The Integration of Macroscopic and Microscopic Muscle Properties With Cell Modelling to Feature Altered Neuromuscular Behavior in Cerebral Palsy: 3D-Macroscopic Muscle Architecture in Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Overall change in muscle length of the medial gastrocnemius muscle and the semitendinosus muscle.
研究概览
简要总结
A mixed longitudinal design study will be carried out to explore the onset and time course of morphological muscle changes on a macroscopic level in children with spastic cerebral palsy (SCP). Therefore, this project aims to (1) describe the macroscopic morphological muscle changes with increasing age and (2) evaluate the onset and development of muscle alterations in relation to the brain lesion (e.g., timing, extent and location), to the neuromuscular impairments and to treatment. Overall, this project will evaluate the macroscopic muscle properties by means of 3D freehand ultrasound (3DfUS).
详细描述
Background:
Recent literature reviews have emphasized the need for longitudinal studies with multiple measurement time- points to properly identify the natural course of muscle growth in young children with SCP, compared to typically developing (TD) children. The etiology of SCP, including the underlying brain lesion, may also be relevant to understand the onset and early development of altered muscle growth. Since the perinatal brain lesion in congenital SCP results in early abnormal neuronal input to the muscle, the process of muscle formation and maturation is likely to be disturbed. Because the overall treatment goal is to improve and maintain the functional abilities of children with SCP, there is a growing interest in the relation between the brain lesions (defined by MRI) and motor outcomes. However, no studies have systematically explored the relation between intrinsic muscle alterations and the brain lesion characteristics.
Improved understanding of morphologically muscle changes during growth, and how the participants relate to the timing of the brain lesion, to clinical neuromuscular impairments and to treatment, has potential to classify SCP muscles into sub-groups, or phenotypes. Moreover, these insights can reveal new markers to optimize treatment protocols or develop new treatments, leading to patient-tailored treatment management and new avenues for improving function in children with SCP.
Aim:
The focus of this study is to improve insights in the onset, development and progression of morphological macroscopic muscle changes for growing children with spastic cerebral palsy. The diversity in macroscopic muscle growth will thereby be considered in longitudinal studies, starting shortly after the occurrence of the brain injury.
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
- 6 Months 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of spastic cerebral palsy or patients at high-risk for spastic cerebral palsy
- •Suspected GMFCS levels I-III (GMFCS = Gross Motor Function Classification Scale, expressing the overall functional level of impairment)
排除标准
- •Non-ambulatory
- •Botulinum neurotoxin type-A injections six months prior to enrollment
- •Lower limb surgery two years prior to enrollment
- •Muscle surgery at the muscles in the lower limb
- •Selective dorsal rhizotomy as treatment history
- •Presence of ataxia or dystonia
- •Severe co-morbidities (severe epilepsy, severe behavior problems that impede the cooperation)
研究组 & 干预措施
Children with spastic cerebral palsy
Children between 6 months and 9 years old.
Typically developing children
Children between 6 months and 9 years old.
Children with an acquired brain injury
Children between 1,5 years and 9 years.
结局指标
主要结局
Overall change in muscle length of the medial gastrocnemius muscle and the semitendinosus muscle.
时间窗: Through a study participation of 2 years, with an evaluation moment every 6 months.
Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth.
Overall change in muscle volume of the medial gastrocnemius muscle and the semitendinosus muscle
时间窗: Through a study participation of 2 years, with an evaluation moment every 6 months.
Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth.
Evaluation of the brain lesion based on MRI imaging
时间窗: Once during the study participation of 2 years.
Estimation of the type, extend and location of the brain lesion by MRI imaging assessment tool (Fiori scale)
Overall change in muscle echo-intensity of the medial gastrocnemius muscle and the semitendinosus muscle.
时间窗: Through a study participation of 2 years, with an evaluation moment every 6 months.
Estimation of the echo-intensity by 3DfUS.
次要结局
- Overall change of muscle strength of the medial gastrocnemius muscle and the semitendinosus muscle.(Through a study participation of 2 years, with an evaluation moment every 6 months.)
- Orthotics(Through a study participation of 2 years, with an evaluation moment every 6 months.)
- Overall change in pennation angle of the medial gastrocnemius muscle and the semitendinosus muscle.(Through a study participation of 2 years, with an evaluation moment every 6 months.)
- Overall change of spasticity of the medial gastrocnemius muscle and the semitendinosus muscle.(Through a study participation of 2 years, with an evaluation moment every 6 months.)
- Change in fascicle length of the medial gastrocnemius muscle and the semitendinosus muscle.(Through a study participation of 2 years, with an evaluation moment every 6 months.)
- Overall change of muscle selectivity of the medial gastrocnemius muscle and the semitendinosus muscle.(Through a study participation of 2 years, with an evaluation moment every 6 months.)
- Physiotherapy(Through a study participation of 2 years, with an evaluation moment every 6 months.)
- Overall change of range of motion of the ankle and knee joint(Through a study participation of 2 years, with an evaluation moment every 6 months.)
研究者
Kaat Desloovere
Prof. dr.
Universitaire Ziekenhuizen KU Leuven