Home » Trials » SLCTR/2020/014

Short term functional motor outcomes during high risk infant follow up from a single hospital receiving interventions through telerehabilitation; a randomised control clinical trial


SLCTR Registration Number


Date of Registration

18 May 2020

The date of last modification

Sep 10, 2020

Application Summary

Scientific Title of Trial

Short term functional motor outcomes during high risk infant follow up from a single hospital receiving interventions through telerehabilitation; a randomised control clinical trial

Public Title of Trial

Effectiveness of tele-rehabilitation compared to conventional face to face follow up on short term motor function in infants having risk factors for adverse neurodevelopmental outcome in a single centre: a randomized control trial.

Disease or Health Condition(s) Studied


Scientific Acronym


Public Acronym


Brief title

Effect on motor functions through telerehabilitation compared to conventional face to face clinic follow up, on high risk infant follow up program delivering early interventions.

Universal Trial Number


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


Trial Details

What is the research question being addressed?

Is telerehabilitation effective as an early intervention for functional motor outcome compared to conventional clinic follow-up in infants having risk factors for adverse neurodevelopmental outcome?

Type of study


Study design


Randomized controlled trial


Single blinded : Outcome assessors


Standard therapy/practice




Supportive care

Study Phase

Not Applicable

Intervention(s) planned

Study setting Colombo North Teaching Hospital (CNTH) and multidisciplinary clinic at Department of Disability Studies, Ragama.

Randomization The children will be randomized to 3 groups (3 arms - 2 intervention, 1- control ) using blocked randomization method to ensure equal sample sizes in each group. Block size will vary during randomization to minimize bias.Allocation sequence will be generated using computer program. Allocation sequence will be implemented using serially numbered sealed opaque envelops. Each envelop will consist of the name of the arm allocated for a particular child.

Intervention All the neonates with major antenatal and perinatal risk factors will be selected from two neonatal units- postnatal wards, special care baby units and neonatal intensive care units in CNTH with the assistance from neonatology teams using a checklist. Infants with risk factors and positive general movement assessment during the writhing period will be enrolled in to Risk Infant Follow-up (HRIF) program at the neonatal units.

Intervention group (Group 1 and 2) Infants who will follow up through real time video conference based interactive follow up program. Video conferencing will be done through a freely downloadable mobile application. Following initial randomization, the parents will be given a training on a) familiarization and working with the mobile application, b) suitable angles to hold the mobile phone/tab for assessment by multidisciplinary team during conference call. Each session will have a pediatrician, physical therapist, occupational therapist and speech and language therapist in the conference call. Each session will last 30- 45 minutes. Child will be observed in the home setting and parent-child interactions, play and direct communications will be used to assess the progress. Then each therapist will explain their plan and new interventions through the conversations and demonstrations.

Frequency of sessions will be once in every 4 weeks follow up for group 1 and once every 2 weeks for treatment group 2.

Control Group Includes infants in conventional follow up program. Conventional follow up consists of variable one to one, single or combined therapy sessions by a pediatrician, physical therapist, occupational therapist and speech and language therapist. Each session may vary between 10- 30 minutes. Duration and involvement of each session will be documented for future reference. The clinician or therapist involved usually decides frequency depending on child’s abilities and availability of appointments. In the study, the frequency of sessions will be according to waiting list and available appointments of each therapist/ clinician. According to an audit done in current developmental surveillance program the frequency of intervention sessions varied between 4- 6 weeks. Different teams would be involved in interventions for the control group. However, intervention group 1 and 2 will have the same team.

Inclusion criteria

• Babies born at Colombo North Teaching Hospital • Having one or more risk factors for adverse neurodevelopmental outcome: Prematurity (<37/52), placental abnormalities (maternal DM, HT), low birthweight (<2500g), birth asphyxia/ hypoxic ischaemic encephalopathy, neonatal jaundice, neonatal seizures, respiratory distress syndrome, hypoglycaemia and neonatal infection. • Having abnormal writhing general movement assessment as concluded by two of the three assessors.cramped synchronized, poor repertoire or chaotic movements, in the two video assessments at two consecutive time points two weeks apart. • infants must live in the study geographical areas to facilitate follow up • Families agreeing to take part for the full study period of 6 months (with the provision to withdraw as per the informed consent sheet)

Exclusion criteria

• Infants who have major structural abnormality in other body system. Eg: Cardiac anomaly, which may interfere with motor functions • Genetic syndrome or metabolic syndrome which usually has impact on neurodevelopmental outcome • Subjects who have difficulty complying with the intervention (unavailability of a smart phone which is compatible with videoconferencing) • Inconclusive general movement assessment • Subjects who do not consent for the research

Primary outcome(s)


Mean scores of the GMFM-66. The Gross Motor Function Measure (GMFM-66) is a standardised criterion referenced measurement tools designed to measure gross motor function over time for children with disabilities.


Baseline (T0), Post intervention 3 months (T1), Post intervention 6 months (T2)


Secondary outcome(s)


• Mean scores of the Canadian Occupational Performance measure(COPM) performance and satisfactory score. This measures the parent perceived change in their infants’ performance of prioritized goals and level of their satisfaction with progress.


Baseline (T0), Post intervention 3 months (T1), Post intervention 6 months (T2)


• Cost analysis using WHO CostIt software CostIt will be used to calculate the economic costs of interventions.


Post intervention 6 months (T2)


Target number/sample size

75 (25 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

Self funded

Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: ERC, Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 06, Thalagolla Road, Ragama
Telephone:0094112961267, 0094112961000
Email: ercmed@kln.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dilini Vidyathilaka Vipulaguna
Senior Registrar, Community Paediatrics
Post graduate institute of medicine, 160, Prof. Nandadasa Kodagoda Rd, Colombo


Contact Person for Public Queries

Samanmali P. Sumanasena
Professor and Consultant Paediatrician
Department of Disability Studies, Faculty of Medical Sciences, 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

All individual data underlie the results of publication of the trial (texts, tables, appendices) will be shared. Also study protocol and statistical analysis plan will be available. Data will be available immediately after publication without end date. Data available for meta-analysis for researches whose proposals approved by independent review committee through a link provided by principal investigator via dilvip777@yahoo.com.

Study protocol available


Protocol version and date

version 1.0 dated 06/02/2019

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