Synchronous vs. Asynchronous Telerehabilitation for High-Risk Infants

Официальное название

Family-Centered Early Intervention Program Under Physiotherapist Coaching for High-Risk Infants: A Comparison of Synchronous and Asynchronous Telerehabilitation Models

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• Goal Attainment Scaling [Срок оценки: Baseline and after 12 weeks]
• Parental Self-Efficacy Instrument for Children with Disabilities [Срок оценки: Baseline and after 12 weeks]
• Parenting Stress Index - Short Form (PSI-SF) [Срок оценки: Baseline and after 12 weeks]

Вторичные конечные точки (5)

• Hammersmith Infant Neurological Examination [Срок оценки: Baseline and after 12 weeks]
• Bayley Scales of Infant and Toddler Development, Fourth Edition [Срок оценки: Baseline and after 12 weeks]
• Alberta Infant Motor Scale [Срок оценки: Baseline and after 12 weeks]
• Telehealth Usability Questionnaire [Срок оценки: Baseline and after 12 weeks]
• Telemedicine Satisfaction Questionnaire [Срок оценки: Baseline and after 12 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Biruni University Department of Physiotherapy and Rehabilitation — Istanbul

Идентификаторы

NCT: NCT07499843 · 1002-EI-ASYN-VS-SYN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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