Using a device for self-rehabilitation and tele-rehabilitation after stroke
AUTONHOME: Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway : Preliminary Study
This study tests if a new device can help people recovering from a stroke do their rehab at home with support from their therapists.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Association APPROCHE Academic / other |
| Locations | 4 sites (Brest, Brittany Region and 3 other locations) |
| Trial ID | NCT06443840 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the effectiveness of the AutonHome® device, which facilitates self-education and telecare for patients recovering from a cerebrovascular accident (CVA). The device allows patients to engage in personalized rehabilitation programs under the supervision of their therapists, thereby maintaining a therapeutic connection without the need for travel. The study targets individuals who have experienced a recent ischemic or hemorrhagic stroke and assesses the usability and perceived benefits of the device in enhancing post-stroke rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 who have experienced a recent unilateral cortico-subcortical stroke and meet specific neurological assessment criteria.
Not a fit: Patients who are unable to provide consent or are currently involved in another clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve rehabilitation outcomes for stroke patients by providing accessible and personalized care.
How similar studies have performed: Previous studies have shown the feasibility and perceived usefulness of similar self-education programs for stroke rehabilitation, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 \> 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
Where this trial is running
Brest, Brittany Region and 3 other locations
- 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)
Study contacts
- Study coordinator: Marie-Caroline Delebecque, CRA
- Email: approche@mutualite29-56.fr
- Phone: 0297826174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.