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| Name | Class |
|---|---|
| Clinical Investigation Centre for Innovative Technology Network | NETWORK |
| University Grenoble Alps | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Night-time brace + virtual-brace | Experimental | Patients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD). |
|
| Night-time brace only | Active Comparator | Patients are conventionally treated with night-time brace only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Night-time brace + virtual-brace | Device | Patients will receive conventional treatment : wearing a night-time brace every night during 6 months. Additionally :
Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Quantification of the quality of life evaluated with the Scoliosis Research Society Patient questionnaire (SRS-22), for both groups G0 and G1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurelien COURVOISIER, MD, PhD | Contact | 476767313 | 0033 | Echipon@chu-grenoble.fr |
| Emilie CHIPON, PhD | Contact | 476767313 | 0033 | Echipon@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Aurelien COURVOISIER, MD, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | Recruiting | Grenoble | 38043 | France |
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| Night-time brace only | Other | 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. |
|
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. |
| 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) | 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. | 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. | 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. | 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. | 6 months |