None listed
Conditions
Brief summary
Each year, 600 Australians are diagnosed with cerebral palsy with a $4 billion annual socioeconomic burden. One third never walk. The National Disability Insurance Scheme ranks early intervention to improve disability as its top priority. We have developed an early training intervention ("GAME" Goals Activity Motor Enrichment) based on the key neuroscience principles of activity dependent plasticity and enriched environments and on successful training interventions known to work in older children with cerebral palsy and adults post stroke. GAME is the only published protocol of an infant friendly early, intense, specific training intervention grounded in contemporary neuroscience, tested for safety and early efficacy, and is acceptable to parents. This new pragmatic, single blind randomised controlled trial (RCT) in 300 infants with cerebral palsy or at high risk of cerebral palsy aims to evaluate the effects of “GAME” versus traditional passive early intervention on gross and fine motor skills at two years of age. We will also evaluate the secondary outcomes of neuroplasticity on MRI, cognitive skills and quality of life. In this pragmatic trial, infants will receive experimental GAME training (once weekly therapist provided+ daily parent provided) versus control (traditional therapy alone). Both groups will be dose matched according to the standard National Disability Insurance Scheme early intervention funding package. Experimental and control treatments will continue until the infant’s 2nd birthday. Assessments will be carried out at baseline, prior to randomisation and at 1 and 2 years of age (corrected for prematurity). The expected clinical outcomes of our trial are that infants who received our intervention will have significant and lasting motor and cognitive gains that lessen the severity of their cerebral palsy and improve their quality of life.
Interventions
Intervention: GAME (Goals Activity Motor enrichment) has 3 key elements
1. Motor training. Motor goals are first identified by parents and then the therapist identifies and explains to families the factors limiting performance. Training is then designed to target goal achievement. Training is goal-oriented, relevant, task specific, providing the necessary repetition required to learn to perform the new goal behaviours independently.
2. Parent coaching in motor training. During the dace to fa
Intervention: GAME (Goals Activity Motor enrichment) has 3 key elements 1. Motor training. Motor goals are first identified by parents and then the therapist identifies and explains to families the factors limiting performance. Training is then designed to target goal achievement. Training is goal-oriented, relevant, task specific, providing the necessary repetition required to learn to perform the new goal behaviours independently. 2. Parent coaching in motor training. During the dace to face sessions, parents are coached in how to provide motor training and cognitive stimulation within their child’s natural playtime. They are educated about usual developmental trajectories and how to advance progress. 3. Environmental enrichment. GAME is provided in the natural home environment where training is personalised to the infant’s enjoyment – translating to more intense, specific and relevant practice. GAME intervention enriches the: (a) physical environment by setting up the home with activities and materials entice infant-generated motor practice at the appropriate level of challenge; (b) cognitive environment by encouraging infant problem solving and self-correction of errors; (c) sensory environment by providing evidence-based interventions that improve backdrop capacity for learning; and (d) social environment by coaching parents to be sensitive, responsive and communicative to infant cues. This intervention is designed to be individualised to the child and family DOSE: intervention sessions will be offered weekly from enrolment until age 2 years (corrected for prematurity). A maximum of 91 sessions (depending on age at enrolment) will be provided. Each session will be about 1 hour. Parents will carry out a home programme to increase the dose but it will be up to the parents how much they do based on family ecology and preferences. WHO: GAME intervention will be provided by a physiotherapist and/or occupational therapist. The therapists will design the home program in collaboration with the family and it will be provided in written format. FIDELITY: Intervention fidelity will be assessed by the chief investigators using a fidelity checklist, appraisal of home programs and site visits
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
3 Months to 6 Months
Healthy volunteers
No
Inclusion criteria
(a) Aged 3-6.5 months corrected for prematurity; (b) Discharged home from hospital; and (c) Diagnosis of cerebral palsy OR (d) diagnosis of “high risk of cerebral palsy” via: (i) General Movements “Absent fidgety” score + abnormal brain MRI/CUS indicating cerebral palsy; OR (ii) General Movements “Absent fidgety” score + Hammersmith Infant Neurological Examination score <57@ 3 months / <59 6 months; OR (iii) Abnormal brain MRI/CUS indicating cerebral palsy + Hammersmith Infant Neurological Examination score <57@ 3 months / <59@ 6 months of age.; OR (iv) imaging evidence of a unilateral brain injury on MRI/CUS + clinical signs of asymmetry + Hammersmith Infant Neurological Examination score in optimal range
Exclusion criteria
(a) Drug resistant epilepsy meeting the International League Against Epilepsy (ILAE) criteria; (b) Severe vision impairment (unable to fix and follow in good light); (c) medically fragile preventing safe child-active participation in training; and (d) living in remote location inaccessible by study personnel for home visits.
Outcome results
None listed