Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months

Официальное название

A Longitudinal Observational Study of Early Spontaneous Motor Activity, Postural Control, and Motor Optimality Score (MOS-R) as Predictors of Psychomotor, Cognitive, and Sensory Development at 18 and 36 Months in Preterm and Term Infants, With Consideration of Early Therapeutic Intervention

Обзор

This study examines how early motor behavior in infants relates to their later psychomotor development. Researchers will observe both preterm and full-term infants during the first months of life, using video-based assessments to evaluate spontaneous movements and early postural control. These early motor patterns will be scored with the Motor Optimality Score - Revised (MOS-R). When the children reach 18 and 36 months of age, their development in areas such as motor skills, communication, sensory processing, and social behavior will be evaluated through a caregiver-completed questionnaire. The purpose of the study is to determine whether early motor quality can predict later developmental outcomes, whether preterm and full-term infants with similar motor scores develop differently, and whether early therapy may improve outcomes for infants with low MOS-R results.

Подробное описание

This study uses a combined retrospective-prospective observational design. The retrospective component includes previously recorded video assessments of spontaneous motor behavior and postural control collected during routine clinical examinations in both preterm infants and a comparison group of full-term infants. These recordings were originally obtained as part of standard care in the neonatal unit and physiotherapy outpatient clinic and were subsequently anonymized for research purposes. Early motor quality was evaluated using standardized scoring procedures, including the Motor Optimality Score - Revised (MOS-R) and detailed general movement assessment.

The prospective component is used to complete developmental follow-up. Caregivers are contacted when the child reaches 18 and 36 months of age and are asked to complete a validated questionnaire assessing domains such as motor development, communication, sensory processing, and socio-emotional functioning. By integrating retrospective motor assessments with prospective developmental outcomes, the study enables a rigorous analysis of the predictive relationship between early motor patterns and later psychomotor development.

A combined design is necessary because high-quality video recordings of early motor behavior cannot be reproduced once the infant has aged, and the early spontaneous movement repertoire represents a unique neurodevelopmental window. The retrospective use of existing recordings reduces participant burden and allows comparison between preterm infants and full-term infants who underwent the same standardized motor assessment. The prospective follow-up ensures that developmental outcomes are measured consistently and with sufficient temporal precision. Overall, this design increases feasibility, minimizes risk, and provides a robust framework for evaluating early markers of developmental trajectories.

Вмешательства

• Другое Vojta method
  Vojta method, also known as reflex locomotion, was offered to infants who demonstrated atypical or reduced quality of early spontaneous motor behavior during clinical evaluation. The method uses specific pressure stimulation zones to activate innate locomotor patterns aimed at improving postural control, axial stability, and motor coordination. In this study, Vojta therapy was not assigned by the research protocol but initiated by caregivers following clinical recommendation. Therefore, exposure

Первичные конечные точки

• Association Between the Quality of Early Spontaneous Movements and Developmental Outcomes at 18 and at 36 months [Срок оценки: april 2024 - july 2027]

Вторичные конечные точки (1)

• Correlation Between MOS-R and Specific Developmental Sub-Domains (Motor vs. Non-Motor) [Срок оценки: april 2024 - july 2027]

Критерии участия

Критерии включения

• The child was born either preterm or full-term. Both groups are included in the study.
• The child completed a video recording of early movements during routine check-ups in the first months of life.
• The parents or legal guardians agree to participate and give informed consent.
• The child will be available for follow-up at around 18-36 months of age, when parents will complete a developmental questionnaire.

Критерии исключения

• There is no usable video recording of the child's early spontaneous movements from the neonatal or early infant period.
• The child has a diagnosed medical condition that makes movement assessment impossible (for example, severe congenital anomalies or conditions preventing typical movement).
• Parents do not wish to participate or withdraw their consent.
• The child is not available for follow-up, meaning that the developmental questionnaire at 18-36 months cannot be completed.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Чехия · 3 центра

• Nemocnice Pardubického kraje, a.s. — Pardubice
• Lentilka - integrated kindergarden and rehabilitation center — Pardubice
• Lentilka - integrated kindergarden and rehabilitation center — Pardubice

Идентификаторы

NCT: NCT07296003 · 707/19.4.2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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