Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients

Обзор

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.

Подробное описание

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 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.

Вмешательства

• Устройство 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
• Устройство Control: paper-based exercise guide
  self-rehabilitation booklet used in current practice in centers

Первичные конечные точки

• To evaluate the impact of the H'Ability Home device on the level of autonomy of post-stroke patients compared to the exercise booklet. [Срок оценки: T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)]

Вторичные конечные точки (10)

• To evaluate the impact of the H'Ability Home device on the walking speed of post-stroke patients compared to the exercise booklet. [Срок оценки: T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)]
• To evaluate the impact of the H'Ability Home device on the coordination of post-stroke patients compared to the exercise booklet. [Срок оценки: T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)]
• To evaluate the impact of the H'Ability Home device on the quality of life of post-stroke patients compared to the exercise booklet. [Срок оценки: T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)]
• Evaluate the impact of the H'Ability Home device on satisfaction with rehabilitation exercises in post-stroke patients compared to the exercise booklet. [Срок оценки: T2(week 6), T4 (week 13)]
• To evaluate the effect of the H'Ability Home device on the cognitive abilities of post-stroke patients compared to the exercise booklet. [Срок оценки: T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)]
• Evaluate the impact of the H'Ability Home device on the fear of falling in relation to the exercise booklet. [Срок оценки: T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)]
• Describe patient compliance with both devices: H'Ability Home and exercise booklet. [Срок оценки: T2(week 6), T4 (week 13)]
• Evaluate the acceptability of the H'Ability Home device among patients and caregivers before use (a priori acceptability) and after use (a posteriori acceptability) [Срок оценки: T0 (screening), T2(week 6), T4 (week 13)]
• Describe the level of mental load of patients with the two devices: H'Ability Home and exercise booklet [Срок оценки: T2(week 6), T4 (week 13)]
• Describe the level of motion sickness associated with the use of the H'Ability Home virtual reality device [Срок оценки: T2(week 6), T4 (week 13)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 5 центров

• Fondation Hopale - Centre de Jacques Calvé — Berck
• Hôpital Léon Bérard — Hyères
• Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de KERPAPE — Ploemeur
• Pôle Saint Hélier — Rennes
• Fondation ILDYS - Centre de Perharidy — Roscoff

Идентификаторы

NCT: NCT07202520 · IVR-Home

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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