Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 10:54 AM
Study NCT ID:
NCT06032468
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2023-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARC Intellicare for Telerehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative 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': '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Early feasibility study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-09-04', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy outcome: Six minutes walking test (6MWT)', 'timeFrame': '8 weeks', 'description': 'number of meters walked in brisk 6 minutes walk'}, {'measure': 'Efficacy outcome: Borg scale', 'timeFrame': '8 weeks', 'description': 'score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)'}, {'measure': 'safety outcome: adverse event frequency', 'timeFrame': '8 weeks', 'description': 'number of adverse events reported'}, {'measure': 'Usability outcome: adherence to prescription', 'timeFrame': '8 weeks', 'description': 'percent of rehabilitation sessions completed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease', 'Multiple Sclerosis', 'Stroke']}, 'descriptionModule': {'briefSummary': "In the last 5 years, the available literature evidence has indicated that, in terms of clinical efficacy, telerehabilitation can give comparable results compared to face-to-face rehabilitation. Studies of post-stroke patients have revealed some benefits of telerehabilitation, such as the ability for patients to self-record pain, mood and activity. Telerehabilitation has comparable efficacy to face-to-face rehabilitation for the recovery of some abilities, such as motor function, Activities of Daily Living (ADL), and independence; it is less effective, however, for the recovery of balance control. Published reviews concerning, in particular, neurological/neurodegenerative diseases show that telerehabilitation systems are effective in maintaining and/or improving some motor aspects, such as balance and gait, and non-motor aspects, such as mood and quality of life; they also increase patient satisfaction, so in the long term they appear to be beneficial, convenient and satisfying for patients and operators.\n\nARC Intellicare is a device undergoing certification as a Class I Medical Device (DM), already clinically tested during two uncontrolled clinical feasibility studies: ARCANGEL study (post-stroke, ClinicalTrials.gov Identifier: NCT03787433) and RICOMINCIARE study (post-COVID19 and Parkinson's disease, ClinicalTrials.gov Identifier: NCT05074771)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with diagnosis of Parkinson's disease with Hoehn\\&Yahr staging 1-3\n* diagnosis of multiple sclerosis with extended disability scale score 3.5-6\n* diagnosis of ischemic stroke in the past 12 months\n\nExclusion Criteria:\n\n* history of falls\n* dementia\n* epilepsy"}, 'identificationModule': {'nctId': 'NCT06032468', 'acronym': 'ARCTRAN', 'briefTitle': 'ARC Intellicare for Telerehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'ARC Intellicare for Telerehabilitation in Neurological Patients', 'orgStudyIdInfo': {'id': '5135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation with ARC Intellicare Device', 'description': 'rehabilitation exercise for 8 weeks using wearable devices', 'interventionNames': ['Device: ARC Intellicare']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rehabilitation with exercise sheet', 'description': 'rehabilitation exercise for 8 weeks using rehabilitation exercise sheets', 'interventionNames': ['Other: Rehabilitation sheets']}], 'interventions': [{'name': 'ARC Intellicare', 'type': 'DEVICE', 'description': 'wearable devices to guide rehabilitation exercise', 'armGroupLabels': ['Rehabilitation with ARC Intellicare Device']}, {'name': 'Rehabilitation sheets', 'type': 'OTHER', 'description': 'rehabilitation exercise sheets to guide rehabilitation exercise', 'armGroupLabels': ['Rehabilitation with exercise sheet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'Rome', 'country': 'Italy', 'facility': 'policlinico Universitario A Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}