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

NCT07296003 | Recruiting

• 1 other identifier: 707/19.4.2024
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Keywords

General Movements Assessment; Motor Optimality Score Revised; Postural Control; Full-Term Infants; Preterm Infants; Neurodevelopmental Outcomes

Outcome Measures

Primary Outcomes (1)

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

  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.

  april 2024 - july 2027

Secondary Outcomes (1)

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

  april 2024 - july 2027

Other Outcomes (2)

• Predictive Validity of MOS-R in Preterm vs. Full-Term Cohorts

  april 2024 - july 2027

• Developmental Outcomes in Infants With Atypical Early Movement Quality Who Did or Did Not Receive Early Therapy

  april 2024 - july 2027

Study Arms (2)

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.

Other: Vojta method

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.

Other: Vojta method

Interventions

Vojta method 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; Preterm Infants Cohort

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants in this study are infants who were seen for routine clinical follow-up in the Neonatal Unit and the physiotherapy outpatient clinic at Pardubice Regional Hospital and cooperating rehabilitation centers. During their early visits, these infants had video recordings made of their spontaneous movements as part of standard clinical care. Both preterm and full-term infants are included. When the children reach approximately 18-36 months of age, their parents or legal guardians are invited to complete a developmental questionnaire as part of the study's follow-up.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masaryk University: lead

Study Sites (3)

Nemocnice Pardubického kraje, a.s.

Pardubice, Czechia, 53002, Czechia

RECRUITING

Lentilka - integrated kindergarden and rehabilitation center

Pardubice, Česká Republika, 530 02, Czechia

RECRUITING

Lentilka - integrated kindergarden and rehabilitation center

Pardubice, Česká Republika, 530 02, Czechia

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders; Motor Skills Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Lukas Teply, Master degree

CONTACT

+420776845807; l.teply@seznam.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: April 19, 2024
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3)