- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05990608
Peabody Developmental Motor Scaling In Children With Period Duchenne Muscular Dystrophy
August 6, 2023 updated by: Deniz Çakır, Ondokuz Mayıs University
The Validity and Reliability of The Peabody Developmental Motor Score In Children With Preschool Duchenne Muscular Dystrophy
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
48
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
-
-
-
Samsun, Turkey, 55270
- Ondokuz Mayıs University
-
-
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
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Ondokuz Mayıs University, Health Application and Research Center, Pediatric Neurology Outpatient Clinic and community samples
Description
Inclusion Criteria:
for Group I:
- No neurodevelopmental problems or diseases
- 3-5 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
- 3-5 years old
- Children who volunteered to participate in the study and whose parents' consent was obtained will be included in the study.
Exclusion Criteria:
- 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.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group I
Healthy Children
|
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 II
Children with DMD
|
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".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Peabody Developmental Motor Scales-2
Time Frame: This assessment will take place over the course of the study started and to the finish time
|
This assessment will take place over the course of the study started and to the finish time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Deniz Çakır, 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)
July 30, 2021
Primary Completion (Actual)
July 30, 2022
Study Completion (Actual)
July 30, 2023
Study Registration Dates
First Submitted
July 31, 2023
First Submitted That Met QC Criteria
August 6, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 6, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/371
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Duchenne Muscular Dystrophy (DMD)
-
Dyne TherapeuticsRecruitingMuscular Dystrophies | Muscular Dystrophy, Duchenne | Duchenne Muscular Dystrophy (DMD) | Muscular Dystrophy, Duchenne and Becker Types | Genetic Disease, X-Linked | Genetic Disease, Inborn | DMD | Congenital, Hereditary, and Neonatal Diseases and Abnormalities | Muscular Dystrophy (DMD) | Muscular Dystrophies... and other conditionsUnited States
-
Medical University of GdanskRecruitingDuchenne Muscular Dystrophy (DMD)Poland
-
PepGen IncWithdrawnDuchenne Muscular Dystrophy (DMD)United Kingdom
-
ItalfarmacoCompletedDuchenne Muscular Dystrophy (DMD)Italy
-
Santhera PharmaceuticalsTerminatedDuchenne Muscular Dystrophy (DMD)United States, Spain, Netherlands, Sweden, Germany, France, Belgium, United Kingdom, Italy, Ireland, Switzerland, Austria, Bulgaria, Hungary, Israel
-
Sarepta Therapeutics, Inc.CompletedDuchenne Muscular Dystrophy (DMD)United States
-
General Hospital of Chinese Armed Police ForcesUnknownDuchenne Muscular Dystrophy (DMD)China
-
Universitaire Ziekenhuizen KU LeuvenRecruitingDuchenne Muscular Dystrophy (DMD)Belgium
-
Peking Union Medical College HospitalActive, not recruitingDuchenne Muscular Dystrophy (DMD)China
-
Sarepta Therapeutics, Inc.CompletedDuchenne Muscular Dystrophy (DMD)United States
Clinical Trials on Peabody Developmental Motor Scales-2, PDMS
-
Ondokuz Mayıs UniversityCompletedInfant, Premature, Diseases | Motor DevelopmentTurkey
-
Yeditepe UniversityNot yet recruitingNeurodevelopmental DisordersTurkey (Türkiye)
-
Cairo UniversityCompleted
-
Nigde Omer Halisdemir UniversityCompletedSleep | Motor Development | Colic, Infantile | Sensory Integration DysfunctionTurkey
-
Gazi UniversityCompletedMotor Development | Congenital Muscular Torticollis | Sensory Integration DisorderTurkey
-
Gazi UniversityCompleted
-
Nigde Omer Halisdemir UniversityCompletedSensory Processing Disorder | Infant Development | PacifierTurkey
-
Istanbul Medipol University HospitalCompletedVisual Impairment | Motor Delay | Premature RetinopathyTurkey
-
Gazi UniversityCompletedSleep | Motor Development | Late Preterm InfantTurkey
-
Nigde Omer Halisdemir UniversityCompletedMotor Development | Sepsis Newborn | Sensory Integration DysfunctionTurkey