Dual Task in Duchenne Muscular Dystrophy

NCT05575648 | Completed

• 1 other identifier: 2022/13-45
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to determine the effects of the dual-task performance of children with DMD with motor dysfunction and varying degrees of cognitive impairment compared to their healthy peers, to compare the dual-task performance of children with different functional levels, and to determine the relationship between parameters that may affect dual-task performance.

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne Muscular Dystrophy; Dual task; Balance; Gait

Outcome Measures

Primary Outcomes (3)

• Dual task performance- 10 meter walk test

  The time is measured after 10 meter walk completed

  only baseline

• Dual task performance- 10 meter walk test with cognitive task

  The time is measured after 10 meter walk with a cognitive (memory and mental) task completed

  only baseline

• Dual task performance- 10 meter walk test with motor task

  The time is measured after 10 meter walk with a motor task completed

  only baseline

Secondary Outcomes (14)

• Functional level- Brooke Lower Extremity Functional Classification

  only baseline

• Ambulation level- North star ambulatory assessment

  only baseline

• Performance- 6 minutes walk test

  only baseline

• Balance - Pediatric berg balance scale

  only baseline

• Balance - Four square step test

  only baseline

Study Arms (2)

Duchenne Muscular Dystrophy

OTHER

Children who have been diagnosed with Duchenne Muscular Dystrophy.

Other: 10 meter walk test

Healthy Subjects

ACTIVE COMPARATOR

Children who have a normal motor and cognitive development.

Other: 10 meter walk test

Interventions

10 meter walk test OTHER

To assess the dual task performance of children 10 meter walk test will be used.

Duchenne Muscular Dystrophy; Healthy Subjects

Eligibility Criteria

• Age: 6 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Having been diagnosed with DMD by a pediatric neurologist,
• Must be at least 6 years old and have the ability to walk 10 meters independently,
• Being able to cooperate with the instructions given by the physiotherapist,
• Not having undergone surgery in the last 6 months and not having any injuries,

You may not qualify if:

• Failure to cooperate with the physiotherapist who made the evaluations,
• Have had any injury and/or surgery in the last 6 months,
• Children without consent will not be included.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Oznur YILMAZ, Prof

  Hacetteoe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 12, 2022
• Study Start: September 6, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)