A Single Center Pilot Study to Assess the Intra-observer Reliability of Measuring Muscle Strength Using a Hand Held Dynamometer in Children and Adults With Neurofibromatosis Type 1 (NF1) and Type 2 (NF2).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Intra-class correlation coefficient of strength measurement in the clinically identified weak muscle
研究概览
简要总结
Patients with clinically confirmed neurofibromatosis type 1 (NF1) or neurofibromatosis type 2 (NF2) or a known neurofibromatosis (NF) mutation aged 5 years and above will be eligible to participate and will be recruited from the neurofibromatosis clinic. Given the need for identifying measures that can reliably and sensitively measure focal muscle weakness and allow for measuring muscle strength as a functional outcome in therapeutic clinical trials in NF, this pilot study will assess the reliability of measuring muscle strength in NF1 and NF2 using a hand-held dynamometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For cohort 1:
- •Patients must have clinically confirmed NF1 using the NIH consensus criteria or a known NF1 mutation
- •Ages 5 years and above
- •< 5/5 strength on Manual Muscle Testing (MMT) testing in at least one muscle group tested on the day of enrollment
- •Able to follow instructions and cooperate with exam to assess strength
- •For Cohort 2
- •Patients must have clinically (NIH or Manchester criteria) or genetically confirmed diagnosis of NF2
- •Ages 5 years and above
- •< 5/5 strength on MMT testing in at least one muscle group tested on the day of enrollment
- •Able to follow instructions and cooperate with exam to assess strength
排除标准
- •No orthopedic procedure or other major surgery that could influence extremity strength in past 6 months
- •No tibial dysplasia
结局指标
主要结局
Intra-class correlation coefficient of strength measurement in the clinically identified weak muscle
时间窗: 1 day
A sample size of 20 subjects with three observations per subject achieves 90% power to detect an intraclass correlation of 0.91 under the alternative hypothesis when the intraclass correlation under the null hypothesis is 0.75 using an F-test with a significance level of 0.05.
次要结局
- standard error of measurement of measuring strength in the weak muscles(1 day)
- Intra-class correlation coefficient of strength measurement in the dominant biceps(1 day)
- standard error of measurement of measuring strength in the dominant biceps muscle(1 day)