NCT06015347

Brief Summary

The primary purpose of this study is to evaluate the relationship between the developmental level between 1-18 months and gross motor performance in the preschool period in risky infants followed up from a center for early intervention, and to determine the risk of developmental coordination disorder in the preschool period in risky infants.Gross Motor Function Measurement-88 will be applied to children diagnosed with cerebral palsy in the pre-school period to evaluate motor performance, among risky infants evaluated by Alberta Infant Motor Scale between 1-18 months. Developmental Coordination Disorder Questionnaire will be applied to healthy children in order to evaluate the risk of gross motor performance and developmental coordination disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

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

June 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 23, 2023

Last Update Submit

August 23, 2023

Conditions

Keywords

Cerebral PalsyDevelopmental Coordination DisorderInfant, PrematureChild Development

Outcome Measures

Primary Outcomes (1)

  • Developmental Coordination Disorder Questionnaire

    Developmental Coordination Disorder Questionnaire is a 15-item questionnaire used to measure developmental coordination disorder risk and evaluate motor performance and skills in children aged 5-15 years. It consists of 15 items. Scoring is between 1 and 5 (1 = not similar, 5 = very similar). The maximum score that can be obtained from the test is 75. The range of scores indicating the risk of developmental coordination disorder varies according to age. 5-7 years - 15-46 points; 8-9 years - 15-55 points; It means that there is a risk of developmental coordination disorder between the ages of 10-15 - 15-57 points.

    4-6 years

Secondary Outcomes (1)

  • Gross Motor Function Measure-88

    4-6 years

Study Arms (1)

Assessment

Infants at risk rated with the Alberta Infant Motor Scale between 1-18 months

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

At-risk infants currently aged 4-6 years and evaluated with the Alberta Infant Motor Scale

You may qualify if:

  • To take part in the risky baby classification,
  • Being between the ages of 4-6,
  • To have been evaluated with the Alberta Infant Motor Scale at the Turkish Spastic Children Foundation Family Counseling Center,
  • To agree to participate in the study and to have the informed consent form approved by the family.

You may not qualify if:

  • The family does not approve the informed consent form,
  • Not being evaluated with the Alberta Infant Motor Scale,
  • Diagnosis of Down syndrome and genetic syndrome,
  • Being outside the age range,
  • Currently having a health problem that would prevent assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkish Spastic Children Foundation

Istanbul, Atasehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyMotor Skills DisordersPremature Birth

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ozge KARANLIK

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 29, 2023

Study Start

June 1, 2021

Primary Completion

August 15, 2021

Study Completion

November 30, 2021

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations