Factors Influencing Physical Activity Levels in Children With Duchenne Muscular Dystrophy: An ICF-CY-Based Study

January 27, 2026 updated by: Serenay Zorlu, Hacettepe University

Investigation of Factors Affecting Physical Activity Level in Children With Duchenne Muscular Dystrophy Based on the International Classification of Functioning, Disability and Health - Child and Youth Version

Duchenne Muscular Dystrophy (DMD) is a neuromuscular disease characterized not only by progressive muscle weakness but also by cognitive, behavioral, and psychosocial impairments. Motor losses that occur during disease progression reduce physical activity levels in children and increase the risk of developing a sedentary lifestyle. Interventions aimed at maintaining or promoting physical activity in children with DMD are important for preventing secondary complications associated with disuse and physical inactivity. To develop effective interventions, there is a need for comprehensive knowledge regarding the factors that influence physical activity levels.

Current literature indicates that, in typically developing children, physical activity levels are influenced not only by motor factors but also by cognitive status, sleep, behavioral characteristics, and family-related environmental and psychosocial factors. However, information regarding these multidimensional factors affecting physical activity levels in children with DMD remains limited.

This study aims to identify the body functions, activity, participation, environmental, and personal factors affecting physical activity levels in children with DMD based on the framework of the International Classification of Functioning, Disability and Health - Children and Youth Version (ICF-CY). Accordingly, the effects of posture, functional capacity, ambulatory status, balance, other musculoskeletal parameters, cognitive status, sleep habits and sleep quality, fear of falling, and behavioral characteristics, as well as family-related factors including parenting style, perceptions of physical activity, stress level, attitudes and perceptions toward daily life events, and disease impact, will be evaluated. The impact of these variables on physical activity levels and the magnitude of this effect will be examined within the ICF-CY framework.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Duchenne Muscular Dystrophy (DMD) is the most common inherited neuromuscular disorder, affecting approximately one in 3,500-5,000 live male births worldwide. It is caused by various mutations in the dystrophin gene located on Xp21.2, most commonly deletions and duplications, leading to the absence of dystrophin protein in skeletal muscle, cardiac muscle, and the central nervous system. The lack of dystrophin results in progressive muscle weakness beginning in early childhood, typically between 18 months and 3 years of age, followed by gradual loss of ambulation, increasing dependence in daily activities, and the development of serious cardiac, respiratory, and orthopedic complications later in life.

In addition to motor impairments, dystrophin deficiency in the brain has been associated with cognitive, behavioral, and psychosocial difficulties. DMD-related mutations affect multiple dystrophin isoforms that are expressed in key brain regions involved in attention, memory, executive functions, and emotional regulation. As a result, children with DMD frequently present with impairments in attention, executive functioning, learning, behavior, and emotional regulation. These non-motor manifestations further complicate disease management and have a substantial impact on participation in daily life and overall quality of life for both children and their families.

During disease progression, increasing motor limitations significantly restrict children's engagement in physical activity and increase the likelihood of adopting a sedentary lifestyle. Reduced physical activity contributes to secondary complications related to disuse, such as decreased cardiorespiratory fitness, reduced bone mineral density, increased fatigue, and further functional decline. Therefore, maintaining and supporting physical activity is considered a critical component of comprehensive care in children with DMD. However, the development of effective and sustainable physical activity-related interventions requires a thorough understanding of the factors influencing physical activity behavior in this population.

In typically developing children, physical activity levels are known to be influenced by a wide range of motor and non-motor factors, including physical function, cognitive status, sleep habits, behavioral characteristics, and family-related environmental and psychosocial factors. Although similar interactions are likely to exist in children with DMD, current evidence regarding the multidimensional determinants of physical activity in this population remains limited. In particular, the combined influence of body functions, activity limitations, participation restrictions, and family-related factors has not been sufficiently investigated within a comprehensive conceptual framework.

