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. * 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
44
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
self-rehabilitation booklet used in current practice in centers
Fondation Hopale - Centre de Jacques Calvé
Berck, France
RECRUITINGHôpital Léon Bérard
Hyères, France
RECRUITINGCentre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de KERPAPE
Ploemeur, France
RECRUITINGPôle Saint Hélier
Rennes, France
RECRUITINGFondation ILDYS - Centre de Perharidy
Roscoff, France
RECRUITINGTo 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).
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 walking speed of post-stroke patients compared to the exercise booklet.
walking speed by the duration of the 10 meters of walking
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.
coordination by the Quick-DASH score (DASH: Disabilities of the Arm, Shoulder and Hand). scored from 11 (no incapacity) to 100 (full incapacity)
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.
quality of life by the EuroQoL-5D score. from 1 (no problem) to 5 (extreme problems)
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.
satisfaction by the visual digital scale Satisfaction score. From 0 (total insatisfaction) to 10 (total satisfaction)
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.
cognitive abilities by Mini-Mental State Examination score. From 0 (significant cognitive impairment) to 30 (optimal cognitive abilities)
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.
fear of falling by the Short-Falls Efficacy Scale-International score scored from 7 (minimal fear) to 28 (maximal fear)
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.
compliance by number of connections or achievements
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)
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)
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
mental load by NASA Task Load Index score. from 0 (low cognitive load) to 100 (high cognitive load)
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
motion sickness by Simulator Sickness Questionnaire score. From 0 (no cinetose) to 48 (severe cinetose)
Time frame: T2(week 6), T4 (week 13)
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