Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients
COVIRSCOL
1 other identifier
interventional
74
1 country
1
Brief Summary
Scoliosis is a progressive three-dimensional deformation of the spine during growth, with a prevalence of 80% in girls. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedStudy Start
First participant enrolled
October 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedMarch 18, 2020
March 1, 2020
3.5 years
May 15, 2019
March 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medio-lateral displacement during lateral inclination of scoliosis patients in the group with rehabilitation enriched by the virtual brace (group G1) compared with the reference treatment (group G0) at D180.
Difference between D180 and D0 of the medio-lateral displacement of the pressure center during the lateral inclination in both groups G0 and G1. This parameter is evaluated during the conventional 3D motion capture analysis.
6 months
Secondary Outcomes (7)
Quantification of kinematic, postural and electromyographic anomalies during trunk tilting and rotation (for both groups G0 and G1).
6 months
Quantification of the quality of life evaluated with the Scoliosis Research Society Patient questionnaire (SRS-22), for both groups G0 and G1.
6 months
Quantification of kinematic feedback provided by the virtual-brace and their deviation from the prescription (only for group G1)
6 months
Treatment compliance for the rigid-brace (for both group G1 and G0)
6 months
Treatment compliance for the virtual-brace (only for group G1)
6 months
- +2 more secondary outcomes
Study Arms (2)
Night-time brace + virtual-brace
EXPERIMENTALPatients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD).
Night-time brace only
ACTIVE COMPARATORPatients are conventionally treated with night-time brace only.
Interventions
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.
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
You may qualify if:
- Patients with idiopathic scoliosis (left lumbar or right thoracic),
- 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
You may not qualify if:
- Patients with an unstabilized medical problem,
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Grenoble
Grenoble, 38043, France
Study Officials
- PRINCIPAL INVESTIGATOR
Aurelien COURVOISIER, MD, PhD
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2019
First Posted
June 7, 2019
Study Start
October 11, 2019
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
March 18, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share