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RECRUITING Not applicable ClinicalTrials.gov

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: H'ability • ClinicalTrials.gov ID: NCT07202520

Registry updated: 2026-09-22
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Description

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. Participants 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.

Interventions

  • IVR : H'Ability Home (Device)
    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
  • Control: paper-based exercise guide (Device)
    self-rehabilitation booklet used in current practice in centers

Eligibility criteria

Patient Inclusion Criteria: * Stroke diagnosis: first stroke, with no history of stroke, documented in the medical record * Currently in rehabilitation (in a center) (full hospitalization or day hospitalization for at least 3 days/week) for another 2 to 4 weeks. * 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. * Ability to use virtual reality: Physical and cognitive ability to interact with virtual reality devices, at the discretion of therapists. * Adult: Patients aged 18 years or older. * Informed consent: Voluntary agreement to participate in the study after a full explanation of its terms and conditions. * Member of a social security scheme or eligible beneficiary * Distance between home and center included within the usual perimeter of each site. * 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) * Availability of a Wi-Fi network and internet access at the patient's home * Presence of an adequate space at home to perform rehabilitation exercises * Person with low to reasonable sensitivity to motion sickness (MSSQ ≤ 15) Patient non inclusion Criteria: * • 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. * 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. * History of epilepsy: History of epileptic seizures, particularly photosensitive seizures, which may be triggered or aggravated by the use of virtual reality. * Medical instability: presence of unstable or uncontrolled medical conditions that could interfere with active participation in rehabilitation. * Psychiatric illnesses: active psychiatric disorders (e.g., psychosis, unstabilized bipolar disorder) that could disrupt participation and continuity of rehabilitation, at the investigators' discretion. * Wearing implantable medical devices or personal medical devices that could be affected by radio waves (pacemakers, cochlear implants, etc.) * Participation in another clinical study: engagement in another clinical study likely to interfere with the study objectives or outcome assessments * Planned hospitalization during the home self-rehabilitation period * Pregnant, childbirth, or breastfeeding women * Persons deprived of their liberty by a judicial (including guardianship, curatorship, and judicial protection) or administrative decision * Persons receiving psychiatric care or admitted to a health or social care facility for purposes other than research * Persons in an emergency situation unable to express their prior consent Third-party family caregiver Inclusion Criteria: * Adult: Person aged 18 years or older * Informed consent: Voluntary agreement to participate in the study after a full explanation of its terms and conditions. * Member of a social security scheme or entitled person * Patient's family caregiver * Ability to assist the patient in using the device * Ability to ensure the patient's safety when using the device * Agreement to assist and ensure the patient's safety when using the device at home * Agreement to provide feedback on the device by completing self-administered questionnaires (UTAUT) - optional Third-party family caregiver non-inclusion Criteria: * Pregnant, childbirth, or breastfeeding women * Persons deprived of their liberty by a judicial (including guardianship, curatorship, and judicial protection) or administrative decision * Persons receiving psychiatric care or admitted to a health or social care facility for purposes other than research * Persons in an emergency situation unable to express their prior consent

Conditions

Stroke

Locations

  • Fondation Hopale - Centre de Jacques Calvé — Berck, France
  • Hôpital Léon Bérard — Hyères, France
  • Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de KERPAPE — Ploemeur, France
  • Pôle Saint Hélier — Rennes, France
  • Fondation ILDYS - Centre de Perharidy — Roscoff, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record