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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Idiopathic Scoliosis | Device: Night-time brace + virtual-brace Other: Night-time brace only | Not Applicable |
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).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 74 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients: A Prospective, Monocentric, Randomized With Stratification on the Type of Scoliosis, Comparative and Open-label Study |
| Actual Study Start Date : | October 11, 2019 |
| Estimated Primary Completion Date : | April 2023 |
| Estimated Study Completion Date : | April 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Night-time brace + virtual-brace
Patients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD).
|
Device: Night-time brace + virtual-brace
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. |
|
Active Comparator: Night-time brace only
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. Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180. |
| Ages Eligible for Study: | 9 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Aurelien COURVOISIER, MD, PhD | 476767313 ext 0033 | Echipon@chu-grenoble.fr | |
| Contact: Emilie CHIPON, PhD | 476767313 ext 0033 | Echipon@chu-grenoble.fr |
| France | |
| University Hospital Grenoble | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Aurelien COURVOISIER, MD, PhD Echipon@chu-grenoble.fr | |
| Sub-Investigator: Jacques GRIFFET, MD, PhD | |
| Sub-Investigator: Veronique BOURG-ROSTAING, MD | |
| Principal Investigator: | Aurelien COURVOISIER, MD, PhD | University Hospital, Grenoble |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 15, 2019 | ||||||||
| First Posted Date ICMJE | June 7, 2019 | ||||||||
| Last Update Posted Date | March 18, 2020 | ||||||||
| Actual Study Start Date ICMJE | October 11, 2019 | ||||||||
| Estimated Primary Completion Date | April 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. [ Time Frame: 6 months ] 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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients | ||||||||
| Official Title ICMJE | Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients: A Prospective, Monocentric, Randomized With Stratification on the Type of Scoliosis, Comparative and Open-label Study | ||||||||
| 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. |
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| Detailed Description |
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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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Idiopathic Scoliosis | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
74 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 2023 | ||||||||
| Estimated Primary Completion Date | April 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 9 Years to 16 Years (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03978273 | ||||||||
| Other Study ID Numbers ICMJE | 38RC18.053 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University Hospital, Grenoble | ||||||||
| Study Sponsor ICMJE | University Hospital, Grenoble | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University Hospital, Grenoble | ||||||||
| Verification Date | March 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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