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临床试验/NCT04603625
NCT04603625已完成不适用

Postural Management to Prevent Hip Luxation in Quadriplegic Cerebral Palsy Children: Comparing Two Approaches in a Randomized Controlled Trial

Azienda USL Reggio Emilia - IRCCS1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2020年10月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
1
主要终点
Change in Migration Percentage

研究概览

简要总结

Cerebral palsy (CP) is the most common motor disability in childhood. Among these, hip luxation represents the most frequent and clinically relevant one, affecting 72% of non-ambulatory CP children. Reconstructive surgical treatment is debated in severe CP children, for whom it is crucial to identify an effective preventive approach. The aim of our study is to verify if keeping a sitting position centering femoral heads is more effective than usual postural management (sitting with the trunk aligned and hips abducted), in preventing hip luxation in quadriplegic CP children. It's a multicenter randomized controlled study (13 sites involved). A total of 102 quadriplegic CP children, aged 1-6 years-old, classified as Gross Motor Function Measure System 4 or 5, will be recruited and randomized to usual or experimental sitting, at least 5 hours a day, for 2 years. The primary outcome will be the degree of luxation, measured by means of the Migration Percentage (MP), on pelvic radiography, at 12 and 24 months. Secondary outcomes will include compliance and Health Related-Quality of Life, using validated tools, hip pain, device cost, MRI lesions, concurrent direct neuromotor treatment, use of standing devices and spasticity treatments (botulinum toxin, per os or intrathecal baclofen, selective dorsal rhizotomy). Experimental sitting is expected to reduce the MP change compared to usual care. It will be of interest to compare compliance, QoL and costs in either groups: aspects affecting the effectiveness. Furthermore to evaluate correlations between MP and spasticity treatments, MRI lesion type, and other clinical features.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Physicians measuring Migration Percentage (Primary Outcome) will be blind

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Cerebral palsy spastic or dyskinetic
  • GMFCS 4 or 5
  • Informed Consent acquired

排除标准

  • muscle contracture overcoming defined passive Range Of Motion (ROM)limits
  • anterior hip luxation
  • previous reconstructive hip surgery
  • preventive surgery in previous 12 months
  • lumbar scoliosis >20° Cobb

研究组 & 干预措施

sitting position centering femoral heads

Experimental

sitting position centering femoral heads according to Lespargot diagram

干预措施: postural management (Other)

Usual postural management

Active Comparator

sitting with the trunk aligned and hips abducted to facilitate activities of daily living

干预措施: postural management (Other)

结局指标

主要结局

Change in Migration Percentage

时间窗: Day 0, Month 12, Months 24

measure of hip luxation on pelvic radiography

次要结局

  • Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)(Day 0, Month 12, Month 24)
  • Assistive devices costs(Day 0, Month 6, Month 12, Month 18, Month 24)
  • Percentage of patients attending Botulinum Toxin-A injections(Day 0, Month 6, Month 12, Month 18, Month 24)
  • Age(Day 0)
  • Sex(Day 0)
  • Incidence of pain(Day 0, Month 6, Month 12, Month 18, Month 24)
  • Type of CP (Dyskinetic or spastic)(Day 0)
  • Percentage of patients taking Baclofen per os(Day 0, Month 6, Month 12, Month 18, Month 24)
  • Percentage of patients who underwent Selective Dorsal Rhizotomy (SDR)(Day 0)
  • Percentage of patients having Intrathecal Baclofen (ITB)(Day 0)
  • Quebec User Evaluation of Satisfaction with Assistive Technology (IT-QUEST)(Month 12, Month 24)
  • Percentage of patients attending direct physical treatment(Day 0, Month 6, Month 12, Month 18, Month 24)
  • Percentage of patients using standing devices in abduction(Day 0, Month 6, Month 12, Month 18, Month 24)
  • Type of lesion at MRI(Day 0)

研究者

发起方
Azienda USL Reggio Emilia - IRCCS
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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