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?

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.

• 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)

• 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