Effectiveness of GAME (Goals Activity Motor Enrichment) for infants at high risk of cerebral palsy

Not Applicable

Recruiting

• Conditions: cerebral palsy; Neurological - Other neurological disorders

• Registration Number: ACTRN12617000006347
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-03
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peabody Developmental Motor Scales - second edition[Primary end point is 24 months, interim measures will be taken at 12 months]