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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Page 1 of 1 (4 locations)

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

Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway | DecenTrialz