Early intervention in perinatal stroke
Research type
Research Study
Full title
Early intervention to improve motor outcome after perinatal stroke: eTIPS pilot feasibility study
IRAS ID
139709
Contact name
Anna Basu
Contact email
Sponsor organisation
Newcastle Upon Tyne NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of research:
Hemiplegic cerebral palsy (weakness and stiffness of one side of the body due to damage sustained to the developing brain) affects around 12000 children in the UK. The main cause is perinatal stroke (a stroke occurring around or before the time of birth), affecting up to 1 in 2500 live births. During the first six months of life, there is refinement of the descending pathways from the brain to the spinal cord. This refinement is based on the activity levels of the projections, with more active “crossed” projections (going from one side of the brain to the other side of the spinal cord) being retained and uncrossed projections being withdrawn. The damage caused by stroke also alters the ongoing developmental pattern and leads to reduced movement control of the affected side of the body.No standard early therapy exists for infants with perinatal stroke. This study is to address the feasibility of using a therapy intervention, from birth or from diagnosis to six months, in babies who have suffered a perinatal stroke. It will involve a non-invasive, parent-led, home based intervention, aiming to improve movement outcomes.
This study will be open to families of infants in the Northern Region who have had a perinatal stroke affecting one side of the brain. The families will be given materials explaining aspects of the therapy, as well as supervision and support. Home-based assessments will be undertaken monthly from recruitment to six months of age. These will include videoed assessments of movement and also measurements of arm and leg movements using lightweight movement detectors. We will ask families to take part in interviews to give us detailed feedback about their experiences with the study. Typically developing infants who have not suffered a stroke will also be recruited for monthly movement assessments for comparison.
Lay summary of study results:
This research trial took place in the North East of England between August 2015 and September 2017. We undertook the trial to answer questions about a new parent-delivered therapy for babies under 6 months old. This included babies who had a stroke before or around the time of birth; we call these perinatal strokes. Babies who have had a perinatal stroke are at risk of
developing hemiplegic cerebral palsy. We included preterm babies who had a large ("grade IV") bleed into the ventricles of the brain on one side, which can also lead to hemiplegic cerebral palsy. Hemiplegic cerebral palsy is a condition in which there is weakness and stiffness on one side of the body, due to injury to the developing brain. Currently there is no standardised early therapy treatment for babies with
perinatal stroke. The first six months of life is a time when the brain and nerves controlling movement are still intensively developing. Our hope is that by starting therapy very early, the effect of the stroke on these babies will be less severe. This is why we developed eTIPS - early therapy in perinatal stroke ("eTIPS").
Alongside piloting the eTIPS therapy, we recruited a similar number of babies who were not at risk of hemiplegic cerebral palsy. This was so that we could compare their movements. Only the babies with perinatal stroke did the eTIPS therapy. We measured how all the babies moved when we saw them each month. We used several assessments of movement to do this. Parents of babies in both groups also took
part in interviews to tell us what they thought about the therapy and the assessments. They completed questionnaires about their own wellbeing and self-perception of their parenting. Where babies had NHS therapists, we interviewed them to find out their views on the eTIPS approach.
This trial was designed to check if parents found eTIPS acceptable and if they could do the therapy (was it feasible?). It did not test whether the therapy improved outcomes, though we plan to test this at the next stage of our research.
A total of 27 babies (13 with perinatal stroke, of whom 8 were boys) were recruited to the trial. At 6 months, 11 (85%) of the 13 babies receiving eTIPS had completed the final assessment. Parents valued eTIPS and found it acceptable and workable. There were no adverse events related to the trial or the therapy. The Hand Assessment for Infants (a play-based assessment looking at how babies use their hands to
reach for, grasp and manipulate toys) was well tolerated by babies and highly valued by parents. The questionnaires did not suggest any adverse effect of engagement in eTIPS on the mental wellbeing of parents.
In summary, the eTIPS therapy was feasible to deliver and acceptable to families. We are still following-up the babies who received eTIPS, to two years of age. Next, we plan to undertake a trial with many more babies to find out whether eTIPS therapy improves hand function.
We would like to thank all participants for their contribution to this trialREC name
West of Scotland REC 5
REC reference
15/WS/0129
Date of REC Opinion
3 Jul 2015
REC opinion
Further Information Favourable Opinion