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

NCT07202520 | Not Yet Recruiting

• 1 other identifier: IVR-Home
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• To evaluate the impact of the H'Ability Home device on the level of autonomy of post-stroke patients compared to the exercise booklet.

  Level of autonomy by the functional independence measure (FIM) score. From 18 (no autonomy) to 126 (full autonomy).

  T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)

Secondary Outcomes (10)

• To evaluate the impact of the H'Ability Home device on the walking speed of post-stroke patients compared to the exercise booklet.

  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.

  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.

  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.

  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.

  T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)

Study Arms (2)

Arm 1 : IVR + Control

OTHER

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

Device: IVR : H'Ability Home; Device: Control: paper-based exercise guide

Arm 2 : Control + IVR

OTHER

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)

Device: IVR : H'Ability Home; Device: Control: paper-based exercise guide

Interventions

IVR : H'Ability Home DEVICE

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

Arm 1 : IVR + Control; Arm 2 : Control + IVR

Control: paper-based exercise guide DEVICE

self-rehabilitation booklet used in current practice in centers

Also known as: Control

Arm 1 : IVR + Control; Arm 2 : Control + IVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

Sponsors & Collaborators

• H'ability: lead
• Pôle Saint Hélier: collaborator

Study Sites (5)

Fondation Hopale - Centre de Jacques Calvé

Berck, 62600, France

Location

Hôpital Léon Bérard

Hyères, 83418, France

Location

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de KERPAPE

Ploemeur, 56270, France

Location

Pôle Saint Hélier

Rennes, 35043, France

Location

Fondation ILDYS - Centre de Perharidy

Roscoff, 29684, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Emilie LEBLONG, MD, PhD

  Pôle Saint Hélier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie LEBLONG, MD, PhD

CONTACT

0033 2 99 29 50 99; emilie.leblong@fondationsainthelier.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: After screening visit, patients are randomised between two Arms. Patients in Arm 1 start with experimental phase (H'Ability Home) and after a wash-out period start the control phase (paper). Patients randomised in Arm 2 start with the control phase and after the wash-out period start the experimental phase.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: October 1, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): August 8, 2026
• Study Completion (Estimated): September 29, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)