跳至主要内容
临床试验/NCT05488054
NCT05488054招募中不适用

Use of a Wearable Muscle Oxygen Saturation Sensor in the Rehabilitation of High-School and Collegiate Athletes Recovering From Arthroscopic Hip and Knee Surgery

University Hospitals Cleveland Medical Center4 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2022年8月8日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

James E Voos, MD

Chairman, Department of Orthopaedic Surgery

University Hospitals Cleveland Medical Center

研究点 (4)

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