ACTRN12617000006347招募中未知
Harnessing Neuroplasticity to Improve Motor Performance in Infants with Cerebral Palsy: a Pragmatic Randomized Controlled Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 3 Months 至 6 Months(—)
- 性别
- All
入选标准
- •(a) Aged 3-6.5 months corrected for prematurity;
- •(b) Discharged home from hospital; and
- •(c) Diagnosis of cerebral palsy OR (d) diagnosis of high risk of cerebral palsy” via: (i) General Movements Absent fidgety” score + abnormal brain MRI/CUS indicating cerebral palsy; OR (ii) General Movements Absent fidgety” score + Hammersmith Infant Neurological Examination score <57@ 3 months / <59 6 months; OR (iii) Abnormal brain MRI/CUS indicating cerebral palsy + Hammersmith Infant Neurological Examination score <57@ 3 months / <59@ 6 months of age.; OR (iv) imaging evidence of a unilateral brain injury on MRI/CUS + clinical signs of asymmetry + Hammersmith Infant Neurological Examination score in optimal range
排除标准
- •(a) Drug resistant epilepsy meeting the International League Against Epilepsy (ILAE) criteria;
- •(b) Severe vision impairment (unable to fix and follow in good light);
- •(c) medically fragile preventing safe child-active participation in training; and
- •(d) living in remote location inaccessible by study personnel for home visits.
研究者
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