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临床试验 NCT05657548 (SPS-PC) 针对婴儿脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy (SPS-PC) 100
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临床试验NCT05657548 (SPS-PC)是一项针对婴儿脑瘫的观察研究试验，目前试验状态为招募中。试验始于2023年10月30日，计划招募100名患者。该研究由Centre Hospitalier Universitaire de Nīmes主导，预计于2027年10月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月29日。
简要概括
Cerebral palsy is the leading cause of motor disability in children. Children with little or no walking (GMFCS III, IV and V) represent 43% of children with cerebral palsy, the majority of whom present pelvic and spinal deformities in the frontal and sagittal planes. However, sagittal pelvic spinal statics have been little studied, especially in the sitting position, which is the functional position of these children...显示更多
官方标题
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
疾病
婴儿脑瘫其他研究标识符
- SPS-PC
- Local/2022/CL-01
- ANSM (其他标识符) (2022-A01466-37)
NCT编号
实际开始日期
2023-10-30
最近更新发布
2025-09-29
预计完成日期
2027-10
计划入组人数
100
研究类型
观察研究
试验状态
招募中
关键词
Spine
Child
Adolescent
Pelvis
Postural Balance
Posture
Radiography
Child
Adolescent
Pelvis
Postural Balance
Posture
Radiography
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Child with Cerebral Palsy Children and adolescents from 4 to 17 years old with cerebral palsy GMFCS III, IV or V followed in the Physical Medicine and Rehabilitation Department, Children's Rehabilitation Unit of the University Hospital of Nîmes (Carémeau Hospital) | spine and pelvis radiography X-ray of the spine and pelvis from the front and the side will be performed under the standardized conditions that we put in place: in a sitting position on a specific modular chair. |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Evolution of the sagittal spinal statics in the sitting position | measurement of pelvic incidence (normal values between 35 and 85 degrees) | At baseline |
Evolution of the sagittal spinal statics in the sitting position | sacral slope (angle of inclination of the sacral plateau in profile to the horizontal (degrees)) | At baseline |
Evolution of the sagittal spinal statics in the sitting position | pelvic version (angle between the vertical and the line joining the center of the femoral heads with the middle of the sacral plateau (in degrees)) | At baseline |
Evolution of the sagittal spinal statics in the sitting position | lordoses cervicales (in degrees) | At baseline |
Evolution of the sagittal spinal statics in the sitting position | lumbar lordosis (in degrees) | At baseline |
Evolution of the sagittal spinal statics in the sitting position | thoracic kyphosis (in degrees) | At baseline |
Evolution of the sagittal spinal statics in the sitting position | Cobb angle (if scoliosis) (curvature greater than 10 degrees : definition of scoliosis; between 10 and 15 degree: benign scoliosis; between 15 and 35 degrees: moderate scoliosis; curvature greater than 35 degrees: significant scoliosis.) | At baseline |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
4 Years
适龄性别
全部
- Child or adolescent aged 4 to 17 years
- Child or adolescent with cerebral palsy GMFCS III, IV or V
- Child or adolescent whose parents, or the child if possible, have given free, informed and written consent
- Child or adolescent affiliated or beneficiary of a health insurance plan
- Child or adolescent with history of spinal surgery
- Child or adolescent with parents unable to give consent
- Child or adolescent participating in a therapeutic research study (RIPH 1 or drug study)
- Child or adolescent in an exclusion period determined by another study
- Child or adolescent under court protection, guardianship or curatorship
- Pregnant, parturient or breastfeeding patient
Centre Hospitalier Universitaire de Nīmes研究中心联系人
联系人: Mélanie PORTE, +33 4.66.68.34.59, [email protected]
联系人: Cloé LAFFARGUE, +33 4.66.68.34.59, [email protected]
1 位于 1 个国家/地区的研究中心
CHU de Nîmes, Nîmes, 30029, France
Mélanie PORTE, 联系人, +33466683459, [email protected]
Cloé LAFFARGUE, 联系人, +33466683459, [email protected]
招募中