Harnessing neuroplasticity to improve motor performance in infants with cerebral palsy: a study protocol for the GAME randomised controlled trial

Catherine Morgan; Nadia Badawi; Roslyn N Boyd; Alicia J Spittle; Russell C Dale; Adrienne Kirby; Rod W Hunt; Koa Whittingham; Kerstin Pannek; Rachael L Morton; William Tarnow-Mordi; Michael C Fahey; Karen Walker; Kristina Prelog; Catherine Elliott; Jane Valentine; Andrea Guzzetta; Shannon Olivey; GAME study team; Iona Novak

doi:10.1136/bmjopen-2022-070649

Harnessing neuroplasticity to improve motor performance in infants with cerebral palsy: a study protocol for the GAME randomised controlled trial

BMJ Open. 2023 Mar 10;13(3):e070649. doi: 10.1136/bmjopen-2022-070649.

Authors

Catherine Morgan¹, Nadia Badawi^{2

3}, Roslyn N Boyd⁴, Alicia J Spittle⁵, Russell C Dale⁶, Adrienne Kirby⁷, Rod W Hunt^{8

9}, Koa Whittingham^{10

11}, Kerstin Pannek¹², Rachael L Morton⁷, William Tarnow-Mordi¹³, Michael C Fahey⁸, Karen Walker^{14

15}, Kristina Prelog¹⁶, Catherine Elliott^{17

18}, Jane Valentine¹⁹, Andrea Guzzetta^{20

21}, Shannon Olivey⁹; GAME study team; Iona Novak^{22

23}

Collaborators

GAME study team:
Anna Te Velde, Ashleigh Hines, Esther Tantsis, Emma Stanton, Monica Toohey

Affiliations

¹ Cerebral Palsy Alliance Research Institute, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, New South Wales, Australia cmorgan@cerebralpalsy.org.au.
² Cerebral Palsy Alliance Research Institute, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, New South Wales, Australia.
³ Grace Centre for Newborn Intensive Care, Sydney Children's Hospital Network, Sydney, New South Wales, Australia.
⁴ The Faculty of Medicine, Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia.
⁵ Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Victoria, Australia.
⁶ Children's Hospital at Westmead Clinical School, The University of Sydney, Sydney, New South Wales, Australia.
⁷ Faculty of Medicine and Health, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
⁸ Department of Paediatrics, Monash University, Clayton, Victoria, Australia.
⁹ Cerebral Palsy Alliance, Forestville, New South Wales, Australia.
¹⁰ Queensland Cerebral Palsy Research Centre, The University of Queensland, Brisbane, Queensland, Australia.
¹¹ The Faculty of Medicine, Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.
¹² Health and Biosecurity, The Australian E-Health Research Centre, CSIRO, Brisbane, Queensland, Australia.
¹³ NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
¹⁴ Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
¹⁵ RPA Newborn Care, Sydney Local Health District, Camperdown, New South Wales, Australia.
¹⁶ Medical Imaging Department, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
¹⁷ School of Allied Health, Curtin University, Perth, Western Australia, Australia.
¹⁸ Telethon Kids Institute, Nedlands, Western Australia, Australia.
¹⁹ Paediatric Rehabilitation, Princess Margaret Hospital for Children, Perth, Western Australia, Australia.
²⁰ Department of Developmental Neuroscience, IRCCS Stella Maris, University of Pisa, Pisa, Toscana, Italy.
²¹ Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Toscana, Italy.
²² Faculty of Medicine & Health, The University of Sydney, Sydney, New South Wales, Australia.
²³ Faculty of Medicine & Health, Cerebral Palsy Alliance Research Institute, Specialty of Child & Adolescent Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.

Abstract

Introduction: Cerebral palsy (CP) is the most common physical disability of childhood worldwide. Historically the diagnosis was made between 12 and 24 months, meaning data about effective early interventions to improve motor outcomes are scant. In high-income countries, two in three children will walk. This evaluator-blinded randomised controlled trial will investigate the efficacy of an early and sustained Goals-Activity-Motor Enrichment approach to improve motor and cognitive skills in infants with suspected or confirmed CP.

Methods and analysis: Participants will be recruited from neonatal intensive care units and the community in Australia across four states. To be eligible for inclusion infants will be aged 3-6.5 months corrected for prematurity and have a diagnosis of CP or 'high risk of CP' according to the International Clinical Practice Guideline criteria. Eligible participants whose caregivers consent will be randomly allocated to receive usual care or weekly sessions at home from a GAME-trained study physiotherapist or occupational therapist, paired with a daily home programme, until age 2. The study requires 150 participants per group to detect a 0.5 SD difference in motor skills at 2 years of age, measured by the Peabody Developmental Motor Scales-2. Secondary outcomes include gross motor function, cognition, functional independence, social-emotional development and quality of life. A within-trial economic evaluation is also planned.

Ethics and dissemination: Ethical approval was obtained from the Sydney Children's Hospital Network Human Ethics Committee in April 2017 (ref number HREC/17/SCHN/37). Outcomes will be disseminated through peer-reviewed journal publications, presentations at international conferences and consumer websites.

Trial registration number: ACTRN12617000006347.

Keywords: community child health; paediatric neurology; rehabilitation medicine.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Australia
Cerebral Palsy* / psychology
Child
Cognition
Humans
Infant
Infant, Newborn
Neuronal Plasticity
Quality of Life
Randomized Controlled Trials as Topic

Associated data

ANZCTR/ACTRN12617000006347