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

NCT ID: NCT07296003

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-19

Study Completion Date

2027-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neurodevelopmental Disorders Motor Skills Disorders Infant, Premature Development Infant, Term Development Postural Balance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Vojta method

Intervention Type OTHER

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 to Vojta method represents a naturally occurring, non-randomized behavioral intervention and is analyzed only for exploratory purposes.

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.

Vojta method

Intervention Type OTHER

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 to Vojta method represents a naturally occurring, non-randomized behavioral intervention and is analyzed only for exploratory purposes.

Interventions

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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 to Vojta method represents a naturally occurring, non-randomized behavioral intervention and is analyzed only for exploratory purposes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Masaryk University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nemocnice Pardubického kraje, a.s.

Pardubice, Czechia, Czechia

Site Status RECRUITING

Lentilka - integrated kindergarden and rehabilitation center

Pardubice, Česká Republika, Czechia

Site Status RECRUITING

Lentilka - integrated kindergarden and rehabilitation center

Pardubice, Česká Republika, Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Lukas Teply, Master degree

Role: CONTACT

+420776845807

Facility Contacts

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Marian Šenkeřík, MD

Role: primary

+420466015404

Lukas Teply, Master degree

Role: primary

+420776845807

Gabriela Belkova, Master degree

Role: primary

733724538

Other Identifiers

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707/19.4.2024

Identifier Type: -

Identifier Source: org_study_id

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