The Best Start Trial: A randomised controlled trial of ultra-early parent-administered physiotherapy for infants at high risk of cerebral palsy or motor delay.
Barbara R LucasJenny BowenCatherine MorganIona NovakNadia BadawiElizabeth ElliottGenevieve DwyerVenkatesha VenkateshaLisa A HarveyPublished in: Early human development (2024)
In this pilot trial, there was no clinically worthwhile effect of ultra-early parent-administered physiotherapy over usual care on the AIMS. However, the intervention was feasible for infants, acceptable to parents and parents perceived a benefit of treatment. Whilst this trial did not demonstrate treatment effectiveness using the AIMS, these findings should be interpreted cautiously because of the small sample size, the low responsivity of the AIMS to change in motor performance and the heterogeneity of the participants. Therefore, the intervention should not be abandoned on the basis of this trial, but rather further evaluated in a larger trial that addresses some of the learnings from this one.