Psychological and Physiological Parameters for Return-to-sport After ACL Reconstruction

NCT07259083 | Completed

• 1 other identifier: Kepler Universitätsklinikum /
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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?

Conditions

ACL Reconstruction

Keywords

ACL rupture; ACL reconstruction; Return to sport; ACL tear; Dynamometry

Outcome Measures

Primary Outcomes (2)

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

  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.

  Day 1 (1 to 4 years after ACL reconstruction)

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

  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.

  Day 1 (1 to 4 years after ACL reconstruction)

Secondary Outcomes (2)

• Isokinetic dynamometry (Biodex System 4)

  Day 1 (1 to 4 years after ACL reconstruction)

• Sports activity

  Day 1

Other Outcomes (5)

• Time since ACL surgery

  Day 1

• Height

  Day 1

• Weight

  Day 1

Study Arms (1)

Participants after ACL reconstruction

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Physically active adults who underwent unilateral ACL reconstruction 1 to 4 years ago

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johannes Kepler University of Linz: lead
• University of Salzburg: collaborator

Study Sites (1)

Kepler University Clinic, Dept. of Physical Medicine & Rehabilitation

Linz, 4021, Austria

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: December 2, 2025
• Study Start: April 16, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 30, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)