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临床试验/NCT03805464
NCT03805464招募中不适用

Characterizing Changes in Knee Joint Loading With Wearable Sensor Technology Following an Experimental Knee Joint Effusion

Duke University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
2
主要终点
Change in Peak Internal Knee Extension Moment

研究概览

简要总结

The purpose of this study is to determine the sensitivity of a wearable sensor to detect changes in knee joint loading using an experimental knee joint effusion as a model for a common clinical physiological alteration in joint status. The rationale for this project is that it will establish the efficacy of an inexpensive, clinically, and publicly available device that can detect changes in biomechanical loading due to acute physiologic change in joint status. The study will utilize a cross-sectional cohort study design and will seek to enroll 25 male and female healthy adult participants (18-35 yo). Participants will report to the laboratory for three total sessions (Session 1: informed consent and task familiarization; Session 2: testing; Session 3: knee joint status assessment). The primary outcomes of interest include lower extremity thigh and shank acceleration and velocity data (wearable sensor data), lower extermity 3D kinematics and kinetics (motion capture data), and lower extremity muscle function (EMG data) during walking gait, as well as functional balance and patient-reported subjective outcomes. Data will be analyzed by calculating change scores from the pre- to post-experimental effusion outcome measure testing. Paired-samples t-tests and Cohen's d effect sizes will be used to assess changed in wearable sensor data from pre- to post-experimental effusion. Correlation statistics will be used to determine if there are association between the motion capture and wearable sensor data. The potential risks associated with an experimental joint effusion will be addressed by maintaining appropriate sterile conditions and having the participant check-in with the PI (licensed healthcare provider) at 48 hours following testing session.

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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female
  • Chronological age 18-35 at the time of study participation
  • Physically active (at least 30 minutes of physical activity, 3x/week)
  • Tegner Activity Scale score at least 5/10

排除标准

  • History of lower extremity or lumbar spine surgery.
  • History of lower extremity or lumbar spine injury in the prior 6 months.
  • History of major ligamentous damage.
  • Current knee pain.
  • Known neurological condition, autoimmune condition, cardiovascular disease.
  • History of epilepsy, seizures, concussion within the prior 6 months.
  • Currently taking pain altering medication.
  • Fear of needles
  • Unable to read and understand English language
  • Pregnancy

结局指标

主要结局

Change in Peak Internal Knee Extension Moment

时间窗: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Kinetic Loading Variable

Change in Shank Angular Velocity

时间窗: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Gyroscope Variable

Change in Thigh Angular Velocity

时间窗: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Gyroscope Variable

Change in Peak Vertical Ground Reaction Force

时间窗: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Kinetic Loading Variable

Change in Peak Knee Power

时间窗: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Kinetic Loading Variable

Change in Thigh Acceleration

时间窗: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Accelerometer Variable

Change in Shank Acceleration

时间窗: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Accelerometer Variable

次要结局

  • Change in Hamstring EMG(Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion)
  • Change in Visual Analog Scale Pain(Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion)
  • Change in Quadriceps EMG(Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion)
  • Change in International Knee Documentation Committee(Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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