Optimising motor learning for infants at high risk of cerebral palsy using environmental and goal oriented interventions

Phase 2

Completed

• Conditions: Cerebral palsy; Physical Medicine / Rehabilitation - Physiotherapy; Neurological - Other neurological disorders

• Registration Number: ACTRN12611000572965
• Lead Sponsor: niversity of Notre Dame Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peabody Developmental Motor Scale-Second edition[Baseline before randomisation, 16 weeks after enrolment, 12 months and 24 months]

Secondary Outcome Measures

Name	Time	Method
Gross motor skills as measured by the Gross Motor Function Measure (GMFM)[12 and 24 months only];Parental stress, depression and anxiety as measured by the Depression and Anxiety Stress Scale (DASS)[Baseline before randomisation and 16 weeks post enrolment and at 12 and 24 months after intervention];Child's performance with goals and parental satisfaction with goal performance as measured by the Canadian Occupational Performance Measure (COPM)[Baseline before randomisation and 16 weeks post enrolment and at 12 and 24 months after intervention];Cognitive and general motor performance as measured by the Bayley Scales of Infant development (Bayleys-III)[12 and 24 months];Affordances in the Home Environment for Motor Development- Infant Scale[Baseline before randomisation and at 12 months corrected age];Hand Assessment of Infants[Baseline before randomisation, 16 weeks after enrolment and 12 months of age (corrected).]