Cerebral PalsyNCT07498101
The Relationship Between Early Motor Repertoire Quality and Later-term Motor Function in Children With CP
An observational study of Cerebral Palsy, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is a group of disorders attributed to non-progressive disorders occurring in the developing fetal, infantile brain, affecting posture, movement development, and activity limitations. It occurs in approximately 2 to 2.5 per 1,000 live births. Read more about this study
- Who is it for?
- Ages 3 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children diagnosed with Cerebral Palsy who applied to the Turkish Spastic Children Foundation for evaluation between 2011 and 2023 and whose Prechtl Analysis shots were archived between the 10th and 20th weeks will be included in the study.
Who may be able to join
- Children with a diagnosis of Cerebral Palsy
- Children who applied to the Turkish Spastic Children Foundation between 2011-2023
- Availability of Prechtl General Movements Assessment recordings obtained between 10-20 weeks post-term age
- Availability of GMFM-66 assessment data
Who cannot join
- Lack of parental or legal guardian consent
- Presence of additional diagnoses affecting motor assessment
- Cases where GMFM-66 evaluation was not applicable
- Incomplete clinical records
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Türkiye Spastik Çocuklar Vakfı
Istanbul, Ataşehir, 34750
About this study
Cerebral palsy (CP) is a group of disorders attributed to non-progressive disorders occurring in the developing fetal, infantile brain, affecting posture, movement development, and activity limitations. It occurs in approximately 2 to 2.5 per 1,000 live births. The prognosis for gross motor function among children with CP is extremely variable. This variability poses a significant challenge to scientific definitions of motor function for clinicians who regularly deal with practical issues such as examination, prognosis, intervention planning, and outcome assessment in children with CP. Observing the general quality of movement of preterm or term babies can be used to identify babies at risk of developing neurological disorders and can provide information about possible future motor function.
Read the detailed description
They frequently use the 66-item Gross Motor Function Measurement (GMFM-66) to evaluate gross functions and the Gross Motor Function Classification System (GMFCS) to classify gross motor functions. It is important to use the data obtained from these methods to assist in examination, prognosis, intervention planning and outcome evaluation for children with CP. In addition, the Motor Optimality Score (MOS), which is based on observing the quantity and quality of movement patterns, is used. When we look at the literature, there are very few studies comparing the amount and quality of the motor repertoire obtained using the early motor optimality score with the motor functions in the later period. Therefore, in this study, in addition to evaluating general movements in early infancy (3-5 months), it is aimed to predict the motor function in the future by evaluating the quality and amount of motor repertoire (motor optimality score, MOS) (movement and posture of the baby).
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, Gross Motor Function, EARLY MOTOR REPERTOIRE QUALITY, LATER-TERM MOTOR FUNCTION
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Babies aged between 3 months and 5 months (corrected age) who applied to the Turkish Spastic Children Foundation for risky baby evaluation between 2011 and 2023, whose videos were recorded for GM's evaluation, and who were later diagnosed with cerebral palsy will be included in the study. The quality of the early engine repertoire will be evaluated with MOS (Motor Optimality Score) based on GM's video footage. The evaluation will be carried out by a physiotherapist who has received advanced GM's evaluation training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Optimality Score (MOS)
Motor optimality score (MOS) have 5 categories to the score. These are fidgety movements (max 12 points), repertoire of co-existent other movements (max 4 points), quality of other movements (max 4 points), posture (max 4 points) and movement character (max 4 points). The category scores are added to a max of 28 points.
Measured: 3 months
Gross Motor Function Measurement (GMFM-66)
The Gross Motor Function Measure (GMFM) is a tool that has been developed to assess change in gross motor function in children with cerebral palsy aged 5 months to 16 years of age.1 The GMFM measures 'activity' as defined within the Interna- tional Classification of Functioning, Disability and Health.2 To administer the GMFM, a trained therapist observes the child completing a number of gross motor tasks in a standardised environment, and the child's best ability is measured.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Dec 2023
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osman coban, Uskudar University
- Investigators
- osman çoban, phD, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498101
- Sponsor's protocol ID
- Uskudaraysesav
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After we complete the study, results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Early Motor Repertoire Quality and Later-term Motor Function in Children With CP
- ClinicalTrials.gov ID
- NCT07498101
- Acronym / sponsor ID
- Uskudaraysesav
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, Gross Motor Function, EARLY MOTOR REPERTOIRE QUALITY, LATER-TERM MOTOR FUNCTION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 27 Mar 2026 (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.
