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

NCT07369609 | Not Yet Recruiting DMC

• 1 other identifier: FTREK25/64
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Duchenne Muscular Dystrophy (DMD)

Keywords

duchenne muscular dystrophy; physical activity; ICF-CY

Outcome Measures

Primary Outcomes (23)

• Physical Activity Questionnaire for Children-PAQ-C

  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

  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)

  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)

  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)

  Gait characteristics of children with DMD will be evaluated using the DMD-GAS.

  At baseline (single assessment at enrollment)

• North Star Ambulatory Assessment (NSAA)

  Ambulatory status of children with DMD will be assessed using the NSAA.

  At baseline (single assessment at enrollment)

• Four Square Step Test (FSST)

  Balance in children with DMD will be evaluated using the FSST.

  At baseline (single assessment at enrollment)

• Lower Extremity Muscle Strength Assessment

  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

  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

  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)

  The Modified MMSE will be used to determine the cognitive level of children with DMD.

  At baseline (single assessment at enrollment)

• Trail Making Test

  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

  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)

  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)

  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)

  Behavioral problems in children with DMD will be assessed using the SDQ.

  At baseline (single assessment at enrollment)

• Pediatric Motivation Scale (PMS)

  Motivation levels of children with DMD will be assessed using the PMS.

  At baseline (single assessment at enrollment)

• Pittsburgh Sleep Quality Index (PSQI)

  Parental sleep quality will be evaluated using the PSQI.

  At baseline (single assessment at enrollment)

• Parenting Scale

  The Parenting Scale will be used to assess parents' disciplinary practices.

  At baseline (single assessment at enrollment)

• Perceived Barriers to Physical Activity Scale

  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)

  Parental stress levels will be assessed using the PSS.

  At baseline (single assessment at enrollment)

• Cognitive Control and Flexibility Scale (CCFS)

  The CCFS will be used to assess parents' cognitive flexibility in stressful situations.

  At baseline (single assessment at enrollment)

• Impact on Family Scale (IPFAM)

  The level of disease-related impact on parents will be assessed using the IPFAM.

  At baseline (single assessment at enrollment)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Gender Eligibility Details: Individuals of all self-identified genders are eligible to participate in the study.
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Having caregiving responsibilities for another child or adult with a disability, other than the child with DMD,
• Experiencing difficulties in understanding or responding to the questionnaires administered by the physiotherapist.
• Having a confirmed diagnosis of Duchenne Muscular Dystrophy (DMD),
• Being between 6 and 14 years of age,
• Being classified within the first four levels of the Brooke Lower Extremity Functional Classification (ambulatory children),
• Scoring \>24 on the Modified Mini-Mental State Examination,
• Volunteering to participate in the study.
• Having undergone any musculoskeletal surgery or sustained an injury that could affect physical activity within the past 6 months,
• Experiencing difficulty in understanding the test instructions administered by the physiotherapist and therefore being unable to appropriately perform the tests (performance-based assessments),
• Experiencing difficulties in understanding or responding to the questionnaires administered by the physiotherapist.

Sponsors & Collaborators

• Hacettepe University: lead

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

Central Study Contacts

Serenay Zorlu Develik, PhD Candidate

CONTACT

+90 546 665 33 11; serenayyzorlu@gmail.com

İpek Gürbüz, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): September 2, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01