Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway
Launched by ASSOCIATION APPROCHE · May 30, 2024
Trial Information
Current as of February 18, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called the AutonHome® study, is investigating how a new self-rehabilitation and tele-rehabilitation program can help patients recover after having a stroke. The study looks at two types of strokes: hemorrhagic and ischemic. It aims to find out if using a special device, called AutonHome®, along with regular rehabilitation can improve recovery for stroke patients. This device allows patients to follow personalized rehabilitation exercises at home, guided by their therapist, which means they won’t need to travel to a clinic as often. The goal is to show that this combination of self-care and traditional therapy helps patients recover better and faster.
To participate in this study, individuals must be between the ages of 18 and 85 and have had a recent stroke within the last 30 days. They should also show certain levels of physical ability and cognitive function. Participants will be divided into two groups: one will receive standard rehabilitation at a center, while the other will use the AutonHome® device along with their standard care. The study will last for 15 weeks, and participants can expect to contribute to important research that could improve stroke recovery methods for many people in the future.
Gender
ALL
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
About Association Approche
Association Approche is a dedicated clinical trial sponsor committed to advancing healthcare through innovative research and development. By fostering collaboration among healthcare professionals, researchers, and patients, the organization aims to facilitate the design and execution of high-quality clinical studies that address unmet medical needs. With a focus on ethical practices and patient safety, Association Approche utilizes a robust framework to ensure the integrity and reliability of trial outcomes, ultimately contributing to the development of effective treatments and therapies in various therapeutic areas.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brest, Bretagne, France
Ploemeur, Bretagne, France
Rennes, Bretagne, France
Perpignan, Pyrénées Orientales, France
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0