NCT06379906

Brief Summary

This study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 10, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

April 18, 2024

Last Update Submit

April 24, 2024

Conditions

Duchenne Muscular Dystrophy

Keywords

duchenne muscular dystrophyupper extremitybalancefunctional skills

Outcome Measures

Primary Outcomes (4)

  • Upper Extremity Muscle Strength Measurements

    one time (baseline)

  • Trunk Control Measurement Scale

    one time (baseline)

  • Functional Reach Test

    one time (baseline)

  • Timed Up & Go Test

    one time (baseline)

Secondary Outcomes (1)

  • Pediatric Evaluation of Disability Inventory

    one time (baseline)

Interventions

AssessmentOTHER

Baseline assessment

Eligibility Criteria

Age5 Years - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Participants who applied to the Child Neurology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine, Department of Child Health and Diseases

You may qualify if:

  • 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

You may not qualify if:

  • had undergone a surgical operation in the last 6 months
  • had contractures that would affect functional activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haliç University

Istanbul, Eyüpsultan, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • GÜLSENA UTKU UMUT

    HALİÇ UNİVERSİTY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 23, 2024

Study Start

November 10, 2023

Primary Completion

December 10, 2023

Study Completion

March 10, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

TU(1)