The motor, social emotional and cognitive outcomes of infant at risk of neuromotor impairment disability, receiving Learning through Everyday Activities with the Parents of Children with Cerebral Palsy (LEAP-CP) programme and standard care: A randomized control trial
- Conditions
- Cerebral Palsy
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
Infants aged 3 months to <6 months identified as at high-risk of CP:
•Extremely preterm (gestational age <28 weeks)
•Extremely low birthweight (birth weight <1000 g)
•Neonatal encephalopathy
•Neurological risk factors (e.g. congenital disabilities, seizures, stroke)
•General Movements Absent fidgety” score + abnormal brain MRI/CUS indicating cerebral palsy;
•General Movements Absent fidgety” score + Hammersmith Infant Neurological Evaluation (HINE) score <57 at 12-weeks / <59 26-weeks of age;
•Abnormal brain MRI/CUS indicating cerebral palsy + Hammersmith Infant Neurological Evaluation score <57 at 3 months of age/ <59 at 6 months of age. (infants with evidence of unilateral injury and clinical asymmetry indicating hemiplegia, HINE scores > 57 will be accepted as per literature).
•Infants with lethal abnormalities
•Infants with congenital conditions not associated with cerebral palsy (e.g. Down’s Syndrome) Infants with complex medical conditions requiring acute medical care
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean score differences in Peabody Developmental Motor Scales, edition 2 (PDMS-2). The assessment is composed of six subtests that measure interrelated motor abilities that develop early in life. [Pre-intervention (T0)<br>Postintervention <br>T1=baseline age + 30 weeks <br>T2 = 18 months corrected age]<br> The mean score differences in Toddler Social Emotional Assessment (ITSEA). The tool measures multiple dimensions of social-emotional problems and competencies. [Pre-intervention (T0)<br>Postintervention <br>T1=baseline age + 30 weeks <br>T2 = 18 months corrected age]<br>The primary caregiver outcome will be assessed through the Depression, Anxiety, Stress Scale – Short Form (DASS). DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. [Pre-intervention (T0)<br>Postintervention <br>T1=baseline age + 30 weeks <br>T2 = 18 months corrected age]<br>
- Secondary Outcome Measures
Name Time Method Mean score difference in Emotional Availability Scales (EAS), Emotional Availability-Self Report (EA-SR) and the Infant Toddler Quality of Life Questionnaire TM (ITQOL-SF47). These tools will assess behavioral and emotional problems of the study participants. [Pre-intervention (T0)<br>Postintervention <br>T1=baseline age + 30 weeks <br>T2 = 18 months corrected age]<br>Mean score differences in the following tools which assesses functional outcomes of the participants: Canadian Occupational Performance Measure (COPM), the Pediatric Evaluation of Disability Inventory – Computer Adaptive Test (PEDI-CAT), the Bayley Scales of Infant Development III (BSID-III) and the Preverbal Visual Assessment (PreVIAS). [Pre-intervention (T0)<br>Postintervention <br>T1=baseline age + 30 weeks <br>T2 = 18 months corrected age]<br>