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Hemorrhagic Unilateral Cortico-subcortical Hemispheric StrokeAUTONHOMENCT06443840

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

A study testing AutonHome® device in people with Hemorrhagic Unilateral Cortico-subcortical Hemispheric Stroke and Ischemic Stroke, run by Association APPROCHE at 4 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
AutonHome® device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesFrance
Study dates
6 May 2024to Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Marie-Caroline Delebecque, CRA contact

0297826174 ext. +33

approche@mutualite29-56.fr

Pauline Coignard, Doctor contact

0297826060 ext. +33

pauline.coignard@vyv3.fr

France4 sites, 4 recruiting
  • Fondation Ildys

    Brest, Brittany Region, 29684

    Patricia Bourgogne, Doctor, 0298293939 ext. +33, patricia.bourgogne@ildys.org

    Not yet recruiting
  • Centre Bouffard Vercelli - USSAP

    Perpignan, Pyrénées-Orientales

    Charles Fattal, Doctor, 0430441100 ext. +33, cfattal@ussap.fr

    Recruiting
  • CMRRF de Kerpape

    Ploemeur, Brittany Region, 56275

    Thibaud Honore, Doctor, 0297826060 ext. +33, thibaud.honore@vyv3.fr

    Juliette Sainson, CRA, 0297826293 ext. +33, juliette.sainson@vyv3.fr

    Not yet recruiting
  • Association Saint-Hélier

    Rennes, Brittany Region, 35043

    Emilie Leblong, Doctor, 0299295099 ext. +33, emilie.leblong@pole-sthelier.com

    Linda Bodet, CRA, 0299295043 ext. +33, linda.bodet@pole-sthelier.com

    Not yet recruiting

Other trials in France

About this study

Official title: AUTONHOME: Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway : Preliminary Study

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).

Being tested
AutonHome® device
Keywords
post-stroke, tele-rehabilitation, self-rehabilitation, AutonHome, medical device, Physical Medicine and Rehabilitation, Rehabilitation Medicine
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AutonHome® deviceDevice

    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.

Study groups in NCT06443840
Study groupRoleWhat they receive
Control groupNo interventionParticipants will be randomised into a control group, undergoing conventional in-centre rehabilitation.
Experimental groupExperimentalThe experimental group will have to carry out the programme of self-rehabilitation and tele-rehabilitation with the AutonHome® device in addition to conventional rehabilitation.
Receives: Device: AutonHome® device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 0 and 6 weeks

Secondary outcomes (19)
  1. Evaluate the recovery of overall functional independence.

    Functional independence measure - MIF

    Independence :

    7: Complete independence (appropriate to circumstances and safe) 6: Modified independence (device, adaptation)

    Modified dependence :

    5: Supervision 4: Minimal assistance (autonomy = 75% +) 3 : Average assistance (autonomy = 50% +)

    Complete dependence 2 : Maximum assistance (autonomy = 25% +)

    If an item cannot be checked, tick level 1.

    At the end of the test, we obtain a score ranging from 18 to 126. The lower the score, the greater the disability.

    Measured: At 0, 6, 12 and 15 weeks

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

    Berg balance scale :

    The Berg balance assessment scale was developed to measure static and dynamic balance in adults.

    This scale comprises 14 tasks rated from 0 to 4, assessing both static and dynamic balance. The total score ranges from 0 to 56 points. The higher the score, the better the assessment of balance.

    Measured: At 0, 6, 12 and 15 weeks

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

    6min walk test (6MWT) : The six-minute walk test (6MWT) is an objective assessment of functional physical ability. It measures the distance covered by the patient when walking briskly for 6 minutes.

    The 6MWT provides a global assessment of various organ functions, in particular the cardiopulmonary, vascular and neuromuscular systems.

    Distance covered: The distance covered during the test is the main parameter measured. In general, a longer distance indicates better functional capacity. Here are some approximate reference values:

    Normal: Approximately 400 to 700 metres. Poor: Less than 300 metres. Very good: Over 800 metres.

    Measured: At 0, 6, 12 and 15 weeks

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

    10-metre walk test (10MWT) : The 10-metre walk test is an assessment tool that measures a patient's walking speed.

    It aims to calculate the speed at which a patient can walk a distance of 10 metres.

    The walking speed obtained can be used to classify the patient into different categories:

    Less than 0.4 m/s: Walking at home. Between 0.4 and 0.8 m/s: Limited walking in the community. More than 0.8 m/s: Unlimited walking in the community.

    Measured: At 0, 6, 12 and 15 weeks

  5. Achievement of objectives

    GAS (Goal Attainment Scaling) :

    The GAS is a tool for defining specific, individualised objectives for each patient. These objectives are then evaluated in a standardised way, allowing statistical analysis of the results.

