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