Synchronous vs. Asynchronous Telerehabilitation for High-Risk Infants
NCT07499843 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-03-30
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.
Conditions
- Risky Baby
- Premature Birth of Newborn
- Motor Delay
Interventions
- OTHER
-
Synchronous Telerehabilitation Group
A 12-week remote physiotherapy program based on a 'parent coaching' model delivered via real-time video conferencing (Zoom). The intervention consists of weekly 45-minute sessions where the physiotherapist acts as a coach, providing live verbal and visual guidance to parents as the primary implementers of the intervention. Activities are integrated into the infant's natural daily routines (play, feeding, care). Pre-session standardized guidance (camera positioning, infant readiness) is provided via WhatsApp. Clinical progress is monitored through weekly evaluation and updating of Goal Attainment Scaling (GAS) objectives tailored to the infant's developmental needs.
- OTHER
-
Asynchronous Telerehabilitation Group
A 12-week remote physiotherapy program based on a parent coaching model using a delayed feedback principle. To ensure therapeutic intensity equivalent to synchronous sessions, parents record and submit 10-15 minutes of video clips weekly through secure, end-to-end encrypted messaging. These clips demonstrate intervention activities integrated into daily routines (play, feeding, care). The physiotherapist performs a detailed analysis of handling techniques and movement quality, providing feedback via recorded demonstration videos (using a model doll or the therapist) to correct or reinforce motor patterns. Each weekly cycle includes evaluating Goal Attainment Scaling (GAS) objectives and updating motor strategies based on the infant's current developmental needs.
Sponsors & Collaborators
-
Biruni University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 9 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-04
- Primary Completion
- 2027-05-04
- Completion
- 2027-07-04
Countries
- Turkey (Türkiye)
Study Locations
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