    At least 3 objectives are set and scored between -3 (regression), -2 (much less), -1 (a little less), 0 (expected result), +1 (a little more), +2 (much more).

    Measured: At 0, 6, 12 and 15 weeks

  6. Autonomy and social participation

    IPA Scale (Impact on Participation and Autonomy Questionnaire) :

    • Level of participation perceived by the participant through 32 items spread over 5 domains related to autonomy in activities inside the home (7 items), family roles (7 items), activities outside (5 items), social life and relationships (7 items), work and education (6 items). The last 6 are excluded. Score from 0 (very low level of participation) to 4 (very high level).
    • Level of perception of participation restriction: Score of 0 (major problem), 1 (minor problem), 2 (no problem).

    Measured: At 0, 6, 12 and 15 weeks

  7. The risk of adverse effects

    Number of falls

    Measured: Every day during 15 weeks

  8. The risk of adverse effects

    Number of moderate or serious adverse events during the session

    Measured: Every day during 15 weeks

  9. The risk of adverse effects

    Visual Analog Pain Scale: Intensity and sites of pain before or during and after the session

    Measured: Every day during 15 weeks

  10. The perception of the effort at each session

    Borg scale :

    The Borg scale is generally rated from 6 to 20. The higher the number, the more intense the perceived effort.

    Measured: Every day during 15 weeks

  11. The perceived experience of the session.

    Perceived experience of the rehabilitation session in response to the following 4 questions with a scoring that comes in 5 different levels depending on the question :

    What is the patient's perception of the rehabilitation session offered? Very poor - Poor - No effect - Positive - Very positive

    What is the patient's perception of the quality of the exercises proposed? Very poor - Poor - No effect - Positive - Very positive

    What is the patient's perception of the intensity of the exercises proposed? Very poor - Poor - No effect - Positive - Very positive

    What is the patient's perception of the motivating nature of the exercises proposed? Very poor - Poor - No effect - Positive - Very positive

    Measured: Every day during 15 weeks

  12. The perceived experience of the session.

    SIMS MOTIVATION Scale ("Situation Motivation Scale") :

    The aim is to determine which type of motivation regulates an individual's behaviour during an activity.

    16 items are evaluated: Items 1, 5, 9 and 13 relate to intrinsic motivation (best type of regulation, strong feeling of autonomy).

    Items 2, 6, 10 and 14 relate to identified regulation (good type of regulation, high sense of autonomy).

    Items 3, 7, 11 and 15 refer to external regulation (poor type of regulation, low sense of autonomy).

    Items 4, 8, 12 and 16 relate to motivation (no regulation).

    Measured: Every day during 15 weeks

  13. Compliance with and duration of sessions and stays.

    Compliance (present at the session) : Yes/No

    Measured: Every day during 15 weeks

  14. Compliance with and duration of sessions and stays.

    Duration of each session (in minutes)

    Measured: Every day during 15 weeks

  15. Compliance with and duration of sessions and stays.

    Duration of stay in complete hospitalisation (in days)

    Measured: Every day during 15 weeks

  16. Compliance with and duration of sessions and stays.

    Duration of stay in partiel hospitalisation (in days)

    Measured: Every day during 15 weeks

  17. Compliance with and duration of sessions and stays.

    Duration of use at home (in days)

    Measured: Every day during 15 weeks

  18. Study the medium-term appropriation of the selfrehabilitation system by the participants.

    SUS (System Usability Scale) : only for the experimental groups. The SUS consists of 10 questions in the form of statements. Each question uses a Likert scale, where the user chooses between 5 possible answers, ranging from 'Strongly disagree' to 'Strongly agree'. The answers to the 10 questions are used to construct a satisfaction score, ranging from 1 to 100. In general, a score of 75 or more is considered 'good', while between 50 and 75 it is considered 'fair' or 'correct'. A score of less than 50 indicates major problems in terms of customer satisfaction.

    Measured: At 0, 6, 12 and 15 weeks

  19. Compare the costs of the experimental care pathway to the costs of a conventional care pathway

    Study of direct and indirect costs

    Measured: Every day during 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study start6 May 2024
  3. Primary completionOct 2025 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06443840
Sponsor's protocol ID
2023-A01298-37
Acronym
AUTONHOME
Status last verified
May 2024
First submitted
14 May 2024
Last updated
5 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing AutonHome® device in people with Hemorrhagic Unilateral Cortico-subcortical Hemispheric Stroke and Ischemic Stroke, run by Association APPROCHE at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marie-Caroline Delebecque, CRA (0297826174 ext. +33, approche@mutualite29-56.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: At 0 and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06443840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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