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临床试验/NCT05244395
NCT05244395已完成不适用

Development of a New Instrument to Evaluate Gait Characteristics of Individuals With Duchenne Muscular Dystrophy: Gait Assessment Scale for Duchenne Muscular Dystrophy, and Its Validity and Reliability

Hacettepe University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年2月10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
56
试验地点
2
主要终点
Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)

研究概览

简要总结

The aim of this study was to develop a gait assessment instrument for Duchenne Muscular Dystrophy patients (DMD-GAS), and investigate its validity and reliability.The scale was developed considering the expert opinions which included 10 physiotherapists who had experience in the management of patients with DMD over the 2-round Delphi method, and the Content Validity Index (CVI) was calculated. The final version of the DMD-GAS that was agreed upon the experts consisted of 10 items, and each item scored between 0 and 2. The intra-rater reliability was established by the video analysis of children with a 1-month interval and inter-rater reliability was determined by the scores of 3 physiotherapists. The criterion validity was determined by investigating the relationship between the total score of the DMD-GAS and Motor Function Measure (MFM), 6 Minute Walk Test (6MWT), and the data obtained from GAITRite system.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Being diagnosed with DMD
  • Be between Levels I-V according to Brooke Lower Limb Extremity Functional Classification
  • Being between the ages of 5-18
  • Agreeing to participate in the research voluntarily

排除标准

  • Insufficient cooperation with the physiotherapist,
  • Have had any injury and/or surgery of the lower extremities in the last 6 months,
  • Having neurological problems in addition to DMD. -

结局指标

主要结局

Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)

时间窗: 15-20 minutes

The scale which developed specifically for DMD with this study. The DMD-GAS was designed to consist of 10 items and each item scored as 0 (excessive compensation in the relevant body part), 1 (minimal compensation) or 2 (no compensation). Low score indicate compensated gait.

Motor Function Measure (MFM)

时间窗: 20-30 minutes

MFM, which was valid and reliable in Neuromuscular Diseases, was used for gross motor function assessment. The items in MFM, which evaluate functions in 3 different sections (D1, standing position and transfers; D2, axial and proximal motor function; D3, distal motor function) in 32 items in total, are scored between 0-3. 0; cannot initiate any movement and maintain the starting position, 1; partially completes the exercise, 2; performs the exercise slowly and visibly clumsily, with compensations, 3; performs the exercise in the specified standard pattern. High scores indicate higher motor function and the result is expressed as a percentage of the maximum possible score to enable comparison with other scores

次要结局

  • 6 meter walking test (6MWT)(6 minutes)

研究者

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

Güllü AYDIN YAĞCIOĞLU

Research Assistant

Hacettepe University

研究点 (2)

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