It is important to note, however, that evidence for the effectiveness of general EI to improve cognition is well established for the more heterogeneous "high risk" groups. Most systematic reviews conclude that EI approaches currently in use for CP do not have any effect on motor outcomes greater than what would be expected as a result of maturation. As a result it is virtually impossible to ascertain the effects of EI on the motor outcomes of infants with CP. In many of these studies the proportion of children who actually go on to be diagnosed with CP are relatively small resulting in underpowered type II trials for CP. Rather heterogeneous infants are included in EI studies and labelled "high risk" because they were preterm, display delayed development or had complex social issues. Early intervention and early enrichmentĮarly intervention (EI) studies have typically not used this combination of assessment tools to recruit homogenous samples of infants at high risk of CP. For the preterm population, the combination of GMs and evidence of white matter injury on MRI predicts CP at 3 months with 100% accuracy. GMs is now the gold standard tool for early diagnosis of CP because of higher specificity and sensitivity than other traditional tests such as neurological examinations, cranial ultrasound and MRI. In recent years, research into the predictive validity of Prechtl's Qualitative Assessment of General Movements (GMs) has allowed earlier diagnosis of high risk of CP to be reliably made at 3 months of age. Intervention for infants with brain injuries aims to optimise these neuroplastic mechanisms. The field of neuroscience has repeatedly demonstrated the plasticity of the infant brain and persistence of neurogenesis and activity- dependent plasticity are two of the basic mechanisms at work. Furthermore children with CP reach approximately 90% of their gross motor potential by age 5 (or younger for more severely impaired), but for 40% of this critical window the ultimate severity of their condition is largely unknown, however severity itself is a likely predictor of responsivity to early intervention. Wait and see monitoring can mean brain injured infants do not always receive intervention in the most crucial period of brain development. First, because only half of infants with CP have clearly identifiable risks in the newborn period, for example prematurity or neonatal encephalopathy (NE), and second, because not all infants with prematurity or NE will go on to have CP. Late diagnosis, conservative "wait and see" monitoring and late referral to early intervention is the prevailing norm for two main reasons.
ACTIVATE NEURO PROGRAMMER 2 REVIEW TRIAL
This trial is registered on the Australian New Zealand Clinical Trial register: ACTRN12611000572965.Ĭerebral palsy (CP) is the most common physical disability of childhood with a prevalence of 2.1/1000 live births. 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. Parent well-being will be monitored using the Depression Anxiety and Stress Scale. 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. The primary outcome measure will be the Peabody Developmental Motor Scale second edition. Primary endpoint measures will be taken 16 weeks after intervention commences with the secondary endpoint at 12 months and 24 months corrected age. The intervention aims to optimize motor function and engage parents in developmental activities aimed at enriching the home learning environment. A physiotherapist and occupational therapist will deliver home-based GAME intervention at least fortnightly until the infant's first birthday. 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.
Methods/designĪ two group, single blind randomised controlled trial (n = 30) will be conducted. 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. Systematic reviews indicate early intervention trials rarely demonstrate efficacy for improving motor outcomes but environmental enrichment interventions appear promising. Cerebral palsy is the most common physical disability of childhood and early detection is possible using evidence based assessments.