Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT07202520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': "After screening visit, patients are randomised between two Arms. Patients in Arm 1 start with experimental phase (H'Ability Home) and after a wash-out period start the control phase (paper). Patients randomised in Arm 2 start with the control phase and after the wash-out period start the experimental phase."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To evaluate the impact of the H'Ability Home device on the level of autonomy of post-stroke patients compared to the exercise booklet.", 'timeFrame': 'T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)', 'description': 'Level of autonomy by the functional independence measure (FIM) score. From 18 (no autonomy) to 126 (full autonomy).'}], 'secondaryOutcomes': [{'measure': "To evaluate the impact of the H'Ability Home device on the walking speed of post-stroke patients compared to the exercise booklet.", 'timeFrame': 'T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)', 'description': 'walking speed by the duration of the 10 meters of walking'}, {'measure': "To evaluate the impact of the H'Ability Home device on the coordination of post-stroke patients compared to the exercise booklet.", 'timeFrame': 'T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)', 'description': 'coordination by the Quick-DASH score (DASH: Disabilities of the Arm, Shoulder and Hand). scored from 11 (no incapacity) to 100 (full incapacity)'}, {'measure': "To evaluate the impact of the H'Ability Home device on the quality of life of post-stroke patients compared to the exercise booklet.", 'timeFrame': 'T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)', 'description': 'quality of life by the EuroQoL-5D score. from 1 (no problem) to 5 (extreme problems)'}, {'measure': "Evaluate the impact of the H'Ability Home device on satisfaction with rehabilitation exercises in post-stroke patients compared to the exercise booklet.", 'timeFrame': 'T2(week 6), T4 (week 13)', 'description': 'satisfaction by the visual digital scale Satisfaction score. From 0 (total insatisfaction) to 10 (total satisfaction)'}, {'measure': "To evaluate the effect of the H'Ability Home device on the cognitive abilities of post-stroke patients compared to the exercise booklet.", 'timeFrame': 'T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)', 'description': 'cognitive abilities by Mini-Mental State Examination score. From 0 (significant cognitive impairment) to 30 (optimal cognitive abilities)'}, {'measure': "Evaluate the impact of the H'Ability Home device on the fear of falling in relation to the exercise booklet.", 'timeFrame': 'T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)', 'description': 'fear of falling by the Short-Falls Efficacy Scale-International score scored from 7 (minimal fear) to 28 (maximal fear)'}, {'measure': "Describe patient compliance with both devices: H'Ability Home and exercise booklet.", 'timeFrame': 'T2(week 6), T4 (week 13)', 'description': 'compliance by number of connections or achievements'}, {'measure': "Evaluate the acceptability of the H'Ability Home device among patients and caregivers before use (a priori acceptability) and after use (a posteriori acceptability)", 'timeFrame': 'T0 (screening), T2(week 6), T4 (week 13)', 'description': 'acceptability by the score of the Unified Theory of Acceptance and the Use of Technology dimensions. caregiver: from 28 (low acceptance) to 196 (high acceptance). patients: from 31 (low acceptance) to 217 (high acceptance)'}, {'measure': "Describe the level of mental load of patients with the two devices: H'Ability Home and exercise booklet", 'timeFrame': 'T2(week 6), T4 (week 13)', 'description': 'mental load by NASA Task Load Index score. from 0 (low cognitive load) to 100 (high cognitive load)'}, {'measure': "Describe the level of motion sickness associated with the use of the H'Ability Home virtual reality device", 'timeFrame': 'T2(week 6), T4 (week 13)', 'description': 'motion sickness by Simulator Sickness Questionnaire score. From 0 (no cinetose) to 48 (severe cinetose)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': "The goal of this clinical investigation is to evaluate the benefit of the H'Ability Home device used in supervised self-rehabilitation at home on the autonomy of post-stroke patients.