Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway
NCT ID: NCT06443840
Last Updated: 2024-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-05-06
2026-03-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
This is a comparative, prospective, multicenter study (4 centers), controlled, randomized, open-label, with 2 parallel arms.
OTHER
NONE
Study Groups
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Control group
Participants will be randomised into a control group, undergoing conventional in-centre rehabilitation.
No interventions assigned to this group
Experimental group
The experimental group will have to carry out the programme of self-rehabilitation and tele-rehabilitation with the AutonHome® device in addition to conventional rehabilitation.
AutonHome® device
The experimental group will have to carry out the programme of self-rehabilitation and tele-rehabilitation with the AutonHome® device in addition to conventional rehabilitation.
Interventions
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AutonHome® device
The experimental group will have to carry out the programme of self-rehabilitation and tele-rehabilitation with the AutonHome® device in addition to conventional rehabilitation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Société Neuradom
UNKNOWN
IMT Atlantique Brest
UNKNOWN
Association APPROCHE
OTHER
Responsible Party
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Locations
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Fondation Ildys
Brest, Brittany Region, France
CMRRF de Kerpape
Ploemeur, Brittany Region, France
Association Saint-Hélier
Rennes, Brittany Region, France
Centre Bouffard Vercelli - USSAP
Perpignan, Pyrénées-Orientales, France
Countries
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Central Contacts
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Facility Contacts
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References
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RAOULT, Bérengère, PONTIER, Joanna, FICHEUX, Gilles and FATTAL, Charles, 2020. Étude de faisabilité d'un parcours d'auto-rééducation de patients hémiplégiques. Kinésithérapie Scientifique. Décembre 2020. No. 626, p. 5-13.
Other Identifiers
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2023-A01298-37
Identifier Type: -
Identifier Source: org_study_id
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