NCT04886310

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

May 10, 2021

Last Update Submit

April 26, 2023

Conditions

Keywords

validityPeabody Developmental Motor Scale II (PDMS-2)motor development

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The Alberta Infant Motor Scale (AIMS)

    30-40 minutes

  • Hammersmith Infant Neurological Examination (HINE)

    30-45 minutes

Interventions

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.

Eligibility Criteria

Age1 Month - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Infants with congenital heart problems
  • Infants of families who do not accept the study
  • Infants with musculoskeletal system anomaly
  • Infants connected to respiratory equipment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nilay Çömük Balci

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • NILAY ÇÖMÜK BALCI, Pt,PhD

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pt, PhD, Associate Professor

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 14, 2021

Study Start

September 10, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations