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CompletedNCT05436210Updated Jan 4, 2023

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

An observational study in Duchenne Muscular Dystrophy, Ambulation Difficulty and Posture Disorders in Children, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to male participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by Hacettepe University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
5 Years to 18 Years
Sex
Male
01

Study 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.

02

Conditions studied

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

Keywords

  • Duchenne Muscular Dystrophy
  • foot posture
  • performance
  • ambulation
03

In context

Muscular Dystrophies

548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.

This study's enrollment of 48 is below the median of 69 across 179 observational studies indexed under Muscular Dystrophies.

Browse Muscular Dystrophies studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Ambulated Duchenne Muscular Dystrophy patients aged of 5-18 years

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

Exclusion Criteria:

  1. Having serious mental and psychological problems,
  2. Having lost his ambulation
  3. Inability to cooperate adequately with the physiotherapist who made the evaluations,
  4. Any injury and/or surgery to the lower extremities in the last 6 months.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

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

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 minutes

  2. 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.

    Time frame: 6 minutes

  3. 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

    Time frame: 10 minutes

  4. 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.

    Time frame: ten minutes

07

Study locations

1 site
  • Güllü Aydın Yağcıoğlu
    Isparta, 32100, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05436210
Lead sponsor
Hacettepe University
Collaborators
Suleyman Demirel University
Responsible party
Güllü AYDIN YAĞCIOĞLU (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Jun 29, 2022
Start date
Jun 23, 2022
Primary completion
Oct 20, 2022
Completion
Nov 23, 2022
Last update
Jan 4, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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