Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Change of hip migration (%) and/or scoliosis (Cobb angle) during the 10 years of patients' follow-up.
研究概览
简要总结
" Cohort CP " is a multicentre cohort study, initiated by the Hospices Civils de Lyon in September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the rhythm of 1 visit per year. At each visit are collected clinical, orthopaedic, radiological and environmental data.
The primary objective is to establish the incidence of orthopaedic complications (scoliosis and hip joint) depending on patients' age.
Secondary objectives are to describe the sequences over time of these complications and the related pain, to explore the impact of nutrition, surgery, asymmetric postures and environmental factors, and to describe the medical and rehabilitative follow-up of these patients.
385 patients are expected by the end of 2020. We expect of this long-term follow-up to gain tools that permit to improve patient's care and patient's quality of life, by putting in place preventing actions and adapted treatments related to their own pathologies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged from 2 to 10 years at inclusion,
- •with bilateral cerebral palsy,
- •Grade IV or V of the GMFCS.
- •Affiliated with the French healthcare system.
- •Oral consent of the parents obtained.
排除标准
- •Progressive pathology.
结局指标
主要结局
Change of hip migration (%) and/or scoliosis (Cobb angle) during the 10 years of patients' follow-up.
时间窗: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Hip migration is measured in percentage (Rimers method), and scoliosis is measured in degrees (Cobb angle). For the first visit (A00= inclusion), if hip migration measured on the last radiography is ≥ 20%, it is asked to trace the history of the migration with measurements of previous patient's radiographies. For this first visit, if the Cobb angle on the last radiography is ≥ 20°, it is also asked to trace history of scoliosis with previous radiographies. For the following visits (A01 to A10), only the last radiography is required for each year.
次要结局
- Relationship between neurological asymmetry and windswept and/or hip joint.(Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10)
- Description of the rehabilitative and medical follow-up in the studied population.(Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10)
- Impact of nutrition on the occurrence of orthopedic complications and related pain.(Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10)
- Impact of surgical treatment of hip luxation on pain.(Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10)
- Impact of asymmetric postures on the occurrence of orthopedic complications and related pain.(Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10)
- Relationship between environmental factors and orthopedic complications, pain, and nutrition.(Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10)
- Description of the sequences over time of orthopedic complications and the related pain.(Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10)