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临床试验/NCT07171346
NCT07171346Enrolling By Invitation不适用

Effects on Patient Outcomes With Post-Operative Use of Zynex Neuromuscular Electrical Stimulation (NMES): Zynex-25

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年2月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
25
试验地点
1
主要终点
Bilateral Muscle Symmetry Index

研究概览

简要总结

This study is being conducted to learn about how neuromuscular electrical stimulation (NMES) in addition to standard of care aids in the recovery of muscle strength in patients undergoing ACLR procedure.

详细描述

The addition of neuromuscular electrical stimulation (NMES) to standard ACLR rehabilitation has been demonstrated to improve knee extension and flexion compared to standard treatment only. NMES has also shown improved lower limb loading symmetry, walking velocity, stance time, cadence, maximum voluntary isometric contraction, motor unit behavior, muscle quality, and an increase in absolute muscle strength in functional tests compared to standard care of ACLR recovery. In this study we will be comparing bi-lateral presurgical and post surgical muscle strength symmetry in patients that follow the standard ACLR rehabilitation program and patients that use the NMES in addition to standard rehab.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ACLR surgical patients at KUMC sports medicine
  • 15 to 50 years old
  • BMI between 18 - 30 kg/m2
  • No limitations impacting physical function within the last 6 months (not including the ACL injury)

排除标准

  • Previous lower limb or spine injury involving surgical treatment
  • Prior spine surgery
  • Lower limb injury (other than ACL) preventing participation in physical activity for over two weeks in the past 6 months
  • Non english speaking
  • Vulnerable population, prisoner, or ward of the state

研究组 & 干预措施

NMES

Experimental

All participants will use the NMES device in addition to standard rehab protocol

干预措施: Zynex NexWave Electrotherapy Device (Device)

结局指标

主要结局

Bilateral Muscle Symmetry Index

时间窗: pre-operative to 3 months post-op

Comparing muscle size strength and function between operative and non-operative limbs

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

Scott Mullen

Associate Professor Orthopedic Surgery & Sports Medicine

University of Kansas Medical Center

研究点 (1)

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