Last modified: 2018-09-09
Abstract
Introduction
Perinatal stroke affects around 1/3500 infants and frequently leads to unilateral cerebral palsy. Early intervention could improve motor outcomes. Aim: to test feasibility and acceptability of an Early Therapy in Perinatal Stroke intervention (eTIPS).
Patients and Methods
This feasibility trial (ISRCTN12547427) took place in North-East England, UK, August 2015-September 2017. Participants: infants with unilateral perinatal stroke (PS) or haemorrhagic parenchymal infarction (HPI) and their parents and therapists. Intervention: a parent-delivered lateralised therapy approach in the first 6 months of life. Outcome measures: feasibility (recruitment and retention rates for PS infants); acceptability (parental questionnaires, qualitative observations and in-depth interviews with parents and therapists). We also reviewed clinical imaging data, undertook clinical, research and exploratory assessments of motor function, and a questionnaire assessment of parental mental wellbeing.
Results
Within 18 months we screened 20 infants referred as PS/HPI: of these, 14 met the inclusion criteria and 13 undertook the study. One additional patient declined to attend a screening appointment. At 6 months, 11 (85%) of those enrolled had completed the final assessment. Parents and therapists valued the intervention, finding it to be acceptable and workable. The Hand Assessment for Infants was well tolerated by infants and highly valued by parents. Completion rates for the Warwick-Edinburgh Mental Wellbeing Scale were high and did not suggest adverse effects on parental mental wellbeing. There were no adverse events related to the intervention.
Conclusion
ETIPS was feasible to deliver and acceptable. We plan to investigate efficacy in a multicentre randomised controlled trial.