Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients
NCT ID: NCT07202520
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
44 participants
INTERVENTIONAL
2025-10-30
2026-09-29
Brief Summary
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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.
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Detailed Description
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Patients 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.
After inclusion, patients will be randomized to one of two study arms.
* Arm 1: Experimental phase / Washout / Control phase
* Arm 2: Control phase / Washout phase / Experimental phase
During the experimental phase, patients will perform their self-rehabilitation exercises at home using the H'Ability Home device for six weeks.
During 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm 1 : IVR + Control
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
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
Arm 2 : Control + IVR
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)
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pôle Saint Hélier
OTHER
H'ability
INDUSTRY
Responsible Party
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Principal Investigators
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Emilie LEBLONG, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Pôle Saint Hélier
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IVR-Home
Identifier Type: -
Identifier Source: org_study_id
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