2024-518822-33-01招募中4 期
Intrathecal baclofen pump versus selective dorsal rhizotomy for non-ambulatory children with cerebral palsy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in CP-CHILD caregiver version (in absolute value) in the first year postoperatively vs. immediately preoperatively (non-inferiority margin = clinically meaningful difference = 5/100).
研究概览
简要总结
To compare the health-related quality of life, safety profile and cost effectiveness and cost utility 1 year after SDR and ITB in non-ambulatory children with spastic Cerebral palsy.
研究设计
- 分配方式
- Randomized
- 主要目的
- Intervention and Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants eligible for inclusion in this Trial must meet all of the following criteria:
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. Informed assent has been obtained by the child in a manner that is appropriate for their age and understanding.
- •Male or female patients
- •Aged ≥ 4 and <18 years
- •With spastic CP
- •Gross motor function classification system (GFMCS) grade 4 or 5
- •Spasticity insufficiently controlled with conservative therapy and/or oral baclofen or intolerable side effects. Patients are allowed to continue or change their usual medication during the study. We will register concomitant medication throughout the study so we can evaluate whether this can be reduced over time. Cross-over neurosurgical procedures (ITB after SDR, or SDR after ITB) are not allowed during the first year in order to not influence the impact of our techniques. Orthopedic interventions and/or botulinum to
排除标准
- •Participants eligible for this Trial must not meet any of the following criteria:
- •Basal ganglia/thalamus lesions or normal brain MRI
- •<15kg body weight
- •Previous ITB/SDR surgery
- •Evidence of genetic illness
- •Evidence of neurological progressive illness
结局指标
主要结局
Change in CP-CHILD caregiver version (in absolute value) in the first year postoperatively vs. immediately preoperatively (non-inferiority margin = clinically meaningful difference = 5/100).
Change in CP-CHILD caregiver version (in absolute value) in the first year postoperatively vs. immediately preoperatively (non-inferiority margin = clinically meaningful difference = 5/100).
次要结局
- Key secondary endpoints: Adverse events; cost-effectiveness and cost-utility. Additional secondary endpoints: Spasticity; range of motion; trunk control; communication; orobulbar function; sleep; urinary symptoms; spinal/hip deformities; medication use; quality of life; treatment goals; parental distress; patient satisfaction; healthcare costs; complications.
研究者
Philippe De Vloo
Scientific
UZ Leuven
研究点 (2)
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