Neurodevelopmental DisordersNCT07296003
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
An observational study of Neurodevelopmental Disorders and Motor Skills Disorders, run by Masaryk University at 3 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Motor Skills Disorders, Infant, Premature Development
- What is being tested?
- Vojta method
- How many people
- 60 participants
- Where
- 3 sitesCzechia
- Study dates
- 19 Apr 2024to 1 Jan 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia3 sites, 3 recruiting
- Recruiting
Nemocnice Pardubického kraje, a.s.
Pardubice, Czechia, 53002
Marian Šenkeřík, MD, +420466015404, marian.senkerik@nempk.cz
- Recruiting
Lentilka - integrated kindergarden and rehabilitation center
Pardubice, Česká Republika, 530 02
Lukas Teply, Master degree, +420776845807, l.teply@seznam.cz
- Recruiting
Lentilka - integrated kindergarden and rehabilitation center
Pardubice, Česká Republika, 530 02
Gabriela Belkova, Master degree, 733724538, belkova@lentilka.eu
About this study
Official title: 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
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.
Read the detailed description
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
- Neurodevelopmental Disorders, Motor Skills Disorders, Infant, Premature Development, Infant, Term Development, Postural Balance
- Being tested
- Vojta method
- Keywords
- General Movements Assessment, Motor Optimality Score Revised, Postural Control, Full-Term Infants, Preterm Infants, Neurodevelopmental Outcomes
- Medical subject headings
- Neurodevelopmental Disorders, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta methodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Vojta method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: april 2024 - july 2027
Secondary outcomes (1)
Correlation Between MOS-R and Specific Developmental Sub-Domains (Motor vs. Non-Motor)
Assessment of the relationship between early MOS-R scores and specific sub-scales of the caregiver questionnaire at both 18 and 36 months. The analysis will distinguish between Gross/Fine Motor scores versus Communication and Social-Emotional scores. The aim is to evaluate whether early motor optimality is a stronger predictor of later motor skills compared to cognitive/language skills.
Measured: april 2024 - july 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start19 Apr 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296003
- Sponsor's protocol ID
- 707/19.4.2024
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07296003
- Acronym / sponsor ID
- 707/19.4.2024
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm Infants Cohort | – | Other: Vojta methodInfants 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. |
| Full-Term Infants | – | Other: Vojta methodInfants 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. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vojta methodVojta 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. | Other | Full-Term Infants, Preterm Infants Cohort |
Primary outcome
Association Between the Quality of Early Spontaneous Movements and Developmental Outcomes at 18 and at 36 months
Time frame: 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.
1 secondary outcome
Correlation Between MOS-R and Specific Developmental Sub-Domains (Motor vs. Non-Motor)
Time frame: april 2024 - july 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Neurodevelopmental Disorders
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders and Motor Skills Disorders, run by Masaryk University at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Teply, Master degree (+420776845807, l.teply@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between the Quality of Early Spontaneous Movements and Developmental Outcomes at 18 and at 36 months (time frame: april 2024 - july 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.