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

NCT06443840 | Recruiting

• 1 other identifier: 2023-A01298-37
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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. 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

Hemorrhagic Unilateral Cortico-subcortical Hemispheric Stroke; Ischemic Stroke

Keywords

post-stroke; tele-rehabilitation; self-rehabilitation; AutonHome; medical device; Physical Medicine and Rehabilitation; Rehabilitation Medicine

Outcome Measures

Primary Outcomes (1)

• Evaluate the non-inferiority of the experimental course of care, on the technical platform and at home, on the evolution of sensory-motor recovery, compared to the control course.

  Change in Fugl-Meyer score between inclusion on Day 0 and the visit on Day 45 (Week 6) Minimum = 0 Maximum = 100 However, as an exploratory secondary endpoint (objective 1a), the sub-scores for the upper limb (UL) and lower limb (LL) will be studied separately, as well as changes at 12 weeks (D80) and 15 weeks (D105). * Upper limb / 66 * Lower limb / 34 Total / 100 The higher the Fugl Meyer score, the better the sensory-motor recovery. The Fugl Meyer scores will then be compared between the experimental course (on the technical platform and at home) and the control course.

  At 0 and 6 weeks

Secondary Outcomes (19)

• Evaluate the recovery of overall functional independence.

  At 0, 6, 12 and 15 weeks

• The recovery of a seated and standing postural balance, walking and mobility on the plane.

  At 0, 6, 12 and 15 weeks

• The recovery of a seated and standing postural balance, walking and mobility on the plane.

  At 0, 6, 12 and 15 weeks

• The recovery of a seated and standing postural balance, walking and mobility on the plane.

  At 0, 6, 12 and 15 weeks

• Achievement of objectives

  At 0, 6, 12 and 15 weeks

Study Arms (2)

Control group

NO INTERVENTION

Participants will be randomised into a control group, undergoing conventional in-centre rehabilitation.

Experimental group

EXPERIMENTAL

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.

Device: AutonHome® device

Interventions

AutonHome® device 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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years ≤ age ≤ 85 years,
• st 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association APPROCHE: lead
• Société Neuradom: collaborator
• IMT Atlantique Brest: collaborator

Study Sites (4)

Fondation Ildys

Brest, Brittany Region, 29684, France

NOT YET RECRUITING

CMRRF de Kerpape

Ploemeur, Brittany Region, 56275, France

NOT YET RECRUITING

Association Saint-Hélier

Rennes, Brittany Region, 35043, France

NOT YET RECRUITING

Centre Bouffard Vercelli - USSAP

Perpignan, Pyrénées-Orientales, France

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Marie-Caroline Delebecque, CRA

CONTACT

0297826174; approche@mutualite29-56.fr

Pauline Coignard, Doctor

CONTACT

0297826060; pauline.coignard@vyv3.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This protocol is carried out in accordance with the European Regulation 2017/745 on Medical Devices (MDR) and concerns a Class I medical device (MD) of category 4.2 (Article 82 MDR), corresponding to the CE marked MD used for its intended purpose without the objective of establishing conformity, and with an additional non-invasive and non-burdensome procedure. This is a comparative, prospective, multicenter study (4 centers), controlled, randomized, open-label, with 2 parallel arms.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 5, 2024
• Study Start: May 6, 2024
• Primary Completion: October 1, 2025
• Study Completion: March 1, 2026
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

FR (4)