Dual Task in Duchenne Muscular Dystrophy

NCT ID: NCT05575648

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2023-05-01

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.

Detailed Description

Children who are at least 6 years old and who can walk 10 meters independently, whose Duchenne's muscular dystrophy (DMD) diagnosis has been confirmed as a result of genetic testing, will be included in the study. To determine dual-task performance, the 10-meter Walk Test will be performed with additional motor and cognitive tasks. Functional level (Brooke Lower Extremity Functional Classification), ambulation level (North Star Ambulation Rating), muscular performance and functions (6 Minute Walk Test), balance (Pediatric Berg Balance Scale and four square step test), fear of falling (Fear of Falling Questionnaire), gait (Gait in DMD Assessment Scale, Gait Quality and Independence Classification Scale in DMD, and Functional Evaluation Scale for Duchenne Muscular Dystrophy-Gait Domain (FES-DMD-GD)), cognitive level (Modified Mini-Mental State Test (MMDT)), independence and activity limitation (Pediatric Functional Independence Measure (WeeFIM) and ACTIVLIM), quality of life (The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module Turkish version PedsQL-3.0 Neuromuscular Module) will be evaluated.

Conditions

Duchenne Muscular Dystrophy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Duchenne Muscular Dystrophy

Children who have been diagnosed with Duchenne Muscular Dystrophy.

Group Type: OTHER

10 meter walk test

Intervention Type: OTHER

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

Healthy Subjects

Children who have a normal motor and cognitive development.

Group Type: ACTIVE_COMPARATOR

10 meter walk test

Intervention Type: OTHER

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

Interventions

10 meter walk test

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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,

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Büşra Kayabınar

PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oznur YILMAZ, Prof

Role: STUDY_DIRECTOR

Hacetteoe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/13-45

Identifier Type: -

Identifier Source: org_study_id