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

NCT05436210 | Completed

• 1 other identifier: GO 22/414
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Duchenne Muscular Dystrophy; Ambulation Difficulty; Posture Disorders in Children; Ambulation Disorder, Neurologic

Keywords

Duchenne Muscular Dystrophy; foot posture; performance; ambulation

Outcome Measures

Primary Outcomes (4)

• foot posture index - 6

  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.

  10 minutes

• 6 min walk test (6MWT)

  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.

  6 minutes

• north star ambulation assessment

  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

  10 minutes

• timed performance test

  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.

  ten minutes

Interventions

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

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Ambulated Duchenne Muscular Dystrophy patients aged of 5-18 years

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead
• Suleyman Demirel University: collaborator

Study Sites (1)

Güllü Aydın Yağcıoğlu

Isparta, 32100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Mobility Limitation; Gait Disorders, Neurologic

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: June 23, 2022
• Primary Completion: October 20, 2022
• Study Completion: November 23, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

TU (1)