Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 4:45 PM
Study NCT ID:
NCT04874051
Status:
UNKNOWN
Last Update Posted:
2023-03-22
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The experimental group is treated through a sensor-based devices in a virtual environment, while the control group is treated through conventional physiotherapy for balance rehabilitation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Instrumental assessment', 'timeFrame': 'Change from baseline BBS at the end of the therapy (three weeks thereafter)', 'description': 'The OAK system will record the changes of the center of pressure during 30 seconds, with relaxed arms and eyes open.'}], 'primaryOutcomes': [{'measure': 'Berg Balance Scale (BBS)', 'timeFrame': 'Change from baseline Berg Balance Scale at the end of the therapy (three weeks thereafter)', 'description': 'Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 56).'}], 'secondaryOutcomes': [{'measure': 'Number of falls during the last year', 'timeFrame': 'Change from baseline number of falls during the last year scale at the end of the therapy (three weeks thereafter)', 'description': 'Applied at the beginning and at the end of treatment (after 15 sessions).'}, {'measure': 'Functional Ambulation Classification (FAC)', 'timeFrame': 'Change from baseline Functional Ambulation Classification at the end of the therapy (three weeks thereafter)', 'description': 'Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 5).'}, {'measure': 'Activities specific-Balance Confidence scale (ABC)', 'timeFrame': 'Change from baseline Activities specific-Balance Confidence scale at the end of the therapy (three weeks thereafter)', 'description': 'Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 100).'}, {'measure': 'Functional Independence Measure (FIM)', 'timeFrame': 'Change from baseline Functional Independence Measure at the end of the therapy (three weeks thereafter)', 'description': 'Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 126).'}, {'measure': 'Barthel Index (BI)', 'timeFrame': 'Change from baseline Barthel Index at the end of the therapy (three weeks thereafter)', 'description': 'Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 100).'}, {'measure': 'National Institution of Health Stroke Scale (NIHSS)', 'timeFrame': 'Change from baseline National Institute of Health Stroke Scale at the end of the therapy (three weeks thereafter)', 'description': 'Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 42).'}, {'measure': "Unified Parkinson's Disease Rating Scale (UPDRS)", 'timeFrame': "Change from baseline Unified Parkinson's Disease Rating Scale at the end of the therapy (three weeks thereafter)", 'description': 'Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 147).'}, {'measure': 'Hoehn & Yahr Scale (H&Y)', 'timeFrame': 'Change from baseline Hoehn & Yahr Scale at the end of the therapy (three weeks thereafter)', 'description': 'Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 5).'}, {'measure': 'Kurtzke Extended Disability Status Scale (EDSS)', 'timeFrame': 'Change from baseline Kurtzke Extended Disability Status Scale at the end of the therapy (three weeks thereafter)', 'description': 'Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 10).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balance', 'Sensor-based rehabilitation', 'Virtual Reality'], 'conditions': ['Stroke', 'Multiple Sclerosis', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'Balance impairment is one of the most common disorders due to a neurological diseases. Sensor-based technologies may be useful for falls prevention and balance recovery during patients hospitalization. OAK Elderly Care System (Khymeia Group, Noventa Padovana, Italy) allows the assessment of fall risk, the centre of pressure and the execution of balance exercises in a virtual environment.', 'detailedDescription': 'The aim of the study is to compare the therapy provided by means of the OAK Elderly Care System with conventional physiotherapy for balance rehabilitation in patients affected by stroke, Multiple Sclerosis (MS) and Parkinson Disease (PD).\n\nOAK Elderly Care System consists of two independent balance boards and three sensors for the kinematic tracking of the trunk and lower limbs. These components allow the assessment of the centre of pressure and the execution of exercises in a virtual environment.\n\n120 patients (40 stroke, 40 MS, 40 PK) hospitalized at 4 different italian hospitals, were enrolled according to inclusion and exclusion criteria and randomly assigned to two groups (i.e. intervention group, control group). Intervention group received 1 daily hour of technology-based treatment, while the control group underwent 1 daily hour of physiotherapy for balance rehabilitation, in addiction to 1 hour of conventional physiotherapy. Both treatments lasted 15 sessions. Before and after treatment balance, walking, daily living autonomy and pathology-specific features were assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCommon criteria:\n\n* Berg Balance Scale \\< 50/56;\n* Ability to maintain the standing position with o without one support for 1 minute;\n* Functional Independence measure \\< 100/126;\n* Barthel Index \\< 80/100.