An interventional study of Night-time brace + virtual-brace and Night-time brace only in Idiopathic Scoliosis, sponsored by University Hospital, Grenoble. Status unknown at 1 site in France. Open to participants aged 9 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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.
The present study is the first evaluation of the efficacy of the virtual-brace on scoliotic patients.
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).
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's planned enrollment of 74 is above the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
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Exclusion Criteria:
Patients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD).
Device: Night-time brace + virtual-brace
Patients are conventionally treated with night-time brace only.
Other: Night-time brace only
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.
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.
Time frame: 6 months
Quantification of kinematic, postural and electromyographic anomalies during trunk tilting and rotation (for both groups G0 and G1).
Conventional 3D motion capture analysis with surface ElectroMyoGram (EMG) pattern's at D0, D90 and D180.
Time frame: 6 months
Quantification of the quality of life evaluated with the Scoliosis Research Society Patient questionnaire (SRS-22), for both groups G0 and G1.
Difference in the result of the SRS-22 questionnaire between D180 and D0. SRS-22 is a self-reported questionnaire assessing self-image, function, pain, mental health, and satisfaction with care with score range from 1 to 5 (1=worst and 5= best) for each 22 questions. The global score is the mean score of all questions.
Time frame: 6 months
Quantification of kinematic feedback provided by the virtual-brace and their deviation from the prescription (only for group G1)
Time course of the angular data of the trunk relative to the pelvis provided by the virtual brace, versus the prescribed exercises (evaluated every 3 weeks during the visit to the physiotherapist)
Time frame: 6 months
Treatment compliance for the rigid-brace (for both group G1 and G0)
Compliance with the wearing of the rigid brace reported in the patient follow-up logbook.
Time frame: 6 months
Treatment compliance for the virtual-brace (only for group G1)
Only for group G1 : effective rehabilitation time collected from the virtual brace's log files.
Time frame: 6 months
Quantification of electroencephalogram (EEG) modifications during postural and walk initiation tasks (for both groups G0 and G1).
Conventional 3D motion capture analysis with EEG records at D0, D90 and D180.
Time frame: 6 months
Exploratory Objective : Descriptive analysis by group of all parameters related to postural disorders recorded during Conventional 3D motion capture analysis with EMG, EEG.
Set of variables related to the severity of the postural disorder.
Time frame: 6 months
Plan to share: No
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble