Synchronous vs. Asynchronous Telerehabilitation for High-Risk Infants

Biruni University

Status: Not yet enrolling

Conditions: Premature Birth of Newborn; Risky Baby; Motor Delay

Treatments: Other: Synchronous Telerehabilitation Group; Other: Asynchronous Telerehabilitation Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07499843

1002-EI-ASYN-VS-SYN

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 6 to 9 months old

Volunteers: No Healthy Volunteers

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).
• Non-adherence to the study protocol, defined as missing more than 6 intervention sessions.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

48 participants in 3 patient groups

Synchronous Telerehabilitation Group

Other group

Description:

Participants in the synchronous group will receive a 12-week telerehabilitation program based on a 'parent coaching' model. The intervention consists of weekly 45-minute real-time video consultations via Zoom. To optimize session efficiency, parents receive standardized pre-session guidance (camera setup, infant readiness) via WhatsApp. The physiotherapist acts as a remote coach, providing live verbal and visual feedback to guide parents as the primary implementers during natural daily routines (play, feeding, care). Each session involves evaluating Goal Attainment Scaling (GAS) objectives from the previous week and collaborative development of new motor strategies and environmental modifications tailored to the infant's current developmental needs.

Treatment:

Other: Synchronous Telerehabilitation Group

Asynchronous Telerehabilitation Group

Other group

Description:

Participants in the asynchronous group will follow a 12-week telerehabilitation program based on a parent coaching model with a delayed feedback principle. To ensure therapeutic intensity equivalent to the synchronous sessions, parents will record and submit 10-15 minutes of video clips weekly, showing intervention activities integrated into daily routines (play, feeding, care). These videos are shared via secure, end-to-end encrypted messaging. The physiotherapist performs a detailed analysis of the parents' handling techniques and the infant's movement quality. Feedback is provided through 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.

Treatment:

Other: Asynchronous Telerehabilitation Group

Control Group

No Intervention group

Description:

Participants in the control group will follow a standard home-based program without active physiotherapist supervision or individualized coaching. At baseline (T0), infant-specific Goal Attainment Scaling (GAS) parameters are established. Families receive comprehensive standardized educational materials, including a 'Parent Education Booklet' (PDF) and instructional videos demonstrating motor activities and positioning. Throughout the 12-week period, families implement these strategies independently. Unlike the experimental groups, no live feedback, video analysis, or weekly goal revisions are provided; GAS goals remain fixed and are evaluated only at the 12th week (T1). For ethical monitoring, brief phone calls are conducted at weeks 4 and 8 to assess study adherence and general health, strictly excluding any therapeutic guidance or intervention updates.