Stroke
Conditions
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.
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
DEVICEIVR : 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
DEVICEControl: paper-based exercise guide
self-rehabilitation booklet used in current practice in centers
Sponsors
Pôle Saint Hélier
H'ability
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the impact of the H'Ability Home device on the level of autonomy of post-stroke patients compared to the exercise booklet. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | coordination by the Quick-DASH score (DASH: Disabilities of the Arm, Shoulder and Hand). scored from 11 (no incapacity) to 100 (full incapacity) |
| 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) | quality of life by the EuroQoL-5D score. from 1 (no problem) to 5 (extreme problems) |
| 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) | satisfaction by the visual digital scale Satisfaction score. From 0 (total insatisfaction) to 10 (total satisfaction) |
| 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) | cognitive abilities by Mini-Mental State Examination score. From 0 (significant cognitive impairment) to 30 (optimal cognitive abilities) |
| 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) | walking speed by the duration of the 10 meters of walking |
| Describe patient compliance with both devices: H'Ability Home and exercise booklet. | T2(week 6), T4 (week 13) | compliance by number of connections or achievements |
| Evaluate the acceptability of the H'Ability Home device among patients and caregivers before use (a priori acceptability) and after use (a posteriori acceptability) | T0 (screening), T2(week 6), T4 (week 13) | 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) |
| Describe the level of mental load of patients with the two devices: H'Ability Home and exercise booklet | T2(week 6), T4 (week 13) | mental load by NASA Task Load Index score. from 0 (low cognitive load) to 100 (high cognitive load) |
| Describe the level of motion sickness associated with the use of the H'Ability Home virtual reality device | T2(week 6), T4 (week 13) | motion sickness by Simulator Sickness Questionnaire score. From 0 (no cinetose) to 48 (severe cinetose) |
| Evaluate the impact of the H'Ability Home device on the fear of falling in relation to the exercise booklet. | T1(Baseline), T2(week 6), T3(week 7), T4 (week 13) | fear of falling by the Short-Falls Efficacy Scale-International score scored from 7 (minimal fear) to 28 (maximal fear) |
Countries
France
Contacts
Primary ContactEmilie LEBLONG, MD, PhD
Outcome results
None listed