Duchenne Muscular Dystrophy (DMD)NCT05990608
Peabody Developmental Motor Scaling In Children With Period Duchenne Muscular Dystrophy
An observational study of Duchenne Muscular Dystrophy (DMD), run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- Peabody Developmental Motor Scales-2, PDMS
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2021to 30 Jul 2023
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Ondokuz Mayıs University, Health Application and Research Center, Pediatric Neurology Outpatient Clinic and community samples
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- Peabody Developmental Motor Scales-2, PDMS
- Keywords
- Duchenne Muscular Dystrophy (DMD), Peabody Developmental Motor Scales-2
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peabody Developmental Motor Scales-2, PDMSOther
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".
| Study group | Role | What they receive |
|---|---|---|
| Group I | Healthy Children Receives: Other: Peabody Developmental Motor Scales-2, PDMS | |
| Group II | Children with DMD Receives: Other: Peabody Developmental Motor Scales-2, PDMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peabody Developmental Motor Scales-2
Measured: This assessment will take place over the course of the study started and to the finish time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start30 Jul 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Çakır, Ondokuz Mayıs University
- Investigators
- Deniz Çakır, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990608
- Sponsor's protocol ID
- 2021/371
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of The Peabody Developmental Motor Score In Children With Preschool Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT05990608
- Acronym / sponsor ID
- 2021/371
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Keywords
- Duchenne Muscular Dystrophy (DMD), Peabody Developmental Motor Scales-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 14 Aug 2023 (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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: Peabody Developmental Motor Scales-2, PDMSHealthy Children |
| Group II | – | Other: Peabody Developmental Motor Scales-2, PDMSChildren with DMD |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Ondokuz Mayıs University, Health Application and Research Center, Pediatric Neurology Outpatient Clinic and community samples
Key inclusion criteria (9 listed)
- for Group I:
- for Group II:
Key exclusion criteria (3 listed)
- 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.
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 Scales-2, PDMSThe 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". | Other | Group I, Group II |
Primary outcome
Peabody Developmental Motor Scales-2
Time frame: This assessment will take place over the course of the study started and to the finish time
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 14 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Deniz Çakır 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 Duchenne Muscular Dystrophy (DMD), 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 9 inclusion and 3 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 14 Aug 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 Scales-2 (time frame: This assessment will take place over the course of the study started and to the finish time). 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 14 Aug 2023.