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Not yet recruiting NCT07202520

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IVR : H'Ability Home, Control: paper-based exercise guide.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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 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.

Interventions

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

Primary outcome measures

  • To evaluate the impact of the H'Ability Home device on the level of autonomy of post-stroke patients compared to the exercise booklet. [Time frame: T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)]
Secondary outcome measures (10)
  • To evaluate the impact of the H'Ability Home device on the walking speed of post-stroke patients compared to the exercise booklet. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)]
  • Describe patient compliance with both devices: H'Ability Home and exercise booklet. [Time frame: 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) [Time frame: 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 [Time frame: T2(week 6), T4 (week 13)]
  • Describe the level of motion sickness associated with the use of the H'Ability Home virtual reality device [Time frame: T2(week 6), T4 (week 13)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Supportive care

Study locations

France · 5 centers
  • 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

Identifiers

NCT: NCT07202520 · IVR-Home

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