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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04886310
Other study ID # 41901325-050.99
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2020
Est. completion date July 1, 2021

Study information

Verified date April 2023
Source Ondokuz Mayis University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is the determination of the Turkish version of the Peabody Developmental Motor Scale-2 and its Turkish validity reliability in infants age between 0 - 24 months and to spread its use for evaluation in early rehabilitation in our country.


Description:

There are developments in the field of diagnosing children with a high risk of developmental disorders such as cerebral palsy (CP), mental problems and autism spectrum disorder in infancy . In particular, in infants experiencing the onset of extrauterine life in the neonatal intensive care unit, the combination of neonatal neuroimaging along with the assessment of general movements results in a highly accurate prediction of CP .A clinical tool often used in predictions is a neurological examination. Various standard variants are available, such as the Hammersmith Infant Neurological Examination (HINE), Alberta Infant Motor Scale (AIMS). PGMS-2 was developed by Folio and Fewell (2000) to determine the gross and fine motor development levels of children from birth to 71 months. The scale can be used for both children with healthy development and children with special needs. In the development of the Peabody Developmental Motor Scale (PGMS), which is the original version of PGMS-2 used in this study, a developmental structure was adopted instead of sticking to a certain theoretical perspective. PGMS is the first nationally standardized assessment tool that gives gross and fine motor scores separately in the United States of America (USA).This study is the determination of the Turkish version of the Peabody Developmental Motor Scale-2 and its Turkish validity reliability in infants age between 0 - 24 months and to spread its use for evaluation in early rehabilitation in our country.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Month to 24 Months
Eligibility Inclusion Criteria: - Infants between 0-24 months (adjusted age for premature infants will be calculated),who are followed as neurologically and developmentally at risk infants - Infants who are not in neonatal intensive care unit Exclusion Criteria: - Infants with congenital heart problems - Infants of families who do not accept the study - Infants with musculoskeletal system anomaly - Infants connected to respiratory equipment

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Peabody Developmental Motor Scale II (PDMS-2)
is composed of six subtests (reflex, stationary, locomotion, object manipulation, grasping, and visual-motor integration) that measure inter-related abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through 5 years of age.

Locations

Country Name City State
Turkey Nilay Çömük Balci Samsun Atakum

Sponsors (1)

Lead Sponsor Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peabody Developmental Motor Scale II (PDMS-2) is composed of six subtests (reflex, stationary, locomotion, object manipulation, grasping, and visual-motor integration) that measure inter-related abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through 5 years of age. 45-60 minutes
Secondary The Alberta Infant Motor Scale (AIMS) The AIMS is a norm-referenced observational scale that enables the determination of infants with delay or deviation in motor development and to evaluate the changes in motor development over time. It is used to follow the movement patterns of infants who show atypical movement patterns over time. Average application time is 30-40 minutes. 0-18. The evaluation is made on a total of 58 items in 4 different developmental positions: supine, prone, sitting and standing between months. 30-40 minutes
Secondary Hammersmith Infant Neurological Examination (HINE) The HINE includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour. The first section evaluates cranial nerve, posture, movements, tone and reflexes. These items are not age-dependent. The second section evaluates head control, sitting, voluntary grasping, rolling, crawling and walking. The third section evaluates state of consciousness, emotional state and social orientation. 30-45 minutes
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