\n\nStroke:\n\n* Single ischemic stroke;\n* Lesion occured after 2 and within 18 months;\n* National Institute of Health Stroke Scale ≤ 14.\n\nParkinson:\n\n* 1.5 \\< Hoehn \\& Yahr \\< 3;\n* Subitem "freezing when walking"of the UPDRS ≤ 2.\n\nMultiple Sclerosis:\n\n* Relapsing remitting or secondary progressive Multiple Sclerosis;\n* Expanded Disability Status Scale ≤ 6.5.\n\nExclusion Criteria:\n\n* Untreated epilepsy;\n* Major depressive disorder;\n* Fractures;\n* Dementia;\n* Ideomotor Apraxia;\n* Neglect;\n* Severe impairment of verbal comprehension;\n* Severe acoustic and visual disorders.'}, 'identificationModule': {'nctId': 'NCT04874051', 'acronym': 'BALANCE', 'briefTitle': 'Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Camillo, Venezia, Italy'}, 'officialTitle': 'Sensor-Based Analysis And rehabiLitation of bAlance in Neurological Diseases: a multiCentric randomizEd Clinical Trial', 'orgStudyIdInfo': {'id': '1099/IRCCS San Camillo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group (EG)', 'description': 'In the EG the subjects will perform balance exercises using the OAK system under the supervision of a trained physiotherapist. The treatment will last 3 weeks with daily sessions of 60 minutes, 5 times per week.', 'interventionNames': ['Device: Experimental Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (CG)', 'description': 'In the CG the subjects will be asked to perform conventional balance exercises under the supervision of a physiotherapist. The treatment will last 3 weeks with daily sessions of 60 minutes, 5 times per week.', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Experimental Group', 'type': 'DEVICE', 'description': 'The experimental treatment will be provided by means of the OAK system. This device consists of 1 cabinet with 2 independent balance boards, 2 monitors (one for the physiotherapist and one for the patient) and 3 wireless IMUs (one for the left lower limb, one for the right lower limb and one for the trunk). The 2 balance boards provide body weight transfer exercises, while the wireless motion sensors provide one leg stance exercises or trunk exercises in a virtual environment.', 'armGroupLabels': ['Experimental Group (EG)']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'The Control Group will perform conventional balance exercises similar to the exercises provided with the OAK system.', 'armGroupLabels': ['Control Group (CG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristina Tassorelli, Prof.', 'role': 'CONTACT', 'email': 'cristina.tassorelli@unipv.it', 'phone': '0382380425'}, {'name': 'Roberto De Icco', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IRCCS Fondazione Mondino', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giorgio Maggioni, Dr.', 'role': 'CONTACT', 'email': 'giorgio.maggioni@icsmaugeri.it', 'phone': '0322884711'}], 'facility': 'IRCCS ICS Maugeri Spa SB', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '00163', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Franceschini, Dr.', 'role': 'CONTACT', 'email': 'marco.franceschini@sanraffaele.it'}, {'role': 'CONTACT', 'phone': '06660581'}, {'name': 'Michela Goffredo', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IRCCS San Raffaele Pisana', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00179', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Morone, Dr.', 'role': 'CONTACT', 'email': 'g.morone@hsantalucia.it'}], 'facility': 'IRCCS Fondazione Santa Lucia', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '30126', 'city': 'Venice', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Baldan', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sara Federico', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Martina Pavanetto', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'San Camillo IRCCS', 'geoPoint': {'lat': 45.43713, 'lon': 12.33265}}], 'centralContacts': [{'name': 'Andrea Turolla, PhD', 'role': 'CONTACT', 'email': 'andrea.turolla@ospedalesancamillo.net', 'phone': '00390412207', 'phoneExt': '531'}], 'overallOfficials': [{'name': 'Andrea Turolla, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Camillo IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Camillo, Venezia, Italy', 'class': 'OTHER'}, 'collaborators': [{'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, {'name': 'Istituti Clinici Scientifici Maugeri SpA', 'class': 'OTHER'}, {'name': 'IRCCS National Neurological Institute "C. Mondino" Foundation', 'class': 'OTHER'}, {'name': 'I.R.C.C.S. Fondazione Santa Lucia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}