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Effectiveness of the Carolina Curriculum versus standard care as an early intervention care package for the motor and cognitive outcomes of children who are at risk of developing cerebral palsy

Cerebral Palsy in Western Province, Sri Lanka: the clinical profiling and piloting an early intervention package.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2021/016
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Interventions

Study Setting - Ayati, National Center for Children with Disabilities, Thalagolla Road, Ragama. Method of Randomization - stratified randomization - based on the age of recruitment list 1) 3-4 m

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 3-6 months of age 2. Absent fidgety general movements on assessment 3. HINE (Hammesmith Infant Neurological Examination) score 40 -57 at the age of 3 - 6 months with or without abnormalities in MRI (magnetic Resonance Imaging) suggestive of an aetiology contributing towards cerebral palsy 4. HINE (Hammesmith Infant Neurological Examination) with increased number of asymmetries 5. Children of families who are willing to commit to follow up till 12 months of age

Exclusion criteria

Exclusion criteria: 1. Children who have a HINE (Hammesmith Infant Neurological Examination) score less than 40 2. Children with other major neurological or medical complications e.g. severe complex heart disease, seizure disorder. 3. Children who have undergone major interventions for their primary pathology or who are on major interventions to maintain life e.g.: VP(ventriculoperitoneal) shunt, Nasogastric tube, CPAP (Continuous Positive Airway Pressure) ventilation. 4. Children who are acutely ill and medically unstable. 5. Syndromic children 6. Infants who will be followed up at other peripheral hospitals. 7. Children who are attending services in more than one clinic. 8. Children with planned surgery or medical changes during the study which may affect their motor function

Design outcomes

Primary

MeasureTime frame
Bayley Scale of Infant Develpment vesion 111 - cognitive and motor outcome [baseline measurements will be taken at 3-6 months and after 6 months of intervention, i.e 9-12 months of age. ]

Secondary

MeasureTime frame
1. GMFM (Gross Motor Function Measure ): a standard assessment to evaluate the motor skills in children with cerebral palsy 2. HINE (Hammersmith Infant Neurological Examination): a neurological assessment including motor postures and reflexes in infants more than 3 months. [baseline measurements will be taken at 3-6 months and after 6 months of intervention 9-12 months of age. ] Canadian Occupation performance Measure - parent perception of performance of the child [ baseline measurements will be taken at 3-6 months and after 6 months of intervention, i.e 9-12 months of age. ]

Countries

Sri Lanka

Contacts

Public ContactThilini Madushika

Research Assistant

htmadushika@gmail.com+94115960050

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026