Status:
NOT_YET_RECRUITING
Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients
Lead Sponsor:
H'ability
Collaborating Sponsors:
Pôle Saint Hélier
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 wi...
Detailed Description
This is a prospective, multicenter, randomized, controlled, crossover, and repeated-measures clinical study. Patients with a first stroke, currently undergoing rehabilitation in a center with a plann...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07202520
Start Date
October 30 2025
End Date
September 29 2026
Last Update
October 1 2025
Active Locations (5)
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1
Fondation Hopale - Centre de Jacques Calvé
Berck, France, 62600
2
Hôpital Léon Bérard
Hyères, France, 83418
3
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de KERPAPE
Ploemeur, France, 56270
4
Pôle Saint Hélier
Rennes, France, 35043