Clinical trial NCT05575648: Dual Task in Duchenne Muscular Dystrophy
Official title: Investigation of Dual Task Performance in Children With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne Muscular Dystrophy
Dual task
Balance
Gait
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 94
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Dual task performance- 10 meter walk test
timeFrame: only baseline
measure: Dual task performance- 10 meter walk test with cognitive task
timeFrame: only baseline
measure: Dual task performance- 10 meter walk test with motor task
timeFrame: only baseline
Secondary outcomes:
measure: Functional level- Brooke Lower Extremity Functional Classification
timeFrame: only baseline
measure: Ambulation level- North star ambulatory assessment
timeFrame: only baseline
measure: Performance- 6 minutes walk test
timeFrame: only baseline
measure: Balance - Pediatric berg balance scale
timeFrame: only baseline
measure: Balance - Four square step test
timeFrame: only baseline
measure: Fear of falling - Pediatric Fear of Falling Questionnaire
timeFrame: only baseline
measure: Fall frequency
timeFrame: only baseline
measure: Gait - Gait Evaluation Scale in Duchenne Muscular Dystrpohy
timeFrame: only baseline
measure: Gait - Gait Classification Scale in Duchenne Muscular Dystrpohy
timeFrame: only baseline
measure: Gait - Functional Evaluation Scale for Duchenne Muscular Dystrophy-Gait Domain
timeFrame: only baseline
measure: Cognitive level - Modified Mini Mental Test
timeFrame: only baseline
measure: Activity of daily living - The Functional Independence Measure for Children (WeeFIM)
timeFrame: only baseline
measure: Activity of daily living - ACTIVLIM
timeFrame: only baseline
measure: Quality of life - The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module Turkish version PedsQL-3.0
timeFrame: only baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacetteoe University
name: Oznur YILMAZ, Prof
role: STUDY_DIRECTOR
References: