Hemorrhagic Unilateral Cortico-subcortical Hemispheric Stroke, Ischemic Stroke
Conditions
Keywords
post-stroke, tele-rehabilitation, self-rehabilitation, AutonHome, medical device, Physical Medicine and Rehabilitation, Rehabilitation Medicine
Brief summary
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).
Interventions
DEVICEAutonHome® device
The experimental group will have to carry out the programme of self-rehabilitation and tele-rehabilitation with the AutonHome® device in addition to conventional rehabilitation.
Sponsors
Société Neuradom
IMT Atlantique Brest
Association APPROCHE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This protocol is carried out in accordance with the European Regulation 2017/745 on Medical Devices (MDR) and concerns a Class I medical device (MD) of category 4.2 (Article 82 MDR), corresponding to the CE marked MD used for its intended purpose without the objective of establishing conformity, and with an additional non-invasive and non-burdensome procedure. This is a comparative, prospective, multicenter study (4 centers), controlled, randomized, open-label, with 2 parallel arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | At 0 and 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the recovery of overall functional independence. | At 0, 6, 12 and 15 weeks | 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. |
| The recovery of a seated and standing postural balance, walking and mobility on the plane. | At 0, 6, 12 and 15 weeks | 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. |
| Achievement of objectives | At 0, 6, 12 and 15 weeks | 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). |
| Autonomy and social participation | At 0, 6, 12 and 15 weeks | 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). |
| Compliance with and duration of sessions and stays. | Every day during 15 weeks | Compliance (present at the session) : Yes/No |
| The perception of the effort at each session | Every day during 15 weeks | Borg scale : The Borg scale is generally rated from 6 to 20. The higher the number, the more intense the perceived effort. |
| The perceived experience of the session. | Every day during 15 weeks | Perceived experience of the rehabilitation session in response to the following 4 questions with a scoring that comes in 5 different levels depending on the question : What is the patient's perception of the rehabilitation session offered? Very poor - Poor - No effect - Positive - Very positive What is the patient's perception of the quality of the exercises proposed? Very poor - Poor - No effect - Positive - Very positive What is the patient's perception of the intensity of the exercises proposed? Very poor - Poor - No effect - Positive - Very positive What is the patient's perception of the motivating nature of the exercises proposed? Very poor - Poor - No effect - Positive - Very positive |
| Study the medium-term appropriation of the selfrehabilitation system by the participants. | At 0, 6, 12 and 15 weeks | SUS (System Usability Scale) : only for the experimental groups. The SUS consists of 10 questions in the form of statements. Each question uses a Likert scale, where the user chooses between 5 possible answers, ranging from 'Strongly disagree' to 'Strongly agree'. The answers to the 10 questions are used to construct a satisfaction score, ranging from 1 to 100. In general, a score of 75 or more is considered 'good', while between 50 and 75 it is considered 'fair' or 'correct'. A score of less than 50 indicates major problems in terms of customer satisfaction. |
| Compare the costs of the experimental care pathway to the costs of a conventional care pathway | Every day during 15 weeks | Study of direct and indirect costs |
| The risk of adverse effects | Every day during 15 weeks | Number of falls |
Countries
France
Contacts
Primary ContactMarie-Caroline Delebecque, CRA
Backup ContactPauline Coignard, Doctor
Outcome results
None listed