Validation of the Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer Against a Reference Isokinetic Dynamometer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Intra-class correlation coefficient of the inversion force (or supination measured in Newton) of the foot between the measurement made with the hand dynamometer and the measurement made with the isokinetic dynamometer (gold standard).
研究概览
简要总结
Adult flat foot valgus is a degenerative pathology that causes damage to the ligaments of the hindfoot as well as dysfunction of the tendon of the posterior tibial muscle.
Currently, there is a lack of a tool allowing a standardized, reliable, reproducible and validated measurement of the strength of the tendon of the posterior tibial muscle in consultation of foot surgery.
The hand-held dynamometer could be that tool. The study would consist in measuring the strength of the tendon of the posterior tibial muscle in healthy subjects with a hand-held dynamometer (MicroFET2) by two examiners and compared to isometric reference measurements (CON-TREX CMV Multi-Joint) to validate the reliability of the measurement and its reproducibility.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from physical medicine and rehabilitation department hospitalized for pathologies other than neurological or osteo-articular pathologies affecting the lower limbs,
- •Having no neurological or osteo-articular pathology affecting the lower limbs f one year,
- •No history of surgery on the rear foot and ankle,
- •Written informed consent from person,
- •Socially insured patient person,
- •Person willing to comply with all study procedures and study duration.
排除标准
- •Neurological or osteo-articular pathologies affecting the lower limbs,
- •Known pathologies of the tendon of the posterior tibialis muscle,
- •Deformations of the foot (flat foot, hollow foot),
- •History of hindfoot or ankle surgery,
- •Pregnant or breastfeeding woman,
- •Inability to receive information, consent and participate in the whole study,
- •Person under judicial protection or deprived of liberty,
- •Person participating in another clinical trial,
- •No social insurance cover,
- •No written consent.
结局指标
主要结局
Intra-class correlation coefficient of the inversion force (or supination measured in Newton) of the foot between the measurement made with the hand dynamometer and the measurement made with the isokinetic dynamometer (gold standard).
时间窗: on the day of first evaluation (at day 1)
Validity of the measurement of the tendon strength of the posterior tibial muscle with a hand-held dynamometer (MicroFET2) compared to the gold standard (CON-TREX CMV Multi-Joint) in subjects.
次要结局
- Intra-class correlation coefficient of the inversion force of the foot between two measurements made by the same observer with the hand dynamometer (intra-observer reproducibility).(on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2))
- Intra-class correlation coefficient of the inversion force of the foot between measurements made by two different observers with the hand dynamometer (intra-observer reproducibility).(on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2))