Status:
RECRUITING
Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway
Lead Sponsor:
Association APPROCHE
Collaborating Sponsors:
Société Neuradom
IMT Atlantique Brest
Conditions:
Hemorrhagic Unilateral Cortico-subcortical Hemispheric Stroke
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
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® selfeduca...
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 > 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
Key Trial Info
Start Date :
May 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06443840
Start Date
May 6 2024
End Date
March 1 2026
Last Update
June 5 2024
Active Locations (4)
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1
Fondation Ildys
Brest, Brittany Region, France, 29684
2
CMRRF de Kerpape
Ploemeur, Brittany Region, France, 56275
3
Association Saint-Hélier
Rennes, Brittany Region, France, 35043
4
Centre Bouffard Vercelli - USSAP
Perpignan, Pyrénées-Orientales, France