Early intervention to improve motor outcome after perinatal stroke: eTIPS pilot feasibility study

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 48 人开始时间: 2015年9月30日最近更新: 2021年10月4日

试验速览

•1. Infants who sustained a predominantly unilateral stroke (arterial ischaemic, haemorrhagic or haemorrhagic periventricular venous infarction) demonstrated on cranial imaging and identified within the first 3 months of life
•2. Aged matched health infants (control group)
•3. Fully informed parental consent and parent/carer with the ability and willingness to adhere to protocol

•Current Participant Exclusion Criteria (as of 10/01/2018)
•1. Additional significant medical diagnoses which would render the therapy inappropriate or outcomes uninterpretable in relation to the therapy (e.g. known progressive or neurodegenerative disorder; severe visual impairment)
•2. Evidence of significant bilateral intracerebral pathology
•3. Strokes shown radiologically to affect only occipital, prefrontal or temporal areas of the brain (which would not be expected to produce adverse motor outcomes)
•4. Ongoing involvement in another research study where this is likely to interfere with the interpretation of either study
•Previous Participant Exclusion Criteria
•1. Extreme prematurity, of less than 26 weeks gestation
•2. Additional significant medical diagnoses which would render the therapy inappropriate or outcomes uninterpretable in relation to the therapy (e.g. known progressive or neurodegenerative disorder; severe visual impairment)
•3. Evidence of significant bilateral intracerebral pathology
•4. Strokes shown radiologically to affect only occipital, prefrontal or temporal areas of the brain (which would not be expected to produce adverse motor outcomes)
•5. Ongoing involvement in another research study where this is likely to interfere with the interpretation of either study

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust