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Clinical Trials/NCT05436210
NCT05436210
Completed
Not Applicable

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

Hacettepe University1 site in 1 country48 target enrollmentJune 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Duchenne Muscular Dystrophy
Sponsor
Hacettepe University
Enrollment
48
Locations
1
Primary Endpoint
north star ambulation assessment
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 23, 2022
End Date
November 23, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Güllü AYDIN YAĞCIOĞLU

Principal Investigator

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • 1.5 to 18 years old
  • Not to have lost his ambulation
  • 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.

Outcomes

Primary Outcomes

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

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.

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.

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.

Study Sites (1)

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