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| Name | Class |
|---|---|
| Pôle Saint Hélier | OTHER |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Patient Inclusion Criteria:
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.
Third-party family caregiver Inclusion Criteria:
Third-party family caregiver non-inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie LEBLONG, MD, PhD | Contact | 0033 2 99 29 50 99 | emilie.leblong@fondationsainthelier.com |
| Name | Affiliation | Role |
|---|---|---|
| Emilie LEBLONG, MD, PhD | Pôle Saint Hélier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondation Hopale - Centre de Jacques Calvé | Berck | 62600 | France |
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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.
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| Control: paper-based exercise guide | Device | self-rehabilitation booklet used in current practice in centers |
|
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coordination by the Quick-DASH score (DASH: Disabilities of the Arm, Shoulder and Hand). scored from 11 (no incapacity) to 100 (full incapacity) |
| 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | T2(week 6), T4 (week 13) |
| Hôpital Léon Bérard | Hyères | 83418 | France |
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| Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de KERPAPE | Ploemeur | 56270 | France |
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| Pôle Saint Hélier | Rennes | 35043 | France |
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| Fondation ILDYS - Centre de Perharidy | Roscoff | 29684 | France |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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