Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443840
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-14
Brief Title:
Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway
Sponsor:
Association APPROCHE
Organization:
Association APPROCHE
Study Overview
Official Title:
AUTONHOME Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway Preliminary Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AUTONHOME
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 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 Neuradoms 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 11 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
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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None