Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06015347 |
| Other study ID # |
MU-FTR-OK-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
August 2023 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
