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临床试验/NCT04593264
NCT04593264已完成不适用

Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears

WellSpan Health2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Number of Participants Ready for ACL repair surgery

研究概览

简要总结

Although the success of physical therapy following surgery has been well-documented and validated in patients undergoing Anterior Cruciate Ligament Reconstruction (ACLR) procedures, more recent studies have demonstrated that patient outcomes are the most favorable when surgery is delayed approximately 4 weeks until after the patient has completed a preoperative physical therapy program, or "pre-habilitation." The ultimate goal of pre-habilitation is to regain full range of motion in the knee and reach approximately 80% of pre-injury quadricep strength. However, extra physical therapy can stress both time and resources. Thus, we propose a home-based, self-guided pre-habilitation program. We hypothesize that patients participating in self-guided pre-habilitation will experience the same benefits as patients in a traditional office-based physical therapy program.

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
13 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Skeletal maturity
  • Acute ACL rupture occurring no longer than 4 weeks prior to presentation
  • Ability to participate in a pre-habilitation program
  • Nature of the injury allows adequate time for pre-habilitation
  • Ability to speak, read, and understand English
  • Willing and able to provide informed consent

排除标准

  • Any injuries requiring immediate surgical intervention
  • Ipsilateral meniscus tear that preventing participation in a pre-habilitation program
  • Ipsilateral MCL tears grade III
  • Ipsilateral PCL tears (any grade)
  • Concomitant LCL injuries
  • Concomitant posterolateral corner injuries
  • Inflammatory arthritis
  • Prior ACL rupture/reconstruction
  • Anyone unable to participate in a stretching/strengthening program

结局指标

主要结局

Number of Participants Ready for ACL repair surgery

时间窗: Approximately 4 weeks following initiation of a pre-habilitation program

The surgeon will decide if the patient's knee is optimized and ready for surgery based on quadricep circumference and range of motion.

次要结局

  • Thigh circumference(Approximately 4 weeks following initiation of a pre-habilitation program)
  • Knee Range of Motion(Approximately 4 weeks following initiation of a pre-habilitation program)

研究者

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

John Deitch

Principal Investigator

WellSpan Health

研究点 (2)

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