RecruitingNot ApplicableNCT07202520

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

Enrollment

44 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria36

  • 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)
  • 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
  • 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
  • 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

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Interventions

DEVICEIVR : H'Ability Home

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

DEVICEControl: paper-based exercise guide

self-rehabilitation booklet used in current practice in centers


Locations(5)

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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NCT07202520


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