试验雷达 AI | ||
|---|---|---|
临床试验 NCT06991725 (Bo-Balance) 针对Spastic Cerebral Palsy (sCP)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。 | ||
一个试验符合筛选条件
卡片视图
Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscular Harm (Bo-Balance) 51
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT06991725 (Bo-Balance)是一项针对Spastic Cerebral Palsy (sCP)的观察研究试验，目前试验状态为招募中。试验始于2025年2月3日，计划招募51名患者。该研究由Universitaire Ziekenhuizen KU Leuven主导，预计于2028年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月10日。
简要概括
A cross-sectional design study will be carried out to explore the morphological muscle properties and alterations in muscle composition on a macroscopic level in children with spastic cerebral palsy (CP). Muscle composition will be assessed using quantitative Magnetic Resonance Imaging (qMRI) and shear wave elastography (SWE), while macroscopic muscle size properties will be evaluated through 'Three-dimensional freeh...显示更多
详细描述
Background: Altered muscle composition, including increased fat infiltration and collagen content, is a key factor in impaired muscle function in cerebral palsy (CP). However, quantitative data on muscle composition in CP is limited. Traditional methods like ultrasound can only indirectly assess these changes through echo-intensity, while invasive muscle biopsies are impractical for children. Recent advancements in q...显示更多
官方标题
Botulinum Neurotoxin for Children With Cerebral Palsy: a Delicate Balance Between Clinical Benefits and Muscular Harm
疾病
Spastic Cerebral Palsy (sCP)其他研究标识符
- Bo-Balance
- S62187_Bo-Balance
NCT编号
实际开始日期
2025-02-03
最近更新发布
2026-02-10
预计完成日期
2028-12
计划入组人数
51
研究类型
观察研究
试验状态
招募中
关键词
Spastic Cerebral Palsy
Muscle composition
3D freehand ultrasound
Shear wave elastography
Muscle morphology
Range of motion
Stiffness
Spasticity
Muscle composition
3D freehand ultrasound
Shear wave elastography
Muscle morphology
Range of motion
Stiffness
Spasticity
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Children with spastic cerebral palsy Children between 2 years and 16 years old | 不适用 |
Typically developing children Children between 2 years and 16 years old | 不适用 |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Evaluation of the muscle volume of the medial gastrocnemius muscle | Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth. | Cross-sectional data collection at day 1. |
Evaluation of the muscle length of the medial gastrocnemius muscle | Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth | Cross-sectional data collection at day 1. |
Evaluation of the muscle echo-intensity of the medial gastrocnemius muscle | Estimation of the echo-intensity by 3DfUS. | Cross-sectional data collection at day 1. |
Evaluation of the fat fraction of the medial gastrocnemius muscle. | Estimation of the fat fraction by Dixon sequence (MRI): a comparison of muscle fat fraction between children with CP and healthy age-matched TD controls in different age groups. | Cross-sectional data collection at day 1. |
Indirect evaluation of collagen content of the medial gastrocnemius muscle | Indirect estimation of collagen content by T1ƿ relaxation time (MRI): a comparison between children with CP and healthy age-matched TD controls in different age groups. | Cross-sectional data collection at day 1. |
Evaluation of passive muscle stiffness across the medial gastrocnemius muscle. | Estimation of the passive muscle stiffness by shear modulus (SWE): a comparison of passive muscle stiffness between children with CP and healthy age-matched TD controls in different age groups. | Cross-sectional data collection at day 1. |
Evaluation of differences in fat fraction in different regions across the medial gastrocnemius muscle. | Comparison of differences in fat fraction across three regions (proximal, midbelly, distal) of the muscle belly in children with CP compared to TD children. | Cross-sectional data collection at day 1. |
Evaluation of differences in passive muscle stiffness in different regions across the medial gastrocnemius muscle. | Comparison of differences in passive muscle stiffness across three regions (midbelly, distal, upper fascia of midbelly) of the muscle belly in children with CP compared to TD children. | Cross-sectional data collection at day 1. |
Evaluation of the muscle strength (ankle torque). | Evaluating the muscle strength (ankle torque) using the handheld dynamometer. | Cross-sectional data collection at day 1. |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
2 Years
适龄性别
全部
接受健康志愿者
是
- Children (boys/girls) with congenital brain lesion, confirmed with neuro-imaging such as MRI
- At high-risk for CP or diagnosed spastic type of CP
- (Suspected) Gross Motor Function Classification Scale (GMFCS) Level I-III
- Uni or bilateral involvement
- Aged between 2-16 years
Presence of dyskinesia or ataxia
Severe co-morbidities (cognitive problems)
BTX treatment in past 10 months
Previous surgery less than 12 months at the investigated muscles.
Previous orthopedic or neurosurgery
Severe ankle deformities
Weight for height values >2SD from mean
- Typically developing children
Inclusion criteria:
• Aged between 2-16 years
Exclusion criteria:
- History of neurological, orthopedic or muscular problems
- Involvement in an elite or high-performance sporting program (Children performing the same sports for > 5 hours/week will be excluded)
Universitaire Ziekenhuizen KU Leuven研究责任方
Kaat Desloovere, 主要研究者, Prof. dr., Universitaire Ziekenhuizen KU Leuven
研究中心联系人
联系人: Charlotte Lambrechts, +32489421264, [email protected]
联系人: Julie Stegen, +32477273954, [email protected]
1 位于 1 个国家/地区的研究中心
Vlaams-Brabant
UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium
Kaat Desloovere, prof. dr., 联系人, +3216338009, [email protected]
招募中