The International Classification of Functioning, Disability and Health - Children and Youth Version (ICF-CY), developed by the World Health Organization, provides a biopsychosocial model that enables a holistic evaluation of health by considering body functions and structures, activity, participation, and contextual factors. Using the ICF-CY framework allows for the systematic examination of the dynamic interactions between individual and environmental factors that shape physical activity behavior in children with chronic health conditions.

Therefore, the primary aim of this study is to identify the factors affecting physical activity levels in children with Duchenne Muscular Dystrophy within the ICF-CY framework. Specifically, the study will evaluate the influence of posture, functional capacity, ambulatory status, balance, fatigue, gait, and other musculoskeletal parameters, as well as cognitive status, sleep habits and sleep quality, fear of falling, behavioral characteristics, and motivation on children's physical activity levels. In addition, family-related factors-including caregiver sleep quality, parenting style, perceptions of physical activity, stress level, attitudes and perceptions toward daily life events, and perceived disease impact-will be examined to determine their contribution to physical activity behavior.

By adopting a comprehensive ICF-CY-based approach, this study aims to clarify the relative contribution and magnitude of individual, environmental, and psychosocial factors influencing physical activity levels in children with DMD. The findings are expected to provide clinically relevant insights that may guide the development of targeted, family-centered, and multidimensional interventions aimed at maintaining or enhancing physical activity and improving long-term health outcomes and quality of life in children with Duchenne Muscular Dystrophy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: İpek Gürbüz, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of children diagnosed with Duchenne Muscular Dystrophy (DMD) and their parents or primary caregivers. Eligible children will be males aged 6 to 14 years with a confirmed diagnosis of DMD who are ambulatory, classified within the first four levels of the Brooke Lower Extremity Functional Classification, and able to follow assessment instructions. Parents or primary caregivers of these children who voluntarily agree to participate will also be included. Participants will be recruited from pediatric neuromuscular rehabilitation and physiotherapy settings.

Description

  • Inclusion Criteria (Parents):

    1. Being a parent or primary caregiver of a child diagnosed with Duchenne Muscular Dystrophy (DMD),
    2. Volunteering to participate in the study.

  • Exclusion Criteria (Parents):

    1. Having caregiving responsibilities for another child or adult with a disability, other than the child with DMD,
    2. Experiencing difficulties in understanding or responding to the questionnaires administered by the physiotherapist.

  • Inclusion Criteria (Children with DMD):

    1. Having a confirmed diagnosis of Duchenne Muscular Dystrophy (DMD),
    2. Being between 6 and 14 years of age,
    3. Being classified within the first four levels of the Brooke Lower Extremity Functional Classification (ambulatory children),
    4. Scoring >24 on the Modified Mini-Mental State Examination,
    5. Volunteering to participate in the study.

  • Exclusion Criteria (Children with DMD):

