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Clinical Trials/NCT07259083
NCT07259083
Completed
Not Applicable

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

Johannes Kepler University of Linz2 sites in 1 country30 target enrollmentStarted: April 16, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Johannes Kepler University of Linz
Enrollment
30
Locations
2
Primary Endpoint
Peak torque (Nm) - Isokinetic dynamometry (Biodex System 4)

Overview

Brief Summary

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?

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Participants after ACL reconstruction

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

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor
Johannes Kepler University of Linz
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christian Mittermaier

M.D.

Johannes Kepler University of Linz

Study Sites (2)

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