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ACL ReconstructionACL-RTSNCT07259083

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

An observational study of ACL Reconstruction, run by Johannes Kepler University of Linz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
ACL Reconstruction
How many people
30 participants
Where
1 siteAustria
Study dates
16 Apr 2025to 30 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Kepler University Clinic, Dept. of Physical Medicine & Rehabilitation

    Linz, 4021

Other trials in Austria

About this study

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

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?

Keywords
ACL rupture, ACL reconstruction, Return to sport, ACL tear, Dynamometry
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07259083
Study groupRoleWhat they receive
Participants after ACL reconstruction1 to 4 years after ACL reconstruction, age: 18 - 50 years, physically active

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1 (1 to 4 years after ACL reconstruction)

  2. 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.

    Measured: Day 1 (1 to 4 years after ACL reconstruction)

Secondary outcomes (2)

  1. Isokinetic dynamometry (Biodex System 4)

    The isokinetic dynamometer measures concentric strength in extension and flexion including following parameters:

    Average peak torque (Nm), time to peak torque (sec), angle of peak torque (deg), torque at 30°, torque at 0.18 seconds, max. repetitions to total work, work/body weight, total work, work first third, work last third, work fatique, avg. power, acceleration time (msec), ROM (range of motion, deg), agonist/antagonist ratio (%), hamstring/quadriceps (H/Q) ratio, LSI (limb symmetry index)

    Isokinetic strength testing at a ROM of 0-90° knee flexion at 3 different speeds. Test protocol at angular velocities of 60°/sec, 180°/sec and 240°/sec.

    Measured: Day 1 (1 to 4 years after ACL reconstruction)

  2. Sports activity

    Sports activity before and after surgery in minutes/week

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start16 Apr 2025
  3. Primary completion1 Sep 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07259083
Sponsor's protocol ID
Kepler Universitätsklinikum /
Acronym
ACL-RTS
Status last verified
Apr 2026
First submitted
16 Apr 2025
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of ACL Reconstruction, run by Johannes Kepler University of Linz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak torque (Nm) - Isokinetic dynamometry (Biodex System 4) (time frame: Day 1 (1 to 4 years after ACL reconstruction)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07259083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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