Use of a Wearable Muscle Oxygen Saturation Sensor in the Rehabilitation of High-School and Collegiate Athletes Recovering From Arthroscopic Hip and Knee Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 226
- 试验地点
- 4
- 主要终点
- Change in O2 Saturation levels as measured by Moxy Sensor device
研究概览
简要总结
This study will utilize the Moxy wearable sensor to measure muscle oxygen saturation levels in athletes following lower extremity surgery (ACL or Hip arthroscopy) to evaluate their Return-to-Play. The acquired data will complement current protocols utilized by Dr. Voos and Dr. Salata in this regard and will add quantifiable evidence to enable a robust measurement of the surgical limb versus non-surgical limb.
详细描述
Patients with a diagnosis of ACL tear or hip pathology will undergo surgery. Following surgery, patients will report to clinic for scheduled physical therapy per their institution's injury-specific physical therapy protocol. At set time points (6-week, 12-week, 6 months, and 9 months) during their recovery, patients will be assessed for muscle oxygen saturation and hemoglobin levels with the Moxy sensor. This sensor is a non-invasive device placed over the rectus femoris to monitor oxygen and hemoglobin levels. The patient will then follow the therapy as instructed by the physical therapist and perform the protocol-specific exercises with the sensor in place. The measured parameters will be recorded and stored per patient.
The injured patients will be compared to healthy control patients undergoing a similar one-hour exercise session while wearing the Moxy sensor for comparison of results.
The goal of this study is to use the data obtained from the Moxy sensor device to further predict recovery of function in muscles supporting injured soft tissues to determine safe return to sport.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range: Patients age 14 to 30 years
- •Patients with ACL injury requiring surgical correction
- •Patients undergoing arthroscopic hip surgery
- •Healthy individuals with no history of ACL, arthroscopic knee or arthroscopic hip surgery
排除标准
- •Patients below 14 years or above 30 years
- •Non-English-speaking subjects
- •Pregnant individuals
结局指标
主要结局
Change in O2 Saturation levels as measured by Moxy Sensor device
时间窗: 6 months, 9 months, 12 months (once for healthy individuals)
Changes in hemoglobin levels as measured by Moxy Sensor device
时间窗: 6 months, 9 months, 12 months (once for healthy individuals)
次要结局
未报告次要终点
研究者
James E Voos, MD
Chairman, Department of Orthopaedic Surgery
University Hospitals Cleveland Medical Center
