The Effect of Dual-tasking Program on Cognitive and Physical Functions and Independence in Activities of Daily Living in Children With Duchenne Muscular Dystrophy: A Single-blind Randomized Controlled Trial

NCT06887491 | Enrolling By Invitation

• 1 other identifier: 324S053
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Duchenne Muscular Dystrophy (DMD) is an X-linked recessive disorder characterized by progressive muscle degeneration and frequent developmental, cognitive and behavioral impairments, occurring in one in 5000 live births of boys. DMD is caused by a deficiency of the protein dystrophin, which maintains the structure and functionality of muscle cells. The absence of dystrophin leads to the weakening and eventual death of muscle cells, resulting in reduced muscle strength and impaired motor function. In early childhood, children with DMD may experience delays in basic motor skills such as walking and standing. Later in life, the disease leads to more severe motor dysfunctions, including loss of muscle strength, problems with balance and coordination, and an increased risk of falls. DMD can also negatively affect cognitive function. Dystrophin is found not only in muscles but also in the brain, and its deficiency in the brain can lead to cognitive problems such as learning disabilities, attention deficits and impaired executive function. These cognitive impairments can affect the academic performance of children with DMD and their functional abilities in everyday life. In this project, the potential effects of a dual task program designed for children with DMD on physical and cognitive functioning will be examined. Dual task training aims to increase children's capacity to perform two different tasks simultaneously, which may improve the integration of cognitive and motor functions. For example, activities such as counting while walking or answering a question while carrying an object in the hand require children to use both motor and cognitive skills simultaneously. Such exercises can increase coordination between cognitive and motor functions and improve the independence of children with DMD in activities of daily living and their overall quality of life. The main goals of the program are to produce positive effects on motor skills and cognitive functions, improve balance and coordination, and enable children to move more independently in activities of daily living. Furthermore, this study highlights the value of a multidisciplinary approach, providing important insights into how rehabilitation approaches can be developed for individuals with a special condition such as DMD. Collaboration between physiotherapists and occupational therapists plays a critical role in providing comprehensive care for these children. The methodology of this study included boys with DMD who were admitted to Lokman Hekim University Muscular and Nerve Diseases Application Center. The children will be randomly assigned to the intervention and control groups, and the children in the intervention group will be enrolled in a dual task performance program for two days a week, one session a day, 45 minutes each session, for eight weeks, with at least two days in between. The effectiveness of the program will be measured using various motor and cognitive assessment tools. The hypotheses of this study are that dual task training will positively affect motor and cognitive and physical functions in children with DMD, improve balance and coordination, and increase the level of independence of these children in activities of daily living. In conclusion, this project aims to contribute to the development of innovative approaches in the treatment of children with DMD. This approach can improve the overall quality of life of children, as well as support their social participation and educational achievement.

Conditions

Duchenne Muscular Dystrophy (DMD)

Keywords

dual task; activity; cognitive; physical

Outcome Measures

Primary Outcomes (11)

• Demographic information form

  Age (years), height (centimeters), body weight (kilograms) and body mass index (BMI) values of the children will be recorded. From the families of children with DMD, a detailed history of the disease will be obtained, including medical history, surname, DNA analysis result, age at diagnosis (years) and steroid use (name of steroid, dose, year of use), presence of scoliosis (if any, degree, year of onset) and functional status of the patient.

  Baseline

• Modified Mini-Mental Test

  The Modified Mini-Mental State Test (MMSE) will be used to evaluate the cognitive levels of children. Originally designed to identify cognitive impairments in adults, it is a quick and reliable tool with Turkish validity. While numerous neuropsychological tests are available for assessing cognitive skills in children, their lengthy administration and the need for professional expertise often limit their usability. The MMSE was therefore adapted with minor modifications for pediatric use and has been applied in children with DMD. This version assesses attention, orientation, memory, language skills, the ability to follow verbal and written commands, reading and writing abilities, and copying drawings. The test is scored out of 37, with values below 27 indicating potential mental retardation or dementia. Its simplicity and efficiency make it a practical choice for screening cognitive functions in children.

