StrokeNCT07202520
Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients
A study testing IVR : H'Ability Home in people with Stroke, run by H'ability at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- IVR : H'Ability Home
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesFrance
- Study dates
- 16 Dec 2025to 29 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Fondation Hopale - Centre de Jacques Calvé
Berck, 62600
Pascal RIGAUX, 0033 3 21 89 20 20, pascal.rigaux@fondation-hopale.org
Pascal RIGAUX
- Recruiting
Hôpital Léon Bérard
Hyères, 83418
Isabelle THIRY-ESCUDIE, 0033 4 94 38 19 43, i.thiry@leonberard.com
Isabelle THIRY-ESCUDIE
- Recruiting
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de KERPAPE
Ploemeur, 56270
Cécile DIOT, 0033 2 97 82 62 93, cecile.diot@vyv3.fr
Cécile DIOT
- Recruiting
Pôle Saint Hélier
Rennes, 35043
Emilie LEBLONG, MD, PhD, 0033 2 29 99 50 99, emilie.leblong@fondationsainthelier.com
Emilie LEBLONG
- Recruiting
Fondation ILDYS - Centre de Perharidy
Roscoff, 29684
Tanguy LE CORRE, 0033 2 98 29 39 39, tanguy.lecorre@ildys.org
Tanguy LE CORRE
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- IVR : H'Ability Home, Control: paper-based exercise guide
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR : H'Ability HomeDevice
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
Control: paper-based exercise guideDevice
Also called Control
self-rehabilitation booklet used in current practice in centers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Device: IVR : H'Ability Home; Device: Control: paper-based exercise guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
walking speed by the duration of the 10 meters of walking
Measured: 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.
coordination by the Quick-DASH score (DASH: Disabilities of the Arm, Shoulder and Hand). scored from 11 (no incapacity) to 100 (full incapacity)
Measured: 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.
quality of life by the EuroQoL-5D score. from 1 (no problem) to 5 (extreme problems)
Measured: 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.
satisfaction by the visual digital scale Satisfaction score. From 0 (total insatisfaction) to 10 (total satisfaction)
Measured: 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.
cognitive abilities by Mini-Mental State Examination score. From 0 (significant cognitive impairment) to 30 (optimal cognitive abilities)
Measured: 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.
fear of falling by the Short-Falls Efficacy Scale-International score scored from 7 (minimal fear) to 28 (maximal fear)
Measured: T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)
Describe patient compliance with both devices: H'Ability Home and exercise booklet.
compliance by number of connections or achievements
Measured: 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)
acceptability by the score of the Unified Theory of Acceptance and the Use of Technology dimensions. caregiver: from 28 (low acceptance) to 196 (high acceptance). patients: from 31 (low acceptance) to 217 (high acceptance)
Measured: 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
mental load by NASA Task Load Index score. from 0 (low cognitive load) to 100 (high cognitive load)
Measured: T2(week 6), T4 (week 13)
Describe the level of motion sickness associated with the use of the H'Ability Home virtual reality device
motion sickness by Simulator Sickness Questionnaire score. From 0 (no cinetose) to 48 (severe cinetose)
Measured: T2(week 6), T4 (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start16 Dec 2025
- Primary completion8 Aug 2027 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- H'ability
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pôle Saint Hélier
- Responsible party
- Sponsor
- Investigators
- Emilie LEBLONG, MD, PhD, Principal investigator, Pôle Saint Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202520
- Sponsor's protocol ID
- IVR-Home
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients
- ClinicalTrials.gov ID
- NCT07202520
- Acronym / sponsor ID
- IVR-Home
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- H'abilityIndustry (pharma, biotech, devices)
- Collaborators
- Pôle Saint Hélier
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 8 Aug 2027 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : IVR + Control | Other | Device: IVR : H'Ability Home, Device: Control: paper-based exercise guide6 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 |
| Arm 2 : Control + IVR | Other | Device: IVR : H'Ability Home, Device: Control: paper-based exercise guide6 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVR : H'Ability HomeH'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 | Arm 1 : IVR + Control, Arm 2 : Control + IVR |
| Control: paper-based exercise guideAlso: Controlself-rehabilitation booklet used in current practice in centers | Device | Arm 1 : IVR + Control, Arm 2 : Control + IVR |
Primary outcome
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)
Level of autonomy by the functional independence measure (FIM) score. From 18 (no autonomy) to 126 (full autonomy).
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilie LEBLONG, MD, PhD principal investigator
Pôle Saint Hélier
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR : H'Ability Home in people with Stroke, run by H'ability at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie LEBLONG, MD, PhD (0033 2 99 29 50 99, emilie.leblong@fondationsainthelier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.