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NCT Number: NCT05436210

Postural and Anthropometric Properties of Foot and Ankle of Patients With DMD

Introduction: Progressive muscle weakness, joint contractures and body alignment disorders seen in patients with Duchenne Muscular Dystrophy (DMD) adversely affect the foot structure of the patients.

Objective: The aim of this study is to examine the relationship between foot posture, performance and ambulation in patients with DMD.

Method: The patient with ambulatory DMD will be included in the study. The foot postures of the patients will be evaluated with the Foot Posture Index. Relationships between the Foot Posture Index and performance tests (6 minute walk test, timed performance tests (10m walking, Gower's, climb/descend 4 stair)) and the North Star Ambulation Evaluation, an ambulation evaluation, will be examined.

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Key information

Conditions

Duchenne Muscular Dystrophy Ambulation Difficulty Ambulation Disorder, Neurologic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gait Disorders, Neurologic Genetic Diseases, Inborn Genetic Diseases, X-Linked Mobility Limitation Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Posture Disorders in Children Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Güllü Aydın Yağcıoğlu

Isparta, 32100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.5 to 18 years old 2. Not to have lost his ambulation 3. Agreeing to participate in the research voluntarily

Exclusion criteria

  • Having serious mental and psychological problems,
  • Having lost his ambulation
  • Inability to cooperate adequately with the physiotherapist who made the evaluations,
  • Any injury and/or surgery to the lower extremities in the last 6 months.

Treatment and study plan

foot posture index, north star ambulation assessment, timed performance tests, 6 minute walk test

Other

Patients will be evaluated only observationally without intervention by foot posture index, north star ambulation assessment, timed performance tests, 6 minute walk test

Primary outcomes

  1. foot posture index - 6

    Time frame: 10 minutes

    The Foot Posture Index - 6 (FPI-6) was evaluated with each child standing and using the original protocol. FPI-6 values ranged from -2 to +2 for each of the six criteria and from -12 to +12 for the total score, indicative of position of each foot along the supinated to pronated continuum of foot posture.

  2. 6 min walk test (6MWT)

    Time frame: 6 minutes

    Six Minute Walk Test was used commonly in DMD were found to be valid, reliable and easy to apply in the clinic. Children were asked to walk during 6 minutes as fast as they can at a corridor specified by two cones and walking distances were recorded as meter (m) for 6MWT. The time passed during timed performance tests were recorded as seconds.

  3. north star ambulation assessment

    Time frame: 10 minutes

    Patients' ambulation will be evaluated with the North Star Ambulation Assessment (NSAA). The NSAA consists of 17 items and evaluates ambulation with functional activities such as walking, getting up from a chair, going up and down stairs, and running. Each item is scored in the range of 0-2 points and the total score is in the range of 0-34. High score indicates better ambulation status

  4. timed performance test

    Time frame: ten minutes

    Ascending-descending standard 4 steps, walking 10m, standing from lying position were used in order to assess the performance of children.The time passed during timed performance tests were recorded as seconds.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Suleyman Demirel University

Registry information

Official study title

The Impact of Postural and Anthropometric Properties of Foot and Ankle on Physical Performance and Ambulation of Patients With Duchenne Muscular Dystrophy

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2022
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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