NCT05990608

Brief Summary

To perform the reliability and validity study of the Peabody Developmental Motor Scale (Peabody Developmental Motor Scales-2) in children with Duchenne Muscular Dystrophy (DMD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

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

July 30, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

July 31, 2023

Last Update Submit

August 6, 2023

Conditions

Keywords

Duchenne Muscular Dystrophy (DMD)Peabody Developmental Motor Scales-2

Outcome Measures

Primary Outcomes (1)

  • Peabody Developmental Motor Scales-2

    This assessment will take place over the course of the study started and to the finish time

Study Arms (2)

Group I

Healthy Children

Other: Peabody Developmental Motor Scales-2, PDMS

Group II

Children with DMD

Other: Peabody Developmental Motor Scales-2, PDMS

Interventions

The Peabody Developmental Engine Scales-2, PDMS, is a standardized norm-referenced test used to determine the motor skill level of children aged 0 to 6, identify delays in engine development, and determine individual needs and challenges. The 2 scalar, which allows children to evaluate rough and thin motor skills, consists of 6 sub-tests and 249 articles. The rough motor scale contains 4 sub-tests and 151 items, including reflex, equilibrium, locomotion and object manipulation. The slim motor scale consists of 2 sub-tests and 98 items, including cognition and visual-motor integration. Using the age-appropriate normal value ranges in the test manual to determine developmental stress risk and level, the coarse motor skills, slim motor skills, and general motor development are categorized as "very low, low, below average, above average, high, very high".

Group IGroup II

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Ondokuz Mayıs University, Health Application and Research Center, Pediatric Neurology Outpatient Clinic and community samples

You may qualify if:

  • for Group I:
  • No neurodevelopmental problems or diseases
  • years old
  • Being able to cooperate with the instructions given by the physiotherapist.
  • Children who volunteered to participate in the study and whose families gave consent form will be included in the study.
  • for Group II:
  • Being diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist
  • years old
  • Children who volunteered to participate in the study and whose parents' consent was obtained will be included in the study.

You may not qualify if:

  • Children with a behavioral condition and any disorder that interferes with testing (eg autism spectrum disorder)
  • Failure to cooperate with the physiotherapist who made the evaluations.
  • Lack of volunteers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, 55270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Deniz Çakır

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 14, 2023

Study Start

July 30, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations