Not Yet RecruitingNot Applicable

Synchronous vs. Asynchronous Telerehabilitation for High-Risk Infants

Turkey (Türkiye)48 participantsStarted 2026-05-04

Plain-language summary

Premature birth, low birth weight, and a history of neonatal intensive care history are significant risk factors associated with long-term neurodevelopmental adverse outcomes in infants. Family-centered early intervention programs play a critical role in minimizing the impact of these risks and optimizing developmental potential. Currently, telerehabilitation (TR) has emerged as a cost-effective solution that facilitates access to early intervention services. However, there is limited literature directly comparing the efficacy and feasibility of synchronous (real-time) and asynchronous (store-and-forward) parent coaching-based TR models specifically within the at-risk infant population. The primary objective of this project is to comparatively examine the effects of synchronous and asynchronous TR programs on motor development levels, individualized goal attainment, and parental self-efficacy in infants aged 6-9 months (corrected age) at risk of developmental delay, against a standard home program (control group). Designed as a randomized controlled trial, the study will include 45 high-risk infants meeting the inclusion criteria, who will be randomly allocated into three groups: Synchronous TR, Asynchronous TR, and Control. In the Synchronous group, parents will receive real-time coaching via video conferencing for 12 weeks, whereas the Asynchronous group process will be managed through video analysis and delayed feedback mechanisms. The Control group will be provided with standard digital educational materials. The primary outcome measures of the study include Goal Attainment Scaling (GAS) scores, the Parental Self-Efficacy Instrument, and the Parenting Stress Index. Secondary measures will include the Bayley Scales of Infant and Toddler Development (Bayley-IV), the Alberta Infant Motor Scale (AIMS), and the Hammersmith Infant Neurological Examination (HINE). Data will be collected at baseline (T0) and post-intervention (T1) by an assessor blinded to group allocation. The findings obtained from this study aim to demonstrate the clinical efficacy of different TR models, thereby providing guidance for the planning and dissemination of remote healthcare services for high-risk infants.

Who can participate

Age range

6 Months – 9 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Gestational age ≤32 weeks and/or birth weight ≤1500 grams. * Corrected age between 6 and 9 months at the time of enrollment. * Referral to a pediatric neurology clinic and/or current follow-up by a pediatric neurologist due to developmental risk. * A total score of ≤73 on the Hammersmith Infant Neurological Examination (HINE) (Romeo et al., 2021; Novak et al., 2017). * A score ≤5th percentile on the Alberta Infant Motor Scale (AIMS) (Fuentefria et al., 2017). * Parental willingness to participate and signing of the "Informed Consent Form." * Access to the minimum technological infrastructure required for telerehabilitation (smartphone, tablet, or computer with video calling capability and active internet access). Exclusion Criteria: * Presence of diagnosed genetic syndromes or metabolic diseases known to directly affect neuro-motor development. * Major congenital malformations causing significant movement restriction or exercise intolerance. * History of symptomatic hypoglycemia associated with severe brain injury during the neonatal period. * Sensory impairments (bilateral blindness or severe bilateral hearing loss not correctable with hearing aids) that prevent participation in assessments and exercises based on visual and auditory stimuli. * Acute or unstable clinical conditions that preclude the safe conduct of the intervention (e.g., continuous mechanical ventilation, hemodynamic instability, uncontrolled seizures, or active acute infections). * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compares two types of telerehabilitation — one where we interact with a therapist in real time and one where we work through recorded or delayed content — how do these two approaches actually differ in practice, and which might fit better with our family's schedule and internet access?
2Since this study is focused on goals we set ourselves using something called Goal Attainment Scaling, as well as our stress and confidence as parents, does it address our baby's specific motor delays directly, or is it more about supporting us as caregivers?
3The trial isn't recruiting yet — given our baby's age and how quickly early development moves, is this something worth waiting for, or should we be starting a standard early intervention program now so we don't lose time?
4Because this is listed as Phase NA, meaning it's comparing two care delivery methods rather than testing a new treatment, what is the realistic risk involved, and is there any reason to think one format might be less effective for a baby with our child's particular risk factors?
5Are there already established telehealth or in-person early intervention services available to us right now that we should be pursuing, and how would participating in this study fit alongside or instead of those options?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Goal Attainment Scaling

Timeframe: Baseline and after 12 weeks

Parental Self-Efficacy Instrument for Children with Disabilities

Timeframe: Baseline and after 12 weeks

Parenting Stress Index - Short Form (PSI-SF)

Timeframe: Baseline and after 12 weeks

Trial details

NCT IDNCT07499843

SponsorBiruni University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-04

Contact for this trial

GÜLSENA UTKU UMUT, PhD

+905370664646 gulsenautkuumut@gmail.com

View on ClinicalTrials.gov More Risky Baby trials

Plain-language summary

Who can participate

Age range

6 Months – 9 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.