Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT07202520
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07202520
Study Brief:
Protocol Section:
NCT07202520