NCT06868784

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

May 10, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

May 10, 2024

Last Update Submit

February 20, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Demographic information form

    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.

    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.

    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.

    one-time evaluation

  • Canadian Occupational Performance Measure

    It will be used to assess children's occupational performance.

    one-time evaluation

Study Arms (2)

Children with Duchenne muscular dystrophy

Other: Evaluations

Healthy control group of children

Other: Evaluations

Interventions

Evaluations of executive functions and occupational performance

Children with Duchenne muscular dystrophyHealthy control group of children

Eligibility Criteria

Age6 Years - 12 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All boys diagnosed with DMD between the ages of 6-12 years constitute the population of this study.

You may qualify if:

  • Being diagnosed with DMD
  • Volunteering to participate in the study by their parents and reading and signing the informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University

Ankara, Çankaya, 06510, 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 Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 10, 2024

First Posted

March 11, 2025

Study Start

March 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations