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

Association APPROCHE

Status: Enrolling

Conditions: Ischemic Stroke; Hemorrhagic Unilateral Cortico-subcortical Hemispheric Stroke

Treatments: Device: AutonHome® device

Study type: Interventional

Funder types: Other

Identifiers

NCT06443840

2023-A01298-37

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control group

No Intervention group

Description:

Participants will be randomised into a control group, undergoing conventional in-centre rehabilitation.

Experimental group

Experimental group

Description:

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.

Treatment:

Device: AutonHome® device