Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients
NCT ID: NCT03978273
Last Updated: 2020-03-18
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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UNKNOWN
NA
74 participants
INTERVENTIONAL
2019-10-11
2023-04-30
Brief Summary
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The treatments currently used are surgery and rigid brace, which aim to stabilize scoliosis evolution. The place of rehabilitation is disputed because the methods are multiple, non-standardized and the sessions are infrequent.
In a previous study (MOUVSCO, NTC02134704), researchers have identified systematic postural abnormalities in patients with scoliosis, and developped a virtual-brace (medical device, MD) to allow real-time self-correction of the trunk position.
The aim of the present study is to evaluate for the first time the efficacy of the virtual-brace on the correction of the posture of scoliotic patients.
The hypothesis is that intensified rehabilitation with the virtual-brace will improve pathological postures related to scoliosis.
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Detailed Description
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The efficacy of rehabilitation will be estimate on the correction of the posture of scoliosis patients over 6 months by comparing 2 groups: a control group of patients conventionally treated with a night-time brace (G0 group\_conventional) and an experimental group of patients wearing a night-time brace, doing postural rehabilitation exercises with the virtual brace and follow-up visits with a physiotherapist (G1 group\_virtual-brace).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Night-time brace + virtual-brace
Patients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD).
Night-time brace + virtual-brace
Patients will receive conventional treatment : wearing a night-time brace every night during 6 months.
Additionally :
* They will perform 5 sessions of postural rehabilitation exercises per week (each of 30 minutes) with the virtual-brace (MD).
* They will have also follow up consultations with a physiotherapist every 21 days, to evaluate treatment observance and to adapt postural exercises according to the results and difficulties encountered.
Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180.
Night-time brace only
Patients are conventionally treated with night-time brace only.
Night-time brace only
Patients will receive conventional treatment : wearing a night-time brace every night during 6 months.
Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180.
Interventions
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Night-time brace + virtual-brace
Patients will receive conventional treatment : wearing a night-time brace every night during 6 months.
Additionally :
* They will perform 5 sessions of postural rehabilitation exercises per week (each of 30 minutes) with the virtual-brace (MD).
* They will have also follow up consultations with a physiotherapist every 21 days, to evaluate treatment observance and to adapt postural exercises according to the results and difficulties encountered.
Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180.
Night-time brace only
Patients will receive conventional treatment : wearing a night-time brace every night during 6 months.
Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180.
Eligibility Criteria
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Inclusion Criteria
* Patients with moderate scoliosis: Cobb angle assessed on the last radiography between 20 ° and 35 °,
* Patients requiring the wearing of a rigid night-time brace,
* Patients having a home computer,
* Patients affiliated to social security or similarly regime,
* Patients who gave their consent to participate in the study,
* Patients whose 2 parents have signed the informed consent
Exclusion Criteria
* Patients with known allergy to elastane,
* Patients with sensitivity to dizziness,
* Patients with pacemaker,
* Patients with implanted cardiac defibrillator,
* Patients with cochlear implant,
* Patients carrying a non-removable metal element,
* Protected patient concerned by articles L1121-5 and L1121-6 of the Public Health Code,
* Patients whose parents are protected by article L1121-8 of the Public Health Code
9 Years
16 Years
ALL
No
Sponsors
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Clinical Investigation Centre for Innovative Technology Network
NETWORK
University Grenoble Alps
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Aurelien COURVOISIER, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital Grenoble
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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38RC18.053
Identifier Type: -
Identifier Source: org_study_id
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