Duchenne Muscular DystrophyNCT06379906
Upper Extremity Muscle Strength, Balance and Functional Skills in DMD
An observational study of Duchenne Muscular Dystrophy, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD. Read more about this study
- Who is it for?
- Ages 5 to 12 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Assessment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2023to 10 Mar 2024
- How long will I take part?
- 1 Day
- 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 5 to 12 years
- Men only
- No healthy volunteers
- Child
Study population: Participants who applied to the Child Neurology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine, Department of Child Health and Diseases
Who may be able to join
- diagnosed with DMD by a child neurologist and confirmed by genetic test results,
- were at Level 1-4 according to Brooke Lower Extremity Functional Classification (able to ambulate independently and get up from a chair)
- had cooperation with the researchers
Who cannot join
- had undergone a surgical operation in the last 6 months
- had contractures that would affect functional activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Upper Extremity Muscle Strength, Balance and Functional Skills in Children With Duchenne Muscular Dystrophy
This study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Assessment
- Keywords
- duchenne muscular dystrophy, upper extremity, balance, functional skills
- 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.
AssessmentOther
Baseline assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Muscle Strength Measurements
Measured: one time (baseline)
Trunk Control Measurement Scale
Measured: one time (baseline)
Functional Reach Test
Measured: one time (baseline)
Timed Up & Go Test
Measured: one time (baseline)
Secondary outcomes (1)
Pediatric Evaluation of Disability Inventory
Measured: one time (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start10 Nov 2023
- Primary completion10 Dec 2023
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- 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
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University, Istanbul University
- Responsible party
- Principal investigator, Gülsena Utku, Halic University
- Investigators
- GÜLSENA UTKU UMUT, Principal investigator, HALİÇ UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379906
- Sponsor's protocol ID
- DMD, UE and Balance
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Utku Umut G, Hosbay Z, Pempegul Yildiz E, Aydinli N. The Impact of Trunk Control and Balance on Functional Skills in Ambulatory Children With Duchenne Muscular Dystrophy. J Paediatr Child Health. 2026 May;62(5):738-745. doi: 10.1111/jpc.70331. Epub 2026 Feb 18.
PubMed 41708510
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Upper Extremity Muscle Strength, Balance and Functional Skills in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT06379906
- Acronym / sponsor ID
- DMD, UE and Balance
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- duchenne muscular dystrophy, upper extremity, balance, functional skills
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Biruni University, Istanbul University
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 23 Apr 2024 (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 aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 5 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants who applied to the Child Neurology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine, Department of Child Health and Diseases
Key inclusion criteria (3 listed)
- diagnosed with DMD by a child neurologist and confirmed by genetic test results,
- were at Level 1-4 according to Brooke Lower Extremity Functional Classification (able to ambulate independently and get up from a chair)
- had cooperation with the researchers
Key exclusion criteria (2 listed)
- had undergone a surgical operation in the last 6 months
- had contractures that would affect functional activities
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 |
|---|---|---|
| AssessmentBaseline assessment | Other | – |
Primary outcome
Upper Extremity Muscle Strength Measurements
Time frame: one time (baseline)
Trunk Control Measurement Scale
Time frame: one time (baseline)
Functional Reach Test
Time frame: one time (baseline)
Timed Up & Go Test
Time frame: one time (baseline)
1 secondary outcome
Pediatric Evaluation of Disability Inventory
Time frame: one time (baseline)
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 25 Apr 2024.
- Derived from this study: PubMed 41708510Utku Umut G, Hosbay Z, Pempegul Yildiz E, Aydinli N. The Impact of Trunk Control and Balance on Functional Skills in Ambulatory Children With Duchenne Muscular Dystrophy. J Paediatr Child Health. 2026 May;62(5):738-745. doi: 10.1111/jpc.70331. Epub 2026 Feb 18.
- 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.
GÜLSENA UTKU UMUT principal investigator
HALİÇ UNİVERSİTY
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, run by Halic 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 3 inclusion and 2 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 25 Apr 2024. 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?
Upper Extremity Muscle Strength Measurements (time frame: one time (baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06379906, which also lists 1 linked publication.
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 25 Apr 2024.