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 Lucas; Jenny Bowen; Catherine Morgan; Iona Novak; Nadia Badawi; Elizabeth Elliott; Genevieve Dwyer; Venkatesha Venkatesha; Lisa A Harvey

doi:10.1016/j.earlhumdev.2024.106111

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

Early Hum Dev. 2024 Nov:198:106111. doi: 10.1016/j.earlhumdev.2024.106111. Epub 2024 Sep 2.

Authors

Barbara R Lucas¹, Jenny Bowen², Catherine Morgan³, Iona Novak⁴, Nadia Badawi⁵, Elizabeth Elliott⁶, Genevieve Dwyer⁷, Venkatesha Venkatesha⁸, Lisa A Harvey⁹

Affiliations

¹ Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2065, Australia; Physiotherapy Department, Royal North Shore Hospital, St Leonards, NSW 2065, Australia; John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, St Leonards, Sydney, NSW, Australia. Electronic address: [email protected].
² Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2065, Australia; Department of Neonatology, Royal North Shore Hospital, Sydney, Australia.. Electronic address: [email protected].
³ Cerebral Palsy Alliance Research Institute, Discipline of Child and Adolescent Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.. Electronic address: [email protected].
⁴ Cerebral Palsy Alliance Research Institute, Discipline of Child and Adolescent Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.; Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.. Electronic address: [email protected].
⁵ Cerebral Palsy Alliance Research Institute, Discipline of Child and Adolescent Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.. Electronic address: [email protected].
⁶ Discipline of Child and Adolescent Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia; Kids Research, Sydney Childrens Hospitals Network, Westmead, Sydney, Australia. Electronic address: [email protected].
⁷ Western Sydney University, School of Health Sciences, Sydney, Australia. Electronic address: [email protected].
⁸ Northern Sydney Local Health District Executive, Sydney, NSW, Australia.. Electronic address: [email protected].
⁹ Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2065, Australia; John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, St Leonards, Sydney, NSW, Australia. Electronic address: [email protected].

PMID: 39244966
DOI: 10.1016/j.earlhumdev.2024.106111

Abstract

Background: It is unknown whether ultra-early physiotherapy commenced during neonatal intensive care unit admission is of value for optimising developmental outcomes in preterm/term infants at high-risk of cerebral palsy or motor-delay.

Aims: To determine whether ultra-early parent-administered physiotherapy to preterm/term high- risk infants commenced at earliest from 34-weeks post menstrual age, improves motor outcomes at 16-weeks corrected age (CA) compared to usual care.

Methods: Single-blind randomised controlled pilot study with 30 infant participants. The primary outcome was the Alberta Infant Motor Scale (AIMS) total score at 16-weeks CA. Secondary outcomes included (i) parent Depression Anxiety and Stress Score and Parent Perceptions Survey at 16-weeks CA; and (ii) Bayley Scales of Infant Development at 12-months CA.

Results: There were no clinically worthwhile effects at 16-weeks CA on the AIMS (mean between-group difference, 95% CI: -0.2, -2.4 to 2.0) or most secondary outcomes. However, the parents' "perception of treatment effectiveness" and "perception of change" favoured the experimental group.

Conclusions: 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.

Keywords: Cerebral palsy; Motor delay; Neuroplasticity; Physiotherapy; Randomised controlled trial; Ultra-early intervention.

Publication types

Randomized Controlled Trial

MeSH terms

Cerebral Palsy*
Child Development
Developmental Disabilities
Female
Humans
Infant
Infant, Newborn
Infant, Premature
Male
Parents* / psychology
Physical Therapy Modalities*
Pilot Projects
Single-Blind Method