Actively Recruiting
Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway
Led by Association APPROCHE · Updated on 2024-06-05
40
Participants Needed
4
Research Sites
94 weeks
Total Duration
On this page
Sponsors
A
Association APPROCHE
Lead Sponsor
S
Société Neuradom
Collaborating Sponsor
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Age between 18 and 85 years
- First recent ischemic or hemorrhagic unilateral cortico-subcortical hemispheric stroke
- Minimum post-stroke delay of 7 days
- Maximum post-stroke delay of 30 days
- SOFMER category 2 moderate strokes with NIHSS score between 5 and 14
- MoCA score greater than 23
You will not qualify if you...
- Participant deprived of liberty by judicial or administrative decision
- Adult participant under legal protection or unable to provide consent
- Participation in another ongoing clinical trial
- Pregnant or breastfeeding women or women of childbearing age without effective contraception
- Lack of command of oral and written French language
- Pre-existing neurological pathology
- Severe expression aphasia affecting intelligibility
- Severe comprehension aphasia
- Major cognitive disorders such as dementia or post-dementia
- Unstable psychiatric disorders
- Unstabilized medical pathology
- Unbalanced epilepsy
- Color blindness
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Fondation Ildys
Brest, Brittany Region, France, 29684
Not Yet Recruiting
2
CMRRF de Kerpape
Ploemeur, Brittany Region, France, 56275
Not Yet Recruiting
3
Association Saint-Hélier
Rennes, Brittany Region, France, 35043
Not Yet Recruiting
4
Centre Bouffard Vercelli - USSAP
Perpignan, Pyrénées-Orientales, France
Actively Recruiting
Research Team
M
Marie-Caroline Delebecque, CRA
CONTACT
P
Pauline Coignard, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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