NCT05641805

Brief Summary

Although there are studies showing that the effect on motor performance over time in children with DMD is associated with a decrease in the level of physical activity, no publication has been found that directly examines the relationship between cognitive functions and physical activity level. Therefore, the aim of our study is to investigate the relationship between physical activity level and cognitive functions in children with DMD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 29, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

November 29, 2022

Last Update Submit

February 8, 2023

Conditions

Duchenne Muscular Dystrophy

Keywords

muscular dystrophyphysical activitycognitive function

Outcome Measures

Primary Outcomes (3)

  • PAQ-C

    Physical activity level

    10 to 15 minutes

  • MoCA

    Cognitive function

    10 to 15 minutes

  • Modified Mini Mental State Examination

    Cognitive function

    10 to 15 minutes

Secondary Outcomes (2)

  • PBS

    10 to 15 minutes

  • BMI

    1 minute

Study Arms (1)

Duchenne Muscular Dystrophy

Other: PAQ-C (Physical activitiy questionare for children), MoCA (Montreal Cognitive Assessment), PBS (Pediatric Balance Scale), Modified Mini Mental State Examination, BMI (Body Mass Index)

Interventions

PAQ-C (Physical activitiy questionare for children), MoCA (Montreal Cognitive Assessment), PBS (Pediatric Balance Scale), Modified Mini Mental State Examination, BMI (Body Mass Index)OTHER

PAQ-C will use to evaluate physical activity level of participants. MoCA and Modified Mini Mental State Examination will use to evaluate cognitive functions of participants. PBS will use to evaluate participants' balance responses.

Duchenne Muscular Dystrophy

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory children with Duchenne muscular dystrophy, between the ages of 8-14

You may qualify if:

  • Children who diagnosed with Duchenne Muscular Dystrophy (DMD), between the ages of 8-14, to have cognitive functions at a level to understand and apply test directives, Level 1-5 according to Brooke lower extremity functional classification will be included.

You may not qualify if:

  • Children who have any chronic or systemic disease in addition to DMD, being above level 5 according to the Brooke lower extremity functional classification, have a cooperation problem, have had any lower/upper extremity injury and/or surgery in the last 6 months and children who did not give consent will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Altındağ, Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneMuscular DystrophiesMotor Activity

Interventions

Mental Status and Dementia TestsBody Mass Index

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisAnthropometryInvestigative TechniquesPhysiological PhenomenaBiometryEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Bayram Sırrı, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bayram Sırrı, PT, MSc,

CONTACT

+905362410774bayramsirri@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 8, 2022

Study Start

November 29, 2022

Primary Completion

June 1, 2023

Study Completion

November 1, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Locations

TU(1)