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临床试验/NCT07685561
NCT07685561尚未招募1 期

Restoration of Knee Extension After ACL Reconstruction: A Comparison of Standard Physical Therapy With and Without Adjunct Mechanical Stretching

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
入组人数
58
试验地点
1
主要终点
Changes in Knee Range of Motion

研究概览

简要总结

The purpose of this study is to determine whether the addition of a home-based high-intensity knee extension stretching device (Ermi Knee Extensionater) to standard postoperative physical therapy improves recovery of full knee extension following ACL reconstruction compared with standard physical therapy alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 14-65 yo
  • Primary ACLR (BTB auto ONLY)
  • Prior ACL tear treated non-op

排除标准

  • Revision ACL surgery
  • Major concomitant ligament reconstruction
  • Neurologic lower-extremity disorder
  • Inability to complete rehab
  • Cognitive impairment preventing consent

结局指标

主要结局

Changes in Knee Range of Motion

时间窗: Baseline, 2 weeks, 6 weeks, and 3 months

A goniometer will be used to measure the post operative knee's range of motion an angle or to rotate an object to a precise angular position.

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

Amit Momaya

Associate Professor

University of Alabama at Birmingham

研究点 (1)

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