  Baseline

• Dual task assessment

  In the intervention group, dual-task performance will be evaluated in the first and last sessions, while the control group will be assessed eight weeks apart. The study includes motor-motor and cognitive-motor tasks, commonly used combinations in dual-task evaluations. The primary task is a 10-meter walk. The motor-motor task involves walking while carrying two 500 ml half-full bottles, considering the muscle weakness in children with DMD. The cognitive-motor tasks include backward counting, adapted to the child's age (e.g., a 6-year-old counts backward by ones from 10, a 12-year-old by sevens from 100) and recalling five previously provided age-appropriate words during the walk. The order of word recall is unimportant; any words remembered are recorded, and missed words are noted. Dual-task effect (DTE) will be calculated using the formula: DTE = ((dual-task performance - single-task performance) / single-task performance) × 100 Children will equally prioritize both tasks. Measuremen

  Baseline and 2 months

• Dynamic Occupational Therapy Cognitive Assessment-Child Version (DOTCA-ch)

  Developed by occupational therapists in 2004 as "Dynamic Occupational Therapy Cognitive Assessment-Child (DOTCA-ch)", the test was designed to assess the cognitive abilities and learning potential of children aged 6-12 years. As a performance-based test, the DOTCA-Ch has a different style in which children actively perform their cognitive assessments and, when deemed appropriate, can perform the test with help, and is frequently preferred by therapists. The assessment domains of the ADAS-C are processing speed, comprehension/problem solving, apraxia, attention/working memory, cognition and executive functions. It consists of 22 subtests in five cognitive domains (orientation, spatial perception, praxis, visual-motor interpretation and thinking processes). Five of the subtests of the Visual-Motor Interpretation test test test immediate and delayed memory.

  Baseline and 2 months

• Jebsen Taylor Hand Function Test

  In this test, a total of 7 different activities are applied, including checkers, collecting 6 small objects, feeding simulation, card spinning, carrying empty jars, carrying full jars and writing activities. The person will be asked to perform these activities with the dominant upper limb and the assessor will record the completion times of the activities.

  Baseline and 2 months

• 6 Minute Walk Test

  The 6-minute walk test (6MWD), which has proven validity and reliability in children with DMD, will be used to assess submaximal walking function and physical capacity. The distance the child walks for six minutes on a track with 25 meters between the start and end points will be recorded in meters. One researcher will walk with the child and ensure that the course is completed. Another researcher will record with a stopwatch, paper and pen to check the duration of each round and the total time. The 6DYT is a simple test to administer and is recognized as an important outcome measure for children with DMD

  Baseline and 2 months

• The Pediatric Berg Balance Scale

  The Pediatric Berg Balance Scale (PBBS) will be used to assess the balance of children. The PBBS is a 14-part test that includes parameters such as sitting to standing, standing, transfers, stepping, and turning and evaluates balance functionally. Each section is scored between 0-4 and the highest score that can be obtained from the scale is 56. High scores indicate good balance performance.

  Baseline and 2 months

• Pediatric Functional Independence Measure (WeeFIM)

  Pediatric Functional Independence Measure (WeeFIM) will be used to determine the independence level of children. WeeFIM consists of six sections and 18 items including self-care, sphincter control, transfers, locomotion, communication, social and cognitive domains, which are activities of daily living in children, and is administered by direct observation or interview with someone who can provide information about the child's performance. Each item is scored from complete independence (7 points) to fully assisted (1 point), with a minimum score of 18 (fully dependent) and a maximum score of 126 (fully independent). It is a quick and reliable scale suitable for use in the pediatric population, including children with DMD.

  Baseline and 2 months

• ACTIVLIM

  ACTIVLIM will be used to determine activity limitations in children with DMD. ACTIVLIM is a scale that can be used in all age groups to assess activity limitations in neuromuscular diseases and has Turkish validity and reliability. There are 22 items in total in the scale that evaluates activities of daily living that require the use of upper and lower extremities. In the scoring of the scale, 0= cannot do the activity, 1= has difficulty in doing the activity, 2= can do the activity easily and higher scores indicate less activity limitation.