\n\nParticipants will perform their self-rehabilitation exercises at home using a virtual reality headset incorporating H'Ability Home software for 6 weeks during the experimental phase. This phase will be compared to a 6-week control phase at home, with self-rehabilitation exercises presented in a paper format.", 'detailedDescription': "This is a prospective, multicenter, randomized, controlled, crossover, and repeated-measures clinical study.\n\nPatients with a first stroke, currently undergoing rehabilitation in a center with a planned return home, and with low to reasonable susceptibility to motion sickness will be enrolled.\n\nAfter inclusion, patients will be randomized to one of two study arms.\n\n* Arm 1: Experimental phase / Washout / Control phase\n* Arm 2: Control phase / Washout phase / Experimental phase\n\nDuring the experimental phase, patients will perform their self-rehabilitation exercises at home using the H'Ability Home device for six weeks.\n\nDuring the control phase, patients will perform their self-rehabilitation exercises at home using a paper-based exercise guide for six weeks. The two study phases are separated by a one-week washout period during which patients will not perform any self-rehabilitation exercises."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Patient Inclusion Criteria:\n\n* Stroke diagnosis: first stroke, with no history of stroke, documented in the medical record\n* Currently in rehabilitation (in a center) (full hospitalization or day hospitalization for at least 3 days/week) for another 2 to 4 weeks.\n* Planned return home (home self-rehabilitation phase): Patients at the end of their rehabilitation stay and scheduled to return home where the self-rehabilitation phase can take place.\n* Ability to use virtual reality: Physical and cognitive ability to interact with virtual reality devices, at the discretion of therapists.\n* Adult: Patients aged 18 years or older.\n* Informed consent: Voluntary agreement to participate in the study after a full explanation of its terms and conditions.\n* Member of a social security scheme or eligible beneficiary\n* Distance between home and center included within the usual perimeter of each site.\n* Presence of a third-party family caregiver at home who has agreed to ensure the patient's safety during self-rehabilitation sessions with the H'Ability Home device (consent)\n* Availability of a Wi-Fi network and internet access at the patient's home\n* Presence of an adequate space at home to perform rehabilitation exercises\n* Person with low to reasonable sensitivity to motion sickness (MSSQ ≤ 15)\n\nPatient non inclusion Criteria:\n\n* • Visual disorders incompatible with the use of virtual reality (absence of binocular vision, blindness, conjunctivitis, etc.) at the discretion of the investigator. PS: Visual disorders corrected by wearing a vision correction device are not concerned because glasses or contact lenses can be worn when using an IVR headset.\n\n * Major cognitive impairment: Severe cognitive impairment affecting the patient's ability to understand or follow study instructions, or to operate the device independently, at the investigators' discretion.\n * History of epilepsy: History of epileptic seizures, particularly photosensitive seizures, which may be triggered or aggravated by the use of virtual reality.\n * Medical instability: presence of unstable or uncontrolled medical conditions that could interfere with active participation in rehabilitation.\n * Psychiatric illnesses: active psychiatric disorders (e.g., psychosis, unstabilized bipolar disorder) that could disrupt participation and continuity of rehabilitation, at the investigators' discretion.\n * Wearing implantable medical devices or personal medical devices that could be affected by radio waves (pacemakers, cochlear implants, etc.)\n * Participation in another clinical study: engagement in another clinical study likely to interfere with the study objectives or outcome assessments\n * Planned hospitalization during the home self-rehabilitation period\n * Pregnant, childbirth, or breastfeeding women\n * Persons deprived of their liberty by a judicial (including guardianship, curatorship, and judicial protection) or administrative decision\n * Persons receiving psychiatric care or admitted to a health or social care facility for purposes other than research\n * Persons in an emergency situation unable to express their prior consent\n\nThird-party family caregiver Inclusion Criteria:\n\n* Adult: Person aged 18 years or older\n* Informed consent: Voluntary agreement to participate in the study after a full explanation of its terms and conditions.