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临床试验/NCT07296003
NCT07296003
招募中
不适用

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

Masaryk University4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月19日最近更新:
干预措施Vojta method

概览

阶段
不适用
状态
招募中
入组人数
60
试验地点
4
主要终点
Association Between the Quality of Early Spontaneous Movements and Developmental Outcomes at 18 and at 36 months

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
— 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Preterm Infants Cohort

Infants born moderately or late preterm (32-36 weeks gestation) who completed standardized video-based assessment of early spontaneous movements in infancy. Within this cohort, infants will be further stratified according to the quality of early spontaneous movements as evaluated by the Motor Optimality Score - Revised (MOS-R), distinguishing between typical movement quality and reduced or atypical movement quality. Among infants showing reduced or atypical movement quality, naturally occurring differences in early physiotherapy exposure will also be described. These characteristics serve as analytic stratification factors and do not define additional study groups.

干预措施: Vojta method (Other)

Full-Term Infants

Infants born at or after 37 weeks of gestation who completed the same standardized early assessment of spontaneous movements. As in the preterm cohort, infants will be stratified based on the quality of early spontaneous movements assessed using the Motor Optimality Score - Revised (MOS-R), distinguishing between typical and reduced or atypical movement quality. For infants with reduced/atypical movement quality, differences in early physiotherapy exposure may also be explored. These variables function as stratification factors for analysis and are not defined as separate study cohorts.

干预措施: Vojta method (Other)

结局指标

主要结局

Association Between the Quality of Early Spontaneous Movements and Developmental Outcomes at 18 and at 36 months

时间窗: april 2024 - july 2027

The quality of early spontaneous movements will be evaluated using standardized observational assessment in infancy. Developmental outcomes at 18 and 36 months will be compared between infants displaying typical movement quality and those showing reduced or atypical movement quality. This analysis aims to determine whether early differences in spontaneous motor behavior are associated with variations in later developmental functioning.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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