Clinical trial NCT06443840: Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway
Official title: AUTONHOME: Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway : Preliminary Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemorrhagic Unilateral Cortico-subcortical Hemispheric Stroke
Ischemic Stroke
Keywords: post-stroke
tele-rehabilitation
self-rehabilitation
AutonHome
medical device
Physical Medicine and Rehabilitation
Rehabilitation Medicine
Lead sponsor: Association APPROCHE
Sponsor class: OTHER
Collaborators: name: Société Neuradom
name: IMT Atlantique Brest
First posted: 2024-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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).


Eligibility criteria: 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 \&gt; 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

Primary outcomes:
measure: 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.
timeFrame: At 0 and 6 weeks
Secondary outcomes:
measure: Evaluate the recovery of overall functional independence.
timeFrame: At 0, 6, 12 and 15 weeks
measure: The recovery of a seated and standing postural balance, walking and mobility on the plane.
timeFrame: At 0, 6, 12 and 15 weeks
measure: The recovery of a seated and standing postural balance, walking and mobility on the plane.
timeFrame: At 0, 6, 12 and 15 weeks
measure: The recovery of a seated and standing postural balance, walking and mobility on the plane.
timeFrame: At 0, 6, 12 and 15 weeks
measure: Achievement of objectives
timeFrame: At 0, 6, 12 and 15 weeks
measure: Autonomy and social participation
timeFrame: At 0, 6, 12 and 15 weeks
measure: The risk of adverse effects
timeFrame: Every day during 15 weeks
measure: The risk of adverse effects
timeFrame: Every day during 15 weeks
measure: The risk of adverse effects
timeFrame: Every day during 15 weeks
measure: The perception of the effort at each session
timeFrame: Every day during 15 weeks
measure: The perceived experience of the session.
timeFrame: Every day during 15 weeks
measure: The perceived experience of the session.
timeFrame: Every day during 15 weeks
measure: Compliance with and duration of sessions and stays.
timeFrame: Every day during 15 weeks
measure: Compliance with and duration of sessions and stays.
timeFrame: Every day during 15 weeks
measure: Compliance with and duration of sessions and stays.
timeFrame: Every day during 15 weeks
measure: Compliance with and duration of sessions and stays.
timeFrame: Every day during 15 weeks
measure: Compliance with and duration of sessions and stays.
timeFrame: Every day during 15 weeks
measure: Study the medium-term appropriation of the selfrehabilitation system by the participants.
timeFrame: At 0, 6, 12 and 15 weeks
measure: Compare the costs of the experimental care pathway to the costs of a conventional care pathway
timeFrame: Every day during 15 weeks
Other outcomes:
Locations:
city: Brest
country: France
facility: Fondation Ildys
state: Bretagne
city: Ploemeur
country: France
facility: CMRRF de Kerpape
state: Bretagne
city: Rennes
country: France
facility: Association Saint-Hélier
state: Bretagne
city: Perpignan
country: France
facility: Centre Bouffard Vercelli - USSAP
state: Pyrénées-Orientales
Study officials:
References:
citation: RAOULT, Bérengère, PONTIER, Joanna, FICHEUX, Gilles and FATTAL, Charles, 2020. Étude de faisabilité d'un parcours d'auto-rééducation de patients hémiplégiques. Kinésithérapie Scientifique. Décembre 2020. No. 626, p. 5-13.