Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-20 @ 4:30 PM
Study NCT ID:
NCT07254195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of an Intensive Motor Telerehabilitation Program for Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation in the Goal Attainment Scale (GAS) score.', 'timeFrame': 'Baseline, at 8, 20, 32 and 44 weeks', 'description': "The GAS is used to measure achievement of individual goals. GAS goals will be set for each participant before the start of the intervention. Achievement of each objective will be rated on a 5-point scale: -2 (patient's initial, pre-intervention level), -1 (progress towards goal, without complete attainment), 0 (expected level), +1 (goal achieved better than expected), +2 (best hoped-for result)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'motor', 'telerehabilitation', 'intensive therapy'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is a major cause of motor disability, particularly hemiplegia, and its incidence is increasing as the population ages. Despite partial spontaneous recovery in the first three months, 80% of patients retain a motor deficit after six months, requiring intensive rehabilitation to maximize recovery. However, after hospitalization, access to intensive rehabilitation is limited, due to geographical and mobility constraints, and the lack of reimbursement for private occupational therapy.\n\nTelerehabilitation, using digital technologies, can overcome these difficulties by offering interactive, accessible rehabilitation at home. Studies show that its effectiveness is comparable to that of clinical rehabilitation.\n\nOur study therefore proposes to evaluate the feasibility and effects of a home-based telerehabilitation program using the MindMotion GO device (MindMaze). This 12-week program aims to provide an additional intensive dose of rehabilitation to the standard of care, with 300 minutes of weekly active therapy, planned and monitored remotely by a therapist.', 'detailedDescription': 'Stroke is a major cause of motor disability, particularly hemiplegia, and its incidence is increasing as the population ages. Despite partial spontaneous recovery in the first three months, 80% of patients retain a motor deficit after six months, requiring intensive rehabilitation to maximize recovery. However, after hospitalization, access to intensive rehabilitation is limited, due to geographical and mobility constraints, and the lack of reimbursement for private occupational therapy.\n\nTelerehabilitation, using digital technologies, can overcome these difficulties by offering interactive, accessible rehabilitation at home. Studies show that its effectiveness is comparable to that of clinical rehabilitation.\n\nOur study therefore proposes to evaluate the feasibility and effects of a home-based telerehabilitation program using the MindMotion GO device (MindMaze). This 12-week program aims to provide an additional intensive dose of rehabilitation to the standard of care, with 300 minutes of weekly active therapy, planned and monitored remotely by a therapist. It combines synchronous (1time a week with a therapist) and asynchronous (autonomous) sessions.\n\nThis program is integrated into the post-stroke care pathway by facilitating the transition from hospital to home, without prolonging hospitalization or increasing face-to-face sessions.\n\nThe study will be a single-center randomized controlled trial, targeting patients in the sub-acute and chronic stages of stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized for a first ischemic or hemorrhagic stroke\n* Stroke occurrence more than 30 days prior\n* Presenting motor deficits affecting the upper limb, with or without involvement of the lower limb\n* Able to follow the instructions of the home program using the MindMotion GO device\n* Having at home an accessible email address, an Internet connection with password, a smartphone, a screen or TV with HDMI input (Full HD 1080p resolution), and a free space of approximately 1 m x 2.5 m in front of the screen\n* Ability to sit without assistance\n* Patient agreeing to participate in the study by signing an informed consent form\n* Affiliated with, or entitled to, a social security scheme\n\nExclusion Criteria:\n\nHistory of stroke\n\n* Neurological pathology other than stroke\n* Patient with uncontrolled epilepsy or seizure disorder\n* Cardiac disease limiting exercise\n* Pain limiting rehabilitation dose\n* Major comprehension problems or severe psychiatric and/or cognitive disorders that could compromise understanding of the protocol and the smooth running of the study.