Topic: Children, Reproductive health and childbirth
Conditions
Interventions
Interventions for infants with stroke: A manualised home-based parent delivered therapy approach with therapist oversight. Additional information and tips for the approach including videos are provide
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current Primary Outcome Measure (as of 10/01/2018) Feasibility and acceptability of approach determined monthly throughout the intervention period, including at a qualitative interview of therapists working with the infants, with parental consent, towards the end of the infant's involvement in the eTIPS intervention. Previous Primary Outcome Measure Feasibility and acceptability of approach determined monthly throughout the intervention period, including at a qualitative interview at 5 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rates of eligibility, consent, participation and retention throughout the study. 2. Infant motor development is measured using the Alberta Infant Motor Scale at baseline, 2, 4 and 6 months, Prechtl’s General Movement Assessments at baseline, 1, 2 and 3 months, the Hand Assessment for Infants at 3, 4, 5 and 6 months, and the Pediatric Stroke Outcome Measure at baseline, 3 and 6 months (the latter for infants with perinatal stroke only) 3. Parental well-being and sense of competence are measured using the Warwick-Edinburgh Mental Wellbeing scale and the Parenting Sense of Competence scale respectively at 1 month and 6 months 4. Exploratory outcomes are measured using Accelerometry at each visit (infant limb movements) and the eTIPS feasibility questionnaire (perinatal stroke group only) at 1 month and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed