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