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临床试验/NCT05436210
NCT05436210已完成不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
north star ambulation assessment

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

north star ambulation assessment

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Güllü AYDIN YAĞCIOĞLU

Principal Investigator

Hacettepe University

研究点 (1)

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