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

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SLCTR Registration Number

SLCTR/2020/014


Date of Registration

18 May 2020

The date of last modification

Jun 05, 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

Neurodevelopment


Scientific Acronym

None


Public Acronym

None


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

U1111-1228-2685


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

P/228/12/2018


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

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)

1.

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)

1.

• 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)

]
2.

• 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

2020-09-01


Anticipated end date

2021-07-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self funded


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2018-12-11


Approval number

P/228/12/2018


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
0772007952
0772007952

dilvip777@yahoo.com

Contact Person for Public Queries

Samanmali P. Sumanasena
Professor and Consultant Paediatrician
Department of Disability Studies, Faculty of Medical Sciences, University of Kelaniya
0112958251
0777256768

samanmali@kln.ac.lk


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)?

Yes


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

Yes


Protocol version and date

version 1.0 dated 06/02/2019



Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results