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NCT07202520Toboroz

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 22.

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Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
44 (tervezett)
Első benyújtás
2025. aug. 8.
Kezdés
2025. dec. 16.
Elsődleges befejezés
2027. aug. 8.
Fő szponzor
H'ability
NCT-szám
NCT07202520

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 44
  • 2025. dec. 16. és az elsődleges befejezés (2027. aug. 8.) között
  • 5 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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A regiszterben nem jelölt feltételek

  • 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

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (5)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Fondation Hopale - Centre de Jacques CalvéBerckFranciaországToboroz
Hôpital Léon BérardHyèresFranciaországToboroz
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de KERPAPEPloemeurFranciaországToboroz
Pôle Saint HélierRennesFranciaországToboroz
Fondation ILDYS - Centre de PerharidyRoscoffFranciaországToboroz

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