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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Night-time brace + virtual-brace
Patients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD).
干预措施: Night-time brace + virtual-brace (Device)
Night-time brace only
Patients are conventionally treated with night-time brace only.
干预措施: Night-time brace only (Other)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
- Quantification of kinematic, postural and electromyographic anomalies during trunk tilting and rotation (for both groups G0 and G1).(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.(6 months)
- Treatment compliance for the virtual-brace (only for group G1)(6 months)
- Quantification of electroencephalogram (EEG) modifications during postural and walk initiation tasks (for both groups G0 and G1).(6 months)