Recruiting
Not applicable
Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients
Condition(s) studied
Stroke
Investigational drug(s) / intervention(s)
IVR : H'Ability HomeControl: paper-based exercise guide
IVR : 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
Control: paper-based exercise guide: self-rehabilitation booklet used in current practice in centers
Study 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
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
Primary outcome measure(s)
- To evaluate the impact of the H'Ability Home device on the level of autonomy of post-stroke patients compared to the exercise booklet. — T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)
Level of autonomy by the functional independence measure (FIM) score. From 18 (no autonomy) to 126 (full autonomy).
Trial sites (5)
| Facility | City | Region | Status |
| Fondation Hopale - Centre de Jacques Calvé |
Berck |
France |
Recruiting |
| Hôpital Léon Bérard |
Hyères |
France |
Recruiting |
| Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de KERPAPE |
Ploemeur |
France |
Recruiting |
| Pôle Saint Hélier |
Rennes |
France |
Recruiting |
| Fondation ILDYS - Centre de Perharidy |
Roscoff |
France |
Recruiting |
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