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临床试验/NCT07259083
NCT07259083已完成不适用

Long-term Correlation of Functional and Psychological Parameters for the Return-to-sport Decision After Anterior Cruciate Ligament Reconstruction

Johannes Kepler University of Linz2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月16日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Peak torque (Nm) - Isokinetic dynamometry (Biodex System 4)

研究概览

简要总结

Injuries to the anterior cruciate ligament are common and are usually treated with reconstruction and subsequent rehabilitation. Many people succeed in return to sport (RTS), but not to the original level. Muscle strength factors can be assessed using isokinetic strength measurements, while the psychological readiness to return to sport can be assessed using the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) questionnaire. In this study, isokinetic strength testing and psychological testing with the ACL-RSI questionnaire 1 to 4 years after ACL reconstruction will be assessed. The study will be conducted at the Institute of Physical Medicine & Rehabilitation at the Kepler University Hospital. The Biodex System Pro™, a medical device for measuring and training muscle strength, will be used for the isokinetic measurements. The research question is as follows: Is there a correlation between the results of the ACL RSI questionnaire and the results of isokinetic strength testing on the Biodex System 4 Pro™ in test subjects following ACL reconstruction?

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Primary unilateral ACL reconstruction 1 to 4 years prior testing
  • Physically active
  • 18-50 years
  • Medical approval for maximum loads

排除标准

  • Bilateral Knee injury
  • Pregnancy
  • Acute pain (VAS ≥ 3)
  • Extremely limited mobility
  • Extreme joint instability
  • Acute injuries
  • Inflammation

研究组 & 干预措施

Participants after ACL reconstruction

1 to 4 years after ACL reconstruction, age: 18 - 50 years, physically active

结局指标

主要结局

Peak torque (Nm) - Isokinetic dynamometry (Biodex System 4)

时间窗: Day 1 (1 to 4 years after ACL reconstruction)

The isokinetic dynamometer measures concentric strength in extension and flexion. Isokinetic strength testing at a ROM (range of motion) of 0-90° knee flexion at 3 different speeds. Test protocol at angular velocities of 60°/sec, 180°/sec and 240°/sec.

ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)

时间窗: Day 1 (1 to 4 years after ACL reconstruction)

The ACL-RSI is a measure of psychological readiness to return to sport. It contains 12 questions and examines 3 components related to readiness to return to sport: emotions (5 questions), confidence in one's own performance (5 questions) and risk assessment (2 questions). The questions relate to the psychological effects of returning to sport. The respondents answer each question by giving their assessment in steps of ten on a Likert scale from 0 to 100 points. Low scores indicate a negative psychological assessment and high scores indicate a positive psychological assessment. The cut-off value for distinguishing between returnees and non-returnees is 51.3 points. A German version of the questionnaire is used.

次要结局

  • Isokinetic dynamometry (Biodex System 4)(Day 1 (1 to 4 years after ACL reconstruction))
  • Sports activity(Day 1)

研究者

发起方
Johannes Kepler University of Linz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Mittermaier

M.D.

Johannes Kepler University of Linz

研究点 (2)

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