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

Duchenne Muscular Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05436210
• Other study ID #: GO 22/414
• Status: Completed
• Start date: June 23, 2022
• Est. completion date: November 23, 2022

Study information

• Verified date: January 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 23, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years to 18 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Ambulation Difficulty
• Disease
• Duchenne Muscular Dystrophy
• Gait Disorders, Neurologic
• Mobility Limitation
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Nervous System Diseases
• Posture Disorders in Children

Intervention

Other:
• foot 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

Locations

Country	Name	City	State
Turkey	Güllü Aydin Yagcioglu	Isparta

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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