None listed
Conditions
Brief summary
Infants “at risk” of cerebral palsy (CP) because of premature birth or early brain injury can now be diagnosed early. Early diagnosis allows early intervention to begin at the critical period when the brain is rapidly developing. It has not yet been clearly demonstrated that current early intervention programmes can improve the motor development of infants "at risk" of CP. "Goal Directed Training" (GDT) is one newer intervention which has been shown to be effective in older children. GDT is based on motor learning principles and involves designing therapy around the family's goals and engaging them to work with their child in their real life environments. A recent systematic review and meta analysis of the effect of environmental enrichment (EE) on infants at high risk of CP demonstrated a small favourable effect for enrichment. Using environmental enrichment strategies, specifically for motor development is a focus of this intervention approach. Our pilot study (n=13) of 12 weeks of goal directed, motor enrichment intervention demonstrated a significant advantage on the Peabody Developmental Motor Scale for the experimental group. This study aims to test the effectiveness of GDT and enriched home environments on infants with cerebral palsy. The study is a 2 group RCT (n=30) which compares the effectiveness of GDT and enriched environments with standard care. Participants will be infants 3-6 months of age at enrolment, determined to be at "high risk" of cerebral palsy using the Qualitative Assessment of General Movements (GMs). All infants will receive therapy in this trial until their first birthday. Outcomes of interest include attainment of motor skills, parental emotional well being and quality of the home environment for motor learning.
Interventions
Goal directed training - is a neuroplastic and activity-based approach to rehabilitation.
The therapy approach involves repeated practice of real-life tasks the infant wants to do for example, sitting or reaching for toys. Goal oriented approaches for achieving functional outcomes (sometimes called “functional therapy”) are now widely accepted as best practice for older children with cerebral palsy, are grounded in dynamic systems theory and are supported by Grade A evidence . Influenced by the
Goal directed training - is a neuroplastic and activity-based approach to rehabilitation. The therapy approach involves repeated practice of real-life tasks the infant wants to do for example, sitting or reaching for toys. Goal oriented approaches for achieving functional outcomes (sometimes called “functional therapy”) are now widely accepted as best practice for older children with cerebral palsy, are grounded in dynamic systems theory and are supported by Grade A evidence . Influenced by the wealth of literature regarding family centred care, these approaches focus on collaborative goal setting with parents. Goal-limiting factors are identified by holistic assessment of the child, the task being trained and the environment in which learning occurs . An intervention plan is then developed on the basis of the assessment and outcomes evaluated. This approach, has been shown to be effective in adults with acquired brain injury and can be effectively delivered via a home program for older children with cerebral palsy. Enriched home environments are environments where the parent is actively and positively engaged with the child, to facilitate learning. Motor enriched learning environments are created and dynamically adapted so that the appropriate level of learning challenge is provided. Parents are trained in motor task analysis and are coached in appropriate strategies to enhance their child’s development. Infants in the experimental group for this study will receive the GDT and motor enrichment interventions in a home based setting. Trained therapists will deliver intervention in individual sessions with a parent present. Frequency will be at least fortnightly for approximately 90 minutes each session. In addition, a home programme will be provided.
Sponsors
University of Notre Dame Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
9 Weeks to 6 Months
Healthy volunteers
Yes
Inclusion criteria
1.Diagnosis of Cerebral Palsy or at risk of Cerebral Palsy using Prechtl’s General Movement Assessment (GMs) and confirmatory neuroimaging where available and aged less than 18 weeks post term age OR over 18 weeks and up to 6 months with neuroimaging evidence of brain injury; 2. Parent/guardian consent given 3. Discharged from hospital
Exclusion criteria
1. Severe genetic abnormalities as coexisting medical conditions may make participation in the study difficult 2. Not living in a remote location which precludes investigators visiting
Outcome results
None listed