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Harnessing neuroplasticity to improve motor performance in infants with cerebral palsy: a study protocol for the GAME
Catherine Morgan1, Nadia Badawi2,3, Roslyn N Boyd4
1Cerebral Palsy Alliance Research Institute, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, New South Wales, Australia cmorgan@cerebralpalsy.org.au.
Insights
This study investigates the Goals-Activity-Motor Enrichment (GAME) approach for infants with cerebral palsy (CP). Early intervention with GAME aims to improve motor and cognitive skills in young children with CP.
Area of Science:
- Pediatrics
- Neurology
- Developmental Psychology
Background:
- Cerebral palsy (CP) is the most common childhood physical disability globally.
- Historically, CP diagnosis occurred later (12-24 months), limiting early intervention research.
- Effective early interventions are crucial for improving motor outcomes in children with CP.
Purpose of the Study:
- To evaluate the efficacy of the Goals-Activity-Motor Enrichment (GAME) approach in infants with suspected or confirmed CP.
- To determine if early and sustained GAME intervention improves motor and cognitive skills.
- To provide evidence for early intervention strategies in pediatric cerebral palsy.
Main Methods:
- Evaluator-blinded, randomized controlled trial involving infants aged 3-6.5 months.
- Participants diagnosed with CP or at high risk for CP.
- Intervention group received weekly home therapy sessions and daily home program; control group received usual care until age 2.
Main Results:
- The study aims to detect a 0.5 SD difference in motor skills at 2 years using 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 will also be conducted.
Conclusions:
- This trial will provide critical data on the effectiveness of an early, intensive intervention for infants with cerebral palsy.
- Findings are expected to inform clinical practice and guidelines for early intervention in CP.
- Dissemination through publications, conferences, and consumer websites will ensure broad impact.
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.
