GAME (Goals - Activity - Motor Enrichment): protocol of a single blind randomised controlled trial of motor training, parent education and environmental enrichment for infants at high risk of cerebral palsy

Families collaborate with the therapists to determine a set of goals for their child's development [25]. Typically the goals would relate to motor development but might also include health related concerns known to affect development such as sleeping and feeding. The therapist plays an important role in helping parents set realistic and appropriately time framed goals. As goals are attained the family and therapist work together to develop new goals. These parent identified goal areas are targeted for practice during therapy sessions and built into a home programme (HP).

The motor learning component of the intervention is based on the principles of motor learning and dynamic systems theory [26],[27]. Therapist assessment of the relative contributions of weakness, selective motor control and altered tone to difficulties in goal achievement are discussed with the family and solutions are identified and tried [28]. Parents are encouraged to use their knowledge of their child's play preferences to elicit self-generated motor activity. Minimal manual guidance is provided when required and withdrawn as soon as the child has the idea of the movement or begins to demonstrate the ability to recruit a successful muscle action or sequence. Parents are coached in understanding "missing components" of the desired action and problem solve with the therapists ways of simplifying the task to enable at least part task attainment.

Motor tasks are scaffolded, so that the infant can always actively complete at least a part of the task [29]. As performance improves, the motor challenge is increased by altering the task or environment to encourage problem solving. Manual assistance is reduced or withdrawn as soon as the infant demonstrates self-initiated progress with the task; ensuring self-generated motor activity is promoted in all practice sessions. Once a motor skill is learned, variability of practice is introduced to increase the complexity and generalizability of the skill [30]. Early weightbearing and sit to stand from the parents' lap are routinely included for each infant even if standing is not identified as a specific goal. Rehabilitation research in older children and adults with brain injuries suggest that functional weight bearing exercises can both improve motor control and provide strength training [26]. Given that the expected impairments of CP include weakness and reduced selective motor control, early activation of muscles of the lower limb using both concentric and eccentric exercise could enhance the development of upright mobility. Similarly, practice of reaching and grasping a variety of objects is also a standard part of motor training for all infants in order to expose the infants who are expected to be delayed, to a variety of objects to advance grasp and reach behaviours [31]. Modified constraint induced movement therapy and/or bimanual training is used when asymmetrical hand function is evident.

Practice schedules are discussed and designed based on family time constraints. A written HP, illustrated with photographs and related to parent identified goals, weightbearing and reach and grasp is provided. The HP describes parenting strategies, environmental enrichments and child-activities as per published guidelines on effective home programmes [32]. Activities in the HP are organised into those in which the carer plays an active role and those where practice can be "set up" for the infant to carry-out independently. The HP is updated as goals are attained.

Parent education is known to be an important component of early intervention that is grounded in family centred practice [33]. Since most of the infant's active practice opportunities are provided in the child' daily routines, parent education is vital [34]. In GAME intervention, parents are coached to identify their child's voluntary attempts to move and self-regulate, plus understand the usual trajectory of emergent motor skills and how to stimulate progress. Parents are trained in simple motor task analysis and coached in appropriate strategies to enhance their child's development both at a specific goal level and in general early learning and development principles. Parents are taught to optimise the best use of their infants' "awake" time and the naturally occurring opportunities for learning. Learning optimisation includes both parent-directed and structured practice of desired motor tasks, where the parent role is integral to the child's learning (e.g. creating repetitions) and constructing opportunities for independent play (e.g. playing alone with motor enriching toys set up for the child). Parents are encouraged to both observe the therapist eliciting a motor behaviour from the baby and to attempt it themselves. Specific feedback, in a warm and supportive context, is given to parents to enable them to tease out why some attempts were successful for the baby and others weren't. As new motor skills emerge parents are coached in strategies to increase the challenge of the task; for example removal of support or the introduction of more complex toys. The importance of allowing trial and error during practice is discussed and parents are encouraged to devise their own activities to enhance goal attainment. Prognostic information is given when possible as well as evidence based information regarding sleeping, feeding and responsive parenting.

It is clear that many aspects of a child's environment influence his or her motor, cognitive and social-emotional outcomes. Parental responsivity, a variety of daily experiences, equipment use and the structure of the physical space are all known to influence child development [35]-[37]. In GAME, all visits are conducted within the family's home and deliberate attention is paid to aspects of the home environment to enhance developmental outcomes. This enrichment includes assistance in setting up motor enriched play environments to promote child self-generated movements, exploration and task success. This includes instruction in careful toy selection "matched" to the desired motor task, plus physical set up of areas for practicing and repeating activities related to the identified goal areas, weightbearing, and reaching and grasping tasks. Conventional baby equipment (e.g. highchairs, toys) already purchased by the family is used wherever possible. The whole environment for motor learning is taken into account and therefore intervention may also include: (a) evidence-based early learning stimulation and role modelling to enhance cognitive and language development (e.g. reading books to children, limiting passive television watching); (b) optimising sleep hygiene; and (c) feeding interventions (e.g. anti-reflux medications) to ensure adequate caloric nutrition and pain-free backdrops for learning. The importance of variable daily experiences for infants is deliberately addressed and support given when parents articulate difficulty leaving the house. Siblings and extended family members are also actively encouraged to take part in the HP and therapy sessions to promote: family knowledge; family acceptance; family wellbeing; repetition of learning opportunities; and provide a natural source of varied social interaction for the infant. Parent well-being is openly discussed and support given to parents to access appropriate services when required.

Home visits from the GAME treating therapists are offered weekly initially and then frequency of intervention negotiated with each family around their preferences, availability and family resources required to carry out the intervention with fidelity. Visits are approximately 60 to 90 minutes duration.