Executive DysfunctionNCT06868784
Investigation of the Relationship Between Executive Functions and Occupational Performance of Children With Duchenne Muscular Dystrophy
An observational study of Executive Dysfunction and Occupational Problems, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
The effects of Duchenne muscular dystrophy and its treatments on executive functions and occupational performance are under-mentioned in the literature. The researches believe that developmental and cognitive research is needed to identify interventions for children with DMD to identify and adapt to both individual… Read more about this study
- Who is it for?
- Ages 6 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Executive Dysfunction, Occupational Problems, Duchenne Muscular Dystrophy
- What is being tested?
- Evaluations
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Study population: All boys diagnosed with DMD between the ages of 6-12 years constitute the population of this study.
Who may be able to join
- Being diagnosed with DMD
- Volunteering to participate in the study by their parents and reading and signing the informed consent form
Who cannot join
- Having a neuromuscular disease other than DMD and/or another diagnosed neuromuscular disease accompanying DMD
- The family and/or the child has problems with cooperation in completing the assessments for any reason
- Difficulty understanding and speaking the Turkish language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Lokman Hekim University
Ankara, Çankaya, 06510
About this study
The effects of Duchenne muscular dystrophy and its treatments on executive functions and occupational performance are under-mentioned in the literature. The researches believe that developmental and cognitive research is needed to identify interventions for children with DMD to identify and adapt to both individual and social environments, including self-care, productivity and leisure activities. Therefore, the aim of this study was to examine executive functions and occupational performance in children with DMD and compare them with healthy controls.
- Being tested
- Evaluations
- 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.
EvaluationsOther
Evaluations of executive functions and occupational performance
| Study group | Role | What they receive |
|---|---|---|
| Children with Duchenne muscular dystrophy | Not described Receives: Other: Evaluations | |
| Healthy control group of children | Not described Receives: Other: Evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic information form
Measured: one-time evaluation
Brooke upper extremity functional scale
It will be used to assess the functional level of the upper limbs of children with DMD. The classification consists of six stages and progression from the first to the sixth stage indicates a decrease in the functionality of the upper limb.
Measured: one-time evaluation
Vignos lower extremity functional scale
It will be used to assess the functional level of the lower limbs of children with DMD. The classification consists of ten stages and progression from the first to the tenth stage indicates a decrease in the functionality of the upper limb.
Measured: one-time evaluation
The Childhood Executive Functioning Inventory
This 26-item scale consists of 4 subscales: working memory (9 items), planning (6 items), inhibition (6 items) and regulation (5 items). Working memory and planning sub-dimensions constitute the total score of "working memory" and inhibition and regulation sub-dimensions constitute the total score of "inhibition". As the score obtained from the scale increases, the child's executive functions weaken.
Measured: one-time evaluation
Canadian Occupational Performance Measure
It will be used to assess children's occupational performance.
Measured: one-time evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive DysfunctionStudies 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
- Prospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Başak Çağla Arslan, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868784
- Sponsor's protocol ID
- 2023025
- Status last verified
- Feb 2026
- First submitted
- 10 May 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patient data in this study will not be shared with other researchers. The results of the study will be shared after anonymizing the demographic information of DMD and healthy children.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Executive Functions and Occupational Performance of Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT06868784
- Acronym / sponsor ID
- 2023025
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (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.
The effects of Duchenne muscular dystrophy and its treatments on executive functions and occupational performance are under-mentioned in the literature. The researches believe that developmental and cognitive research is needed to identify interventions for children with DMD to identify and adapt to both individual and social environments, including self-care, productivity and leisure activities. Therefore, the aim of this study was to examine executive functions and occupational performance in children with DMD and compare them with healthy controls.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Duchenne muscular dystrophy | – | Other: Evaluations |
| Healthy control group of children | – | Other: Evaluations |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All boys diagnosed with DMD between the ages of 6-12 years constitute the population of this study.
Key inclusion criteria (2 listed)
- Being diagnosed with DMD
- Volunteering to participate in the study by their parents and reading and signing the informed consent form
Key exclusion criteria (3 listed)
- Having a neuromuscular disease other than DMD and/or another diagnosed neuromuscular disease accompanying DMD
- The family and/or the child has problems with cooperation in completing the assessments for any reason
- Difficulty understanding and speaking the Turkish language
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 |
|---|---|---|
| EvaluationsEvaluations of executive functions and occupational performance | Other | Children with Duchenne muscular dystrophy, Healthy control group of children |
Primary outcome
Demographic information form
Time frame: one-time evaluation
Brooke upper extremity functional scale
Time frame: one-time evaluation
It will be used to assess the functional level of the upper limbs of children with DMD. The classification consists of six stages and progression from the first to the sixth stage indicates a decrease in the functionality of the upper limb.
Vignos lower extremity functional scale
Time frame: one-time evaluation
It will be used to assess the functional level of the lower limbs of children with DMD. The classification consists of ten stages and progression from the first to the tenth stage indicates a decrease in the functionality of the upper limb.
The Childhood Executive Functioning Inventory
Time frame: one-time evaluation
This 26-item scale consists of 4 subscales: working memory (9 items), planning (6 items), inhibition (6 items) and regulation (5 items). Working memory and planning sub-dimensions constitute the total score of "working memory" and inhibition and regulation sub-dimensions constitute the total score of "inhibition". As the score obtained from the scale increases, the child's executive functions weaken.
Canadian Occupational Performance Measure
Time frame: one-time evaluation
It will be used to assess children's occupational performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided. Patient data in this study will not be shared with other researchers. The results of the study will be shared after anonymizing the demographic information of DMD and healthy children.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Executive Dysfunction and Occupational Problems, run by Lokman Hekim 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 2 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: enrolling by invitation, as of the sponsor's last update on 23 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Demographic information form (time frame: one-time evaluation). The study lists 5 primary outcomes in all. 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 23 Feb 2026.