Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway

Association APPROCHE40 enrolled

Overview

The AutonHome® clinical investigation, proposed by Dr Charles FATTAL (coordinator of this study), and carried out by the Association Approche (delegated promoter), aims to use the AutonHome® selfeducation device for the rehabilitation of patients who have suffered a Cerebrovascular Accident (CVA), and thus respond to the problems of therapeutic discontinuity highlighted today. Neuradom's AutonHome® device combines self-education and telecare. This device makes it possible to carry out personalised self-education programmes supervised by the therapist, enabling the therapeutic link with the patient to be maintained without the need for the patient to travel. This tool has already proved its usability and perceived usefulness in a previous clinical study, which demonstrated the feasibility of a self-education programme for hemiplegic patients, based on feedback. AutonHome® was considered by users to be a relevant, useful and safe complement to conventional rehabilitation. On the basis of this feasibility study, the investigators wished to develop a second study around this AutonHome® device. In this second clinical investigation, in addition to perceived usefulness, the main objective is to demonstrate, in a population of stroke victims, that an experimental care pathway combining supervised self-education via AutonHome® with conventional re-education optimises the care pathway in terms of sensory-motor recovery, but also in terms of reduced length of stay and functional and medico-economic added value. This clinical trial involves two parallel arms. Participants will be randomised into a control group, undergoing conventional in-centre rehabilitation, or into an experimental group, with self-rehabilitation and tele-rehabilitation in addition to conventional rehabilitation. The AutonHome study is a pilot study, with the aim of including 40 participants. Each centre will recruit 10 participants on a 1:1 randomisation basis, with 5 in the experimental group and 5 in the control group. Participants will be monitored for 15 weeks. This clinical investigation is multicentre, with 4 centres involved: the Centre Bouffard Vercelli (66962, Perpignan), the CMRRF de Kerpape (56275 Ploemeur), the association Saint-Hélier (35043, Rennes), and the Fondation ILDYS (29684 Roscoff).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants who signed the written consent form to participate in the study after free and informed information * Participants affiliated to a social security scheme (beneficiary or beneficiary) outside the AME. * 18 years ≤ age ≤ 85 years, * 1st recent ischemic or hemorrhagic unilateral cortico-subcortical hemispheric stroke * Minimum post-stroke delay: 7 days * Maximum post-stroke delay : 30 days * SOFMER category 2: moderate strokes called category 2 according to SOFMER with an NIHSS (initial score of the National Institute of Health Stroke Scale) between 5 and 14 (Several deficiencies or motor deficit of the lower limb prohibiting walking, with recovery potential, a probable autonomy project (unilateral stroke). * MoCA \> 23 Exclusion Criteria: * Participant deprived of liberty (by judicial or administrative decision) * Adult participant subject to a legal protection measure or unable to express their consent * Participation in another ongoing clinical trial * Pregnant or breastfeeding women or women of childbearing age without effective contraception * Lack of command of the oral and written French language * Pre-existing neurological pathology * Severe expression disorders (expression aphasia) affecting intelligibility * Severe comprehension disorders (comprehension aphasia) * Major cognitive disorders of the dementia or post-dementia type * Unstable psychiatric disorders * Unstabilized medical pathology * Unbalanced epilepsy * Color blindness

Locations (4)

Fondation Ildys

Brest, Brittany Region, France

NOT_YET_RECRUITING

CMRRF de Kerpape

Ploemeur, Brittany Region, France

NOT_YET_RECRUITING

Association Saint-Hélier

Rennes, Brittany Region, France

NOT_YET_RECRUITING

Centre Bouffard Vercelli - USSAP

Perpignan, Pyrénées-Orientales, France

RECRUITING

Outcomes

Primary Outcomes

Evaluate the non-inferiority of the experimental course of care, on the technical platform and at home, on the evolution of sensory-motor recovery, compared to the control course.

Change in Fugl-Meyer score between inclusion on Day 0 and the visit on Day 45 (Week 6) Minimum = 0 Maximum = 100 However, as an exploratory secondary endpoint (objective 1a), the sub-scores for the upper limb (UL) and lower limb (LL) will be studied separately, as well as changes at 12 weeks (D80) and 15 weeks (D105). * Upper limb / 66 * Lower limb / 34 Total / 100 The higher the Fugl Meyer score, the better the sensory-motor recovery. The Fugl Meyer scores will then be compared between the experimental course (on the technical platform and at home) and the control course.

Time frame: At 0 and 6 weeks

Secondary Outcomes

Evaluate the recovery of overall functional independence.

Functional independence measure - MIF Independence : 7: Complete independence (appropriate to circumstances and safe) 6: Modified independence (device, adaptation) Modified dependence : 5: Supervision 4: Minimal assistance (autonomy = 75% +) 3 : Average assistance (autonomy = 50% +) Complete dependence 2 : Maximum assistance (autonomy = 25% +) If an item cannot be checked, tick level 1. At the end of the test, we obtain a score ranging from 18 to 126. The lower the score, the greater the disability.

Time frame: At 0, 6, 12 and 15 weeks

The recovery of a seated and standing postural balance, walking and mobility on the plane.

Berg balance scale : The Berg balance assessment scale was developed to measure static and dynamic balance in adults. This scale comprises 14 tasks rated from 0 to 4, assessing both static and dynamic balance. The total score ranges from 0 to 56 points. The higher the score, the better the assessment of balance.

Time frame: At 0, 6, 12 and 15 weeks

The recovery of a seated and standing postural balance, walking and mobility on the plane.

6min walk test (6MWT) : The six-minute walk test (6MWT) is an objective assessment of functional physical ability. It measures the distance covered by the patient when walking briskly for 6 minutes. The 6MWT provides a global assessment of various organ functions, in particular the cardiopulmonary, vascular and neuromuscular systems. Distance covered: The distance covered during the test is the main parameter measured. In general, a longer distance indicates better functional capacity. Here are some approximate reference values: Normal: Approximately 400 to 700 metres. Poor: Less than 300 metres. Very good: Over 800 metres.

Time frame: At 0, 6, 12 and 15 weeks

The recovery of a seated and standing postural balance, walking and mobility on the plane.

10-metre walk test (10MWT) : The 10-metre walk test is an assessment tool that measures a patient's walking speed. It aims to calculate the speed at which a patient can walk a distance of 10 metres. The walking speed obtained can be used to classify the patient into different categories: Less than 0.4 m/s: Walking at home. Between 0.4 and 0.8 m/s: Limited walking in the community. More than 0.8 m/s: Unlimited walking in the community.

Time frame: At 0, 6, 12 and 15 weeks

Achievement of objectives

GAS (Goal Attainment Scaling) : The GAS is a tool for defining specific, individualised objectives for each patient. These objectives are then evaluated in a standardised way, allowing statistical analysis of the results. At least 3 objectives are set and scored between -3 (regression), -2 (much less), -1 (a little less), 0 (expected result), +1 (a little more), +2 (much more).

Time frame: At 0, 6, 12 and 15 weeks

Autonomy and social participation

IPA Scale (Impact on Participation and Autonomy Questionnaire) : * Level of participation perceived by the participant through 32 items spread over 5 domains related to autonomy in activities inside the home (7 items), family roles (7 items), activities outside (5 items), social life and relationships (7 items), work and education (6 items). The last 6 are excluded. Score from 0 (very low level of participation) to 4 (very high level). * Level of perception of participation restriction: Score of 0 (major problem), 1 (minor problem), 2 (no problem).

Time frame: At 0, 6, 12 and 15 weeks

The risk of adverse effects

Number of falls