\n* Uncorrected hearing or visual deficits\n* Severe apraxia\n* Severe memory impairment\n* Severe unilateral spatial neglect\n* Total plegia of affected limb\n* Pregnant, parturient or breast-feeding women\n* Persons deprived of their liberty by judicial or administrative decision\n* Persons admitted to a health or social institution for purposes other than research\n* Adults under legal protection (guardianship, curatorship)\n* Subjects participating in other intervention research.'}, 'identificationModule': {'nctId': 'NCT07254195', 'acronym': 'REACT-AVC', 'briefTitle': 'Assessment of an Intensive Motor Telerehabilitation Program for Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Intensive Motor Rehabilitation of Stroke Patients: Evaluation of a Telerehabilitation Program', 'orgStudyIdInfo': {'id': '69HCL24_0504'}, 'secondaryIdInfos': [{'id': '2025-A01054-45', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TR1', 'description': 'Immediately following discharge from the rehabilitation unit, patients will participate in a 12-weeks telerehabilitation program using the MindMotion GO device, in parallel to the standard care.\n\nDuring the 12-weeks program, patients will aim to achieve at least 300 minutes of active therapy time per week using the MindMotion GO device at their home. They will have 1 synchronous rehabilitation session per week in clinic or remotely via videoconference with a PT or an OT. The rest of the sessions will be done asynchronously and independently by the patient. The activity schedule will be drawn up by a therapist remotely and will be personalized for each patient.\n\nAfter 12 weeks, the patients will be asked whether they wish to continue with the telerehabilitation program. Patients who agree to continue will pursue the program for another 12 weeks, in parallel to standard care.\n\nPatients who do not want to continue the program will only receive standard care for the following 12 weeks.', 'interventionNames': ['Device: Telerehabilitation program using the MindMotion GO device']}, {'type': 'OTHER', 'label': 'TR2', 'description': 'Following discharge from the rehabilitation unit, patients will receive only standard care for 12 weeks.\n\nThen, they will start the telerehabilitation program using the MindMotion GO device for 12 weeks, in parallel to the standard care. During the 12-weeks program, patients will aim to achieve at least 300 minutes of active therapy time per week using the MindMotion GO device at their home. They will have 1 synchronous rehabilitation session per week in clinic or remotely via videoconference with a PT or an OT. The rest of the sessions will be done asynchronously and independently by the patient. The activity schedule will be drawn up by a therapist remotely and will be personalized for each patient.', 'interventionNames': ['Device: Telerehabilitation program using the MindMotion GO device']}], 'interventions': [{'name': 'Telerehabilitation program using the MindMotion GO device', 'type': 'DEVICE', 'description': 'In parallel to the standard of care, patients will participate in a 12-weeks telerehabilitation program using the MindMotion GO device.\n\nMindMotion GO is a digital therapy device that offers a catalog of interactive games designed specifically for patients with neurological injuries.\n\nDuring the telerehabilitation program, patients will aim to achieve at least 300 minutes of active therapy per week. They will have 1 synchronous session per week in the clinic or remotely by videoconference with a therapist (PT or OT). Patients are expected to carry out the other planned sessions independently at home. The activity schedule will be drawn up by a remote therapist each week and will be personalized for each patient.', 'armGroupLabels': ['TR1', 'TR2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69230', 'city': 'Saint-Genis-Laval', 'state': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Jacques LUAUTÉ, MD, PhD', 'role': 'CONTACT', 'email': 'Jacques.luaute@chu-lyon.fr', 'phone': '4 78 86 50 64', 'phoneExt': '+33'}], 'facility': 'Hopital Henry Gabrielle', 'geoPoint': {'lat': 45.69542, 'lon': 4.79316}}], 'centralContacts': [{'name': 'Jacques LUAUTÉ, MD', 'role': 'CONTACT', 'email': 'Jacques.luaute@chu-lyon.fr', 'phone': '4 78 86 50 64', 'phoneExt': '+33'}, {'name': 'Anne-Laure CHARLOIS', 'role': 'CONTACT', 'email': 'anne-laure.charlois@chu-lyon.fr', 'phone': '478 86 51 13', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}