NCT07498101

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 23, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

cerebral palsyGross Motor FunctionEARLY MOTOR REPERTOIRE QUALITYLATER-TERM MOTOR FUNCTION

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 months

Study Arms (1)

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.

Eligibility Criteria

Age3 Months - 5 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Türkiye Spastik Çocuklar Vakfı

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • osman çoban, phD

    Uskudar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

December 1, 2023

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations