Home » Trials » SLCTR/2021/016

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


SLCTR Registration Number


Date of Registration

27 Jun 2021

The date of last modification

Aug 07, 2023

Application Summary

Scientific Title of Trial

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

Public Title of Trial

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

Disease or Health Condition(s) Studied

Cerebral Palsy

Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority


Trial Details

What is the research question being addressed?

Does Carolina Curriculum improve motor and cognitive functions better than standard care in children who are at risk of developing cerebral palsy?

Type of study


Study design


Randomized controlled trial


Single blinded : Outcome assessors


Standard therapy/practice





Study Phase

Not Applicable

Intervention(s) planned

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 months list 2) 4.1-5 months list 3 ) 5.1-6 months.

Eligible children stratified according to the age groups will be randomized to intervention and standard care packages. Unit of Randomization : intervention or standard care Method of sequence generation - The three lists will be allocated separately. Allocation will be done by a computer generated programme, random numbers will be issued by a person who is not involved in delivering the study interventions.
Method of allocation concealment - Allocation concealment is done using the sealed envelope at the time of the recruitment. It will be opened by an independent administration officer attached to the Ayati center but who is not involved in delivering the intervention and will be directed to the relevant therapist for the specific intervention Carolina Curriculum or Standard Care.

Intervention – Carolina Curriculum is an early intervention care package. Therapists will assess the child with the caregiver to identify the next targeted activity level combining two or more objectives into several specific activities with the materials which can be found within the home environment and that will be the intervention plan for each child. All the activities will be performed during weekly sessions with the therapist and all the instructions will be provided in writing with pictures and video recording to reinforce the demonstrations conducted during the training provided for each activity. Activities will be incorporated into their daily routines e.g. day care and home programs. Activities will be practiced everyday whenever possible. A timeline will be set for each activity and reassessment will be performed accordingly. After mastering the skill new skill level (to make it more challenging) and activity intervention will be selected. Parents will keep a record of the intervention they are doing at home in the form of a diary card. Standard care - The current standard care practice is a therapy program built on the principles of motor learning but delivered via demonstration and oral instructions only. Further there is no systematic program design; it is based on individual skill level of the child. Weekly appointments will be provided. (one face to face session followed by two tele-health sessions )Thirty minute sessions will be held at the physiotherapy area. The usual equipment and the toys in the physiotherapy room will be used for the session. Qualified Physiotherapist will assess the child and activities will be introduced according to the assessment findings. All the activities will be explained orally and demonstrated. The families are trained to deliver these interventions at home whenever possible within the daily routines; there is no strict prescription of therapeutic interventions.
Blinding- Only the Assessor who does the assessments will be blinded.

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

  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

Primary outcome(s)


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 outcome(s)

  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.


Target number/sample size

40( 20 for each group)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment


Date of study completion

Recruitment status

Complete: follow up continuing

Funding source

self funded

Regulatory approvals


State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: Ethics review committee of Faculty of Medicine, University of Kelaniya
Institutional Address:Secretary, Ethics Review Committee Faculty of Medicine, University of Kelaniya, Ragama.
Email: ercmed@kln.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Thilini Madushika
Research Assistant
Department of Disability Studies , Faculty of Medicine, University of Kelaniya


Contact Person for Public Queries

Prof. Samanmali Sumanasena
Professor in Pediatric Disabilities
Department of Disability Studies , Faculty of Medicine, University of Kelaniya


Primary study sponsor/organization


Secondary study sponsor (If any)


Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not applicable

Study protocol available


Protocol version and date

version 1

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results