\n* Member of a social security scheme or entitled person\n* Patient's family caregiver\n* Ability to assist the patient in using the device\n* Ability to ensure the patient's safety when using the device\n* Agreement to assist and ensure the patient's safety when using the device at home\n* Agreement to provide feedback on the device by completing self-administered questionnaires (UTAUT) - optional\n\nThird-party family caregiver non-inclusion Criteria:\n\n* Pregnant, childbirth, or breastfeeding women\n* Persons deprived of their liberty by a judicial (including guardianship, curatorship, and judicial protection) or administrative decision\n* Persons receiving psychiatric care or admitted to a health or social care facility for purposes other than research\n* Persons in an emergency situation unable to express their prior consent"}, 'identificationModule': {'nctId': 'NCT07202520', 'briefTitle': "Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients", 'organization': {'class': 'INDUSTRY', 'fullName': "H'ability"}, 'officialTitle': "Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients", 'orgStudyIdInfo': {'id': 'IVR-Home'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1 : IVR + Control', 'description': "6 weeks of using H'Ability Home at home (experimental phase) followed by a week of washout and then 6 weeks of using a paper-based exercise guide", 'interventionNames': ["Device: IVR : H'Ability Home", 'Device: Control: paper-based exercise guide']}, {'type': 'OTHER', 'label': 'Arm 2 : Control + IVR', 'description': "6 weeks of using a paper-based exercise guide followed by a week of washout and then 6 weeks of using H'Ability Home at home (experimental phase)", 'interventionNames': ["Device: IVR : H'Ability Home", 'Device: Control: paper-based exercise guide']}], 'interventions': [{'name': "IVR : H'Ability Home", 'type': 'DEVICE', 'description': "H'Ability Home is a Dtx (Digital therapeutics) designed for the neurological rehabilitation of patients who have suffered a stroke, via a wireless virtual reality headset, with a simplified control interface on a tablet or PC", 'armGroupLabels': ['Arm 1 : IVR + Control', 'Arm 2 : Control + IVR']}, {'name': 'Control: paper-based exercise guide', 'type': 'DEVICE', 'otherNames': ['Control'], 'description': 'self-rehabilitation booklet used in current practice in centers', 'armGroupLabels': ['Arm 1 : IVR + Control', 'Arm 2 : Control + IVR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62600', 'city': 'Berck', 'country': 'France', 'contacts': [{'name': 'Sandrine SIMOLIEN', 'role': 'CONTACT', 'email': 'sandrine.simolien@fondation-hopale.org', 'phone': '0033 3 21 89 20 20'}, {'name': 'Sandrine SIMOLIEN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondation Hopale - Centre de Jacques Calvé', 'geoPoint': {'lat': 50.4, 'lon': 1.6}}, {'zip': '83418', 'city': 'Hyères', 'country': 'France', 'contacts': [{'name': 'Isabelle THIRY-ESCUDIE', 'role': 'CONTACT', 'email': 'i.thiry@leonberard.com', 'phone': '0033 4 94 38 19 43'}, {'name': 'Isabelle THIRY-ESCUDIE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Léon Bérard', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'zip': '56270', 'city': 'Ploemeur', 'country': 'France', 'contacts': [{'name': 'Stéphanie LEPLAIDEUR', 'role': 'CONTACT', 'email': 'stephanie.leplaideur@vyv3.fr', 'phone': '0033 2 97 82 62 93'}, {'name': 'Stéphanie LEPLAIDEUR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de KERPAPE', 'geoPoint': {'lat': 47.73512, 'lon': -3.42952}}, {'zip': '35043', 'city': 'Rennes', 'country': 'France', 'contacts': [{'name': 'Emilie LEBLONG, MD, PhD', 'role': 'CONTACT', 'email': 'emilie.leblong@fondationsainthelier.com', 'phone': '0033 2 29 99 50 99'}, {'name': 'Emilie LEBLONG', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pôle Saint Hélier', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '29684', 'city': 'Roscoff', 'country': 'France', 'contacts': [{'name': 'Tanguy LE CORRE', 'role': 'CONTACT', 'email': 'tanguy.lecorre@ildys.org', 'phone': '0033 2 98 29 39 39'}, {'name': 'Tanguy LE CORRE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondation ILDYS - Centre de Perharidy', 'geoPoint': {'lat': 48.72381, 'lon': -3.98709}}], 'centralContacts': [{'name': 'Emilie LEBLONG, MD, PhD', 'role': 'CONTACT', 'email': 'emilie.leblong@fondationsainthelier.com', 'phone': '0033 2 99 29 50 99'}], 'overallOfficials': [{'name': 'Emilie LEBLONG, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pôle Saint Hélier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "H'ability", 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pôle Saint Hélier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}