Abstract
BackgroundCerebral palsy is the most common physical disability of childhood and early detection is possible using evidence based assessments. Systematic reviews indicate early intervention trials rarely demonstrate efficacy for improving motor outcomes but environmental enrichment interventions appear promising. This study is built on a previous pilot study and has been designed to assess the effectiveness of a goal - oriented motor training and enrichment intervention programme, “GAME”, on the motor outcomes of infants at very high risk of cerebral palsy (CP) compared with standard community based care.Methods/designA two group, single blind randomised controlled trial (n = 30) will be conducted. Eligible infants are those diagnosed with CP or designated “at high risk of CP” on the basis of the General Movements Assessment and/or abnormal neuroimaging. A physiotherapist and occupational therapist will deliver home-based GAME intervention at least fortnightly until the infant’s first birthday. The intervention aims to optimize motor function and engage parents in developmental activities aimed at enriching the home learning environment. Primary endpoint measures will be taken 16 weeks after intervention commences with the secondary endpoint at 12 months and 24 months corrected age. The primary outcome measure will be the Peabody Developmental Motor Scale second edition. Secondary outcomes measures include the Gross Motor Function Measure, Bayley Scales of Infant and Toddler Development, Affordances in the Home Environment for Motor Development – Infant Scale, and the Canadian Occupational Performance Measure. Parent well-being will be monitored using the Depression Anxiety and Stress Scale.DiscussionThis paper presents the background, design and intervention protocol of a randomised trial of a goal driven, motor learning approach with customised environmental interventions and parental education for young infants at high risk of cerebral palsy.Trial registrationThis trial is registered on the Australian New Zealand Clinical Trial register: ACTRN12611000572965.
Highlights
Cerebral palsy is the most common physical disability of childhood and early detection is possible using evidence based assessments
Children with cerebral palsy (CP) reach approximately 90% of their gross motor potential by age 5, but for 40% of this critical window the ultimate severity of their condition is largely unknown [3], severity itself is a likely predictor of responsivity to early intervention
It is important to note, that evidence for the effectiveness of general Early intervention (EI) to improve cognition is well established for the more heterogeneous “high risk” groups [11]. It remains to be determined whether intervention approaches that are goal-oriented and involve active motor training [12,13] currently used in older children with CP are applicable to infants with a small emergent motor repertoire
Summary
This paper presents the background, design and intervention protocol of a randomised trial of a goal driven, motor learning approach with customised environmental interventions and parental education for young infants at high risk of cerebral palsy. Trial registration: This trial is registered on the Australian New Zealand Clinical Trial register: ACTRN12611000572965
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