Synchronous vs. Asynchronous Telerehabilitation for High-Risk Infants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-9
SponsorBiruni University

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Synchronous Telerehabilitation Group
  • Asynchronous Telerehabilitation Group

Treatment groups

48 Participants
are divided into 3 treatment groups

Sponsors and collaborators