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临床试验/NCT02146586
NCT02146586Unknown不适用

Cooperative International Neuromuscular Research Group (CINRG) Clinical Evaluator Outcomes Reliability Study

Cooperative International Neuromuscular Research Group0 个研究点目标入组 55 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
55
主要终点
Clinical Evaluator Assessments

研究概览

简要总结

This study outlines structured Clinical Evaluator (CE) testing techniques that are proposed to be implemented across all sites participating in the Cooperative International Neuromuscular Research Group (CINRG) research studies. The study will determine if the selected techniques are reliable and reproducible across the CINRG network by evaluating the reliability and reproducibility of the measures between CEs

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
6 Years 至 —(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Site confirmed genetic diagnosis of a dystrophinopathy
  • Aged 6 years and older
  • Able to transfer to testing table
  • Able to walk 10 meters without an assistive device
  • Dystrophinopathy Participant

排除标准

  • Investigator assessment of inability to comply with protocol assessments
  • Participants who have attention deficient disorder or other cognitive conditions that may limit attention span to perform protocol assessments

结局指标

主要结局

Clinical Evaluator Assessments

时间窗: One time visit

The following assessments are conducted by certified physical therapists: Anthropometrics, goniometry, Brooke upper extremity and Vignos lower extremity scales, Performance Upper Limb Scale (PULS), North Star Ambulatory Assessment (NSAA), Six Minute Walk Test (6MWT), time to rise from floor, time to stand from a chair, time to climb four stairs, time to walk/run 10 meters, 9 Hole Peg Test (9HPT), Quantitative Muscle Tests (QMT), Manual Muscle testing (MMT), Force Vital Capacity (FVC), Force Expiratory Volume (FEV1), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), Peak Expiratory Flow Rate (PEFR) and Peak Cough Flow (PCF). The reliability of these commonly used measurements is fundamental to clinical research, our ability to have confidence in the data we collect and our ability to draw rational conclusions from the data.

次要结局

未报告次要终点

研究者

发起方
Cooperative International Neuromuscular Research Group
申办方类型
Network
责任方
Sponsor

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