    1. Having undergone any musculoskeletal surgery or sustained an injury that could affect physical activity within the past 6 months,
    2. Experiencing difficulty in understanding the test instructions administered by the physiotherapist and therefore being unable to appropriately perform the tests (performance-based assessments),
    3. Experiencing difficulties in understanding or responding to the questionnaires administered by the physiotherapist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Activity Questionnaire for Children-PAQ-C
Time Frame: At baseline (single assessment at enrollment)
The physical activity level of children with DMD will be assessed using the Physical Activity Questionnaire for Children (PAQ-C).
At baseline (single assessment at enrollment)
The New York Posture Rating Chart
Time Frame: At baseline (single assessment at enrollment)
The New York Posture Rating Chart will be used to assess posture in children with DMD.
At baseline (single assessment at enrollment)
Six Minute Walk Test (6MWT)
Time Frame: At baseline (single assessment at enrollment)
The 6MWT will be used to evaluate functional capacity in children with DMD.
At baseline (single assessment at enrollment)
Pediatric Quality of Life Inventory - Multidimensional Fatigue Scale (PedsQL-MFS)
Time Frame: At baseline (single assessment at enrollment)
Fatigue in children with DMD will be assessed using the PedsQL-MFS.
At baseline (single assessment at enrollment)
Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)
Time Frame: At baseline (single assessment at enrollment)
Gait characteristics of children with DMD will be evaluated using the DMD-GAS.
At baseline (single assessment at enrollment)
North Star Ambulatory Assessment (NSAA)
Time Frame: At baseline (single assessment at enrollment)
Ambulatory status of children with DMD will be assessed using the NSAA.
At baseline (single assessment at enrollment)
Four Square Step Test (FSST)
Time Frame: At baseline (single assessment at enrollment)
Balance in children with DMD will be evaluated using the FSST.
At baseline (single assessment at enrollment)
Lower Extremity Muscle Strength Assessment
Time Frame: At baseline (single assessment at enrollment)
Myometric measurements will be performed to assess lower extremity muscle strength in children with DMD.
At baseline (single assessment at enrollment)
Assessment of Lower Extremity Joint Range of Motion
Time Frame: At baseline (single assessment at enrollment)
Active and passive range of motion of the lower extremity joints will be assessed using goniometric measurements.
At baseline (single assessment at enrollment)
Muscle Shortness Assessment
Time Frame: At baseline (single assessment at enrollment)
Muscle length tests will be applied to determine muscle shortness in children with DMD.
At baseline (single assessment at enrollment)
Modified Mini-Mental State Examination (MMSE)
Time Frame: At baseline (single assessment at enrollment)
The Modified MMSE will be used to determine the cognitive level of children with DMD.
At baseline (single assessment at enrollment)
Trail Making Test
Time Frame: At baseline (single assessment at enrollment)
The Trail Making Test will be used to assess cognitive functions such as attention, planning, and executive functions in children with DMD.
At baseline (single assessment at enrollment)
Children's Sleep Habits Questionnaire (CSHQ) - Short Form
Time Frame: At baseline (single assessment at enrollment)
The CSHQ will be used to assess sleep problems in children with DMD.
At baseline (single assessment at enrollment)
Pediatric Sleep Questionnaire - Sleep-Related Breathing Disorder Subscale (PSQ-SRBD)
Time Frame: At baseline (single assessment at enrollment)
The PSQ-SRBD subscale will be used to evaluate sleep-related breathing disorders in children with DMD.
At baseline (single assessment at enrollment)
ICF-Based Fear of Falling Form for Pediatric Neuromuscular Diseases (Ped-FOF)
Time Frame: At baseline (single assessment at enrollment)
The Ped-FOF will be used to assess fear of falling in children with DMD.
At baseline (single assessment at enrollment)
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: At baseline (single assessment at enrollment)
Behavioral problems in children with DMD will be assessed using the SDQ.
At baseline (single assessment at enrollment)
Pediatric Motivation Scale (PMS)
Time Frame: At baseline (single assessment at enrollment)
Motivation levels of children with DMD will be assessed using the PMS.
At baseline (single assessment at enrollment)
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At baseline (single assessment at enrollment)
Parental sleep quality will be evaluated using the PSQI.
At baseline (single assessment at enrollment)
Parenting Scale
Time Frame: At baseline (single assessment at enrollment)
The Parenting Scale will be used to assess parents' disciplinary practices.
At baseline (single assessment at enrollment)
Perceived Barriers to Physical Activity Scale
Time Frame: At baseline (single assessment at enrollment)
Parents' perceived barriers to participation in physical activity will be assessed using the Perceived Barriers to Physical Activity Scale.
At baseline (single assessment at enrollment)
Perceived Stress Scale (PSS)
Time Frame: At baseline (single assessment at enrollment)
Parental stress levels will be assessed using the PSS.
At baseline (single assessment at enrollment)
Cognitive Control and Flexibility Scale (CCFS)
Time Frame: At baseline (single assessment at enrollment)
The CCFS will be used to assess parents' cognitive flexibility in stressful situations.
At baseline (single assessment at enrollment)
Impact on Family Scale (IPFAM)
Time Frame: At baseline (single assessment at enrollment)
The level of disease-related impact on parents will be assessed using the IPFAM.
At baseline (single assessment at enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FTREK25/64

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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