  Baseline and 2 months

• The Pediatric Quality of Life Inventory (PedsQLTM) 3.0 Neuromuscular module

  The Turkish version of the Pediatric Quality of Life Inventory (PedsQLTM) 3.0 Neuromuscular module will be used to assess the quality of life of children with DMD. The PedsQLTM 3.0 Neuromuscular Module was created to assess quality of life in neuromuscular disorders such as DMD and SMA. The module consists of 25 items and has 3 subcategories: About My Neuromuscular Disease (17 items), Communication (3 items), About Family Resources (5 items). The PedsQLTM assesses the health-related quality of life of children with chronic diseases from the perspective of both the child and the family. The PedsQL scale, which is a questionnaire designed for children aged 2-18 years, has specialized forms for 2-4, 5-7, 8-12, 13-18 age ranges. Considering the inclusion criteria, the PedsQL scales developed for the 5-7 and 8-12 age ranges will be used in our study

  From enrollment to the end of treatment at 8 weeks

• Pediatric Quality of Life Inventory (PedsQL)- Multidimensional Fatigue Scale

  Pediatric Quality of Life Inventory (PedsQL)- Multidimensional Fatigue Scale will be used to assess the fatigue levels of children with DMD. The PedsQL-Multidimensional Fatigue Scale consists of 3 subsections and 18 items: General Fatigue (6 items), Fatigue during Sleep/Rest (6 items) and Cognitive Fatigue (6 items). The scale is scored on a 5-point Likert scale: Never: 0, Almost never: 1, Sometimes: 2, Frequently: 3, Always: 4. As a score, it is scored as 0=100, 1=75, 2=50, 3=25, 4=0 in the hundred point system. While a score can be calculated separately for each subsection, the total score is obtained by summing the scores obtained from the sections. High scores indicate low fatigue. The PedsQL-Multidimensional Fatigue Scale has child and parent forms for 2-4 years, 5-7 years, 8-12 years, and 13-18 years separated according to different age groups. In our study, the 5-7 and 8-12 years old child and parent form will be used to eval

  From enrollment to the end of treatment at 8 week

Other Outcomes (2)

• Vignos lower extremity classification

  Baseline

• Brooke upper limb functional classification

  Baseline

Study Arms (2)

Control

OTHER

Individuals in the control group will be enrolled in a classical physiotherapy program.

Other: Conventional physiotherapy program

Intervention

EXPERIMENTAL

Individuals in the intervention group will be enrolled in a dual task program in addition to the classical physiotherapy program.

Other: Conventional physiotherapy program + Dual task program

Interventions

Conventional physiotherapy program OTHER

Breathing exercises such as thoracic extension Stretching exercises for upper and lower extremity muscles Active-assisted, active and low resistance exercises for lower and upper extremity muscles according to muscle strength They will be asked to perform a home program including functional exercises (going up and down stairs, taking steps, etc.) at least 5 days a week, 2 times a day. The exercises will be checked by phone once a week and regular participation in the program will be ensured.

Control

Conventional physiotherapy program + Dual task program OTHER

Breathing exercises such as thoracic extension Stretching exercises for upper and lower extremity muscles Active-assisted, active and low resistance exercises for lower and upper extremity muscles according to muscle strength They will be asked to perform a home program including functional exercises (going up and down stairs, taking steps, etc.) at least 5 days a week, 2 times a day. The exercises will be checked by phone once a week and regular participation in the program will be ensured. Dual task program: Walking 10 meters (Single task) and basic dual task introduction. Simple motor-motor tasks (e.g., holding a ball while walking). Carrying a half-full water bottle in each hand while walking. Placing or carrying objects accompanied by exercises requiring balance. Counting Counting backwards while walking. Solving simple math problems while walking Complexification of motor-motor and cognitive-motor tasks. Dual tasks similar to activities of daily living

Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being a boy between the ages of 6-12 years who has been diagnosed with DMD as a result of specialist evaluation and gene analysis,
• Being in stage 1 and stage 2 according to Vignos lower extremity classification,
• A score of 27 and above on the Modified Mini-Mental Test,
• To have the ability to walk at least 10 meters independently,
• Receiving at least 8 physiotherapy and rehabilitation sessions for 1 month,
• Volunteering to participate in the study by their parents and reading and signing the informed consent form.

You may not qualify if:

• Having a neurological disease other than DMD and/or another diagnosed neurological disease accompanying DMD,
• To have had any injury and/or surgery within the last six months,
• Having a co-operation problem that prevents completing the assessments for any reason,
• Having difficulty understanding and speaking the Turkish language.

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Lokman Hekim University

Ankara, Cankaya, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Motor Activity

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; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 20, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 16, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

TU (1)