- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04886310
Peabody Developmental Motor Scale-2 in 0 - 24 Months in Turkey
April 26, 2023 updated by: Nilay Comuk Balci, Ondokuz Mayıs University
Turkish Validity and Reliability Study of Peabody Developmental Motor Scale-2 in Infants Aged 0 - 24 Months
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
40
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
-
-
Atakum
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Samsun, Atakum, Turkey, 55139
- Nilay Çömük Balci
-
-
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
Ages Eligible for Study
3 years to 1 year (Child)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Infants between 0-24 months (adjusted age for premature infants will be calculated),who are followed as neurologically and developmentally at risk infants
Description
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 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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peabody Developmental Motor Scale II (PDMS-2)
Time Frame: 45-60 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Alberta Infant Motor Scale (AIMS)
Time Frame: 30-40 minutes
|
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
|
|
Hammersmith Infant Neurological Examination (HINE)
Time Frame: 30-45 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: NILAY ÇÖMÜK BALCI, Pt,PhD, Ondokuz Mayıs 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)
September 10, 2020
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
May 10, 2021
First Submitted That Met QC Criteria
May 10, 2021
First Posted (Actual)
May 14, 2021
Study Record Updates
Last Update Posted (Actual)
April 27, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41901325-050.99
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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