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Published on: August 8, 2011
Feasibility trial of an early therapy in perinatal stroke (eTIPS)
Anna Purna Basu1,2, Janice Pearse3, Rose Watson4
1Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, NE1 7RU, UK. Anna.basu@ncl.ac.uk.
Insights
The early Therapy In Perinatal Stroke (eTIPS) intervention, a parent-delivered therapy for infants with perinatal stroke, was found to be feasible and acceptable to families. Further trials will assess its efficacy in improving motor outcomes for infants at risk of unilateral cerebral palsy.
Area of Science:
- Neuroscience
- Pediatrics
- Rehabilitation Medicine
Background:
- Perinatal stroke (PS) affects approximately 1 in 2300 infants, often leading to unilateral cerebral palsy (UCP).
- Preterm infants with unilateral haemorrhagic parenchymal infarction (HPI) also face an increased risk of UCP.
- Current standardized early therapeutic approaches for these conditions are lacking, despite the potential for early intervention to enhance neuroplasticity.
Purpose of the Study:
- To evaluate the feasibility and acceptability of the 'early Therapy In Perinatal Stroke' (eTIPS) intervention.
- To assess the potential of eTIPS to positively influence activity-dependent plasticity in the developing nervous system.
- Ultimately, to determine if eTIPS can improve motor outcomes in infants affected by perinatal stroke or HPI.
Main Methods:
- A feasibility trial conducted in North-East England (August 2015-September 2017) involving infants with PS or HPI, their carers, and therapists.
- The intervention involved a parent-delivered, lateralised therapy approach from term equivalent age to 6 months corrected age.
- Feasibility was measured by recruitment and retention rates; acceptability was assessed via parental questionnaires (including WEBWMS), observations, and interviews. Motor function was evaluated using the Hand Assessment for Infants (HAI).
Main Results:
- Of 20 screened infants, 14 met inclusion criteria, and 13 enrolled; 11 (85%) completed the 6-month assessment.
- Parents reported the intervention as acceptable and workable, with no adverse events. Parental mental wellbeing was not negatively affected.
- The Hand Assessment for Infants (HAI) was well-tolerated and valued by parents. Data from 12 typically developing infants were analyzed for comparison.
Conclusions:
- The eTIPS intervention demonstrated feasibility and acceptability among families of infants with perinatal stroke or HPI.
- The study supports the potential of parent-delivered, early, lateralised therapy.
- A multicentre randomised controlled trial is planned to investigate the efficacy of the eTIPS intervention.
Background:
Perinatal stroke (PS) affects up to 1/2300 infants and frequently leads to unilateral cerebral palsy (UCP). Preterm-born infants affected by unilateral haemorrhagic parenchymal infarction (HPI) are also at risk of UCP. To date no standardised early therapy approach exists, yet early intervention could be highly effective, by positively influencing processes of activity-dependent plasticity within the developing nervous system including the corticospinal tract. Our aim was to test feasibility and acceptability of an "early Therapy In Perinatal Stroke" (eTIPS) intervention, aiming ultimately to improve motor outcome.
Methods:
Design: Feasibility trial, North-East England, August 2015-September 2017. Participants were infants with PS or HPI, their carers and therapists. The intervention consisted of a parent-delivered lateralised therapy approach starting from term equivalent age and continuing until 6 months corrected age. The outcome measures were feasibility (recruitment and retention rates) and acceptability of the intervention (parental questionnaires including the Warwick-Edinburgh Mental Wellbeing Scale (WEBWMS), qualitative observations and in-depth interviews with parents and therapists). We also reviewed clinical imaging data and undertook assessments of motor function, including the Hand Assessment for Infants (HAI). Assessments were also piloted in typically developing (TD) infants, to provide further information on their ease of use and acceptability.
Results:
Over a period of 18 months we screened 20 infants referred as PS/HPI: 14 met the inclusion criteria and 13 took part. At 6 months, 11 (85%) of those enrolled had completed the final assessment. Parents valued the intervention and found it acceptable and workable. There were no adverse events related to the intervention. We recruited 14 TD infants, one of whom died prior to undertaking any assessments and one of whom was subsequently found to have a condition affecting neurodevelopmental progress: thus, data for 12 TD infants was analysed to 6 months. The HAI was well tolerated by infants and highly valued by parents. Completion rates for the WEBWMS were high and did not suggest any adverse effect of engagement in eTIPS on parental mental wellbeing.
Conclusion:
The eTIPS intervention was feasible to deliver and acceptable to families. We plan to investigate efficacy in a multicentre randomised controlled trial.
Trial Registration:
ISRCTN12547427 (registration request submitted 28/05/2015; retrospectively registered, 30/09/2015).
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