The Relationship Between Developmental Level in Infancy and Preschool Motor Performance in Risky Infants

August 23, 2023 updated by: Ozge Karanlik, Marmara University

The Relationship Between Motor Development Between 1-18 Months and the Risk of Developmental Coordination Disorder (DCD) in the Preschool Period and Cerebral Palsy (CP) in Risky Infants

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Risky infants are at risk in terms of development. Cerebral palsy, mental retardation, visual and hearing disorders are seen as major neurodevelopmental disorders, developmental coordination disorder, attention deficit and hyperactivity disorder and learning disability are seen as minor. In order to detect major and minor disorders that may be seen in the future, these infants should be evaluated periodically in terms of neurodevelopment from birth.There are many reliable tests in the neurodevelopmental evaluation of risky infants, and one of them is the Alberta Infant Motor Scale.

Alberta Infant Motor Scale (AIMS) assesses motor performance and level of development from birth to 18 months. AIMS finds a total of 58 items in 4 different positions, and each item is 1 point. The scores obtained in all positions are added together and this score is converted into a percentile score that shows the baby's status relative to his/her peers. When looking at the norm chart of AIMS, there are 5%, 10%, 25%, 50%, 75%, and 90% lines. The 5% and 10% norm lines are used as cutoff lines for abnormal motor development.

Gross Motor Function Measure-88 is used to evaluate gross motor performance and function change in children aged 15 months to 13 years with cerebral palsy and Down syndrome. There are a total of 88 items in 5 categories (supine and prone 17, sitting 20, crawling and kneeling 14, standing 13, walking, running, and climbing stairs 24). Scoring is done according to the ability to perform gross motor functions correctly. Scoring is done in the range of 0 - 3. If he/she starts the activity, 0 points, 1 point if he/she starts the activity, 2 points if he/she completes the activity partially, and 3 points if he/she completes the activity independently. Categories and total scores are calculated as a percentage (%).

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 DCD developmental coordination disorder between the ages of 10-15 - 15-57 points.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Atasehir
      • Istanbul, Atasehir, Turkey
        • Turkish Spastic Children Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Assessment
Infants at risk rated with the Alberta Infant Motor Scale between 1-18 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Developmental Coordination Disorder Questionnaire
Time Frame: 4-6 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measure-88
Time Frame: 4-6 years
Gross Motor Function Measure-88 is used to evaluate gross motor performance and function change in children aged 15 months to 13 years with cerebral palsy and Down syndrome. There are a total of 88 items in 5 categories (supine and prone 17, sitting 20, crawling and kneeling 14, standing 13, walking, running, and climbing stairs 24). Scoring is done according to the ability to perform gross motor functions correctly. Scoring is done in the range of 0 - 3. If he/she starts the activity, 0 points, 1 point if he/she starts the activity, 2 points if he/she completes the activity partially, and 3 points if he/she completes the activity independently. Categories and total scores are calculated as a percentage (%).
4-6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ozge KARANLIK, Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MU-FTR-OK-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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