Cerebral palsy (CP) is a group of disorders attributed to non-progressive disorders occurring in the developing fetal, infantile brain, affecting posture, movement development, and activity limitations. It occurs in approximately 2 to 2.5 per 1,000 live births. The prognosis for gross motor function among children with CP is extremely variable. This variability poses a significant challenge to scientific definitions of motor function for clinicians who regularly deal with practical issues such as examination, prognosis, intervention planning, and outcome assessment in children with CP. Observing the general quality of movement of preterm or term babies can be used to identify babies at risk of developing neurological disorders and can provide information about possible future motor function.
Detailed description
They frequently use the 66-item Gross Motor Function Measurement (GMFM-66) to evaluate gross functions and the Gross Motor Function Classification System (GMFCS) to classify gross motor functions. It is important to use the data obtained from these methods to assist in examination, prognosis, intervention planning and outcome evaluation for children with CP. In addition, the Motor Optimality Score (MOS), which is based on observing the quantity and quality of movement patterns, is used. When we look at the literature, there are very few studies comparing the amount and quality of the motor repertoire obtained using the early motor optimality score with the motor functions in the later period. Therefore, in this study, in addition to evaluating general movements in early infancy (3-5 months), it is aimed to predict the motor function in the future by evaluating the quality and amount of motor repertoire (motor optimality score, MOS) (movement and posture of the baby).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Babies aged between 3 months and 5 months (corrected age) who applied to the Turkish Spastic Children Foundation for risky baby evaluation between 2011 and 2023, whose videos were recorded for GM's evaluation, and who were later diagnosed with cerebral palsy will be included in the study. The quality of the early engine repertoire will be evaluated with MOS (Motor Optimality Score) based on GM's video footage. The evaluation will be carried out by a physiotherapist who has received advanced GM's evaluation training. |
Who may qualify
- Ages
- 3 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children diagnosed with Cerebral Palsy who applied to the Turkish Spastic Children Foundation for evaluation between 2011 and 2023 and whose Prechtl Analysis shots were archived between the 10th and 20th weeks will be included in the study.
Key inclusion criteria (4 listed)
- Children with a diagnosis of Cerebral Palsy
- Children who applied to the Turkish Spastic Children Foundation between 2011-2023
- Availability of Prechtl General Movements Assessment recordings obtained between 10-20 weeks post-term age
- Availability of GMFM-66 assessment data
Key exclusion criteria (4 listed)
- Lack of parental or legal guardian consent
- Presence of additional diagnoses affecting motor assessment
- Cases where GMFM-66 evaluation was not applicable
- Incomplete clinical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motor Optimality Score (MOS)
Time frame: 3 months
Motor optimality score (MOS) have 5 categories to the score. These are fidgety movements (max 12 points), repertoire of co-existent other movements (max 4 points), quality of other movements (max 4 points), posture (max 4 points) and movement character (max 4 points). The category scores are added to a max of 28 points.
Gross Motor Function Measurement (GMFM-66)
Time frame: 3 months
The Gross Motor Function Measure (GMFM) is a tool that has been developed to assess change in gross motor function in children with cerebral palsy aged 5 months to 16 years of age.1 The GMFM measures 'activity' as defined within the Interna- tional Classification of Functioning, Disability and Health.2 To administer the GMFM, a trained therapist observes the child completing a number of gross motor tasks in a standardised environment, and the child's best ability is measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided. After we complete the study, results will be shared
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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. This study is not recruiting at the moment.
osman çoban, phD principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Uskudar University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Optimality Score (MOS) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 30 Mar 2026.