadmill Training']}], 'interventions': [{'name': 'Virtual Reality Treadmill Training', 'type': 'DEVICE', 'otherNames': ['C-mill treadmill'], 'description': 'Subjects in the experimental group will receive 40 minutes comprising exercises focused on improving dynamic balance following auditory and visual cues.', 'armGroupLabels': ['Virtual Reality Treadmill Training']}, {'name': 'Treadmill training', 'type': 'DEVICE', 'description': 'Subjects in the active comparator group will receive 40 minutes walking training aimed to improve velocity and endurance.', 'armGroupLabels': ['Treadmill Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20148', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'ELISA GERVASONI, MSc', 'role': 'CONTACT'}], 'facility': 'Don Gnocchi Foundation', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Paolo MOcarelli, MD', 'role': 'CONTACT', 'email': 'pmocarelli@dongnocchi.it', 'phone': '+390210308', 'phoneExt': '405'}, {'name': 'Davide Cattaneo, PhD', 'role': 'CONTACT', 'email': 'dcattaneo@dongnocchi.it', 'phone': '+390240308', 'phoneExt': '814'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator, LaRiCE Lab, PhD', 'investigatorFullName': 'Davide Cattaneo', 'investigatorAffiliation': 'Fondazione Don Carlo Gnocchi Onlus'}}}}