Motor DevelopmentNCT04886310
Peabody Developmental Motor Scale-2 in 0 - 24 Months in Turkey
An observational study of Motor Development and Infant, Premature, Diseases, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Motor Development, Infant, Premature, Diseases
- What is being tested?
- Peabody Developmental Motor Scale II (PDMS-2)
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2020to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- Infants with congenital heart problems
- Infants of families who do not accept the study
- Infants with musculoskeletal system anomaly
- Infants connected to respiratory equipment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Motor Development, Infant, Premature, Diseases
- Being tested
- Peabody Developmental Motor Scale II (PDMS-2)
- Keywords
- validity, Peabody Developmental Motor Scale II (PDMS-2), motor development
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peabody Developmental Motor Scale II (PDMS-2)Diagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45-60 minutes
Secondary outcomes (2)
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.
Measured: 30-40 minutes
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.
Measured: 30-45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start10 Sep 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DevelopmentStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Comuk Balci, Ondokuz Mayıs University
- Investigators
- NILAY ÇÖMÜK BALCI, Pt,PhD, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886310
- Sponsor's protocol ID
- 41901325-050.99
- Status last verified
- Apr 2023
- First submitted
- 10 May 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability Study of Peabody Developmental Motor Scale-2 in Infants Aged 0 - 24 Months
- ClinicalTrials.gov ID
- NCT04886310
- Acronym / sponsor ID
- 41901325-050.99
- Conditions
- Motor Development, Infant, Premature, Diseases
- Keywords
- validity, Peabody Developmental Motor Scale II (PDMS-2), motor development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Infants with congenital heart problems
- Infants of families who do not accept the study
- Infants with musculoskeletal system anomaly
- Infants connected to respiratory equipment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
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.
2 secondary outcomes
The Alberta Infant Motor Scale (AIMS)
Time frame: 30-40 minutes
Hammersmith Infant Neurological Examination (HINE)
Time frame: 30-45 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NILAY ÇÖMÜK BALCI, Pt,PhD principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Development and Infant, Premature, Diseases, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peabody Developmental Motor Scale II (PDMS-2) (time frame: 45-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.