- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259083
Psychological and Physiological Parameters for Return-to-sport After ACL Reconstruction (ACL-RTS)
Long-term Correlation of Functional and Psychological Parameters for the Return-to-sport Decision After Anterior Cruciate Ligament Reconstruction
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Linz, Austria, 4021
- Kepler University Clinic, Dept. of Physical Medicine & Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
- Fever
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Participants after ACL reconstruction
1 to 4 years after ACL reconstruction, age: 18 - 50 years, physically active
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Peak torque (Nm) - Isokinetic dynamometry (Biodex System 4)
Time Frame: Day 1 (1 to 4 years after ACL reconstruction)
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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)
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ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)
Time Frame: Day 1 (1 to 4 years after ACL reconstruction)
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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.
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Day 1 (1 to 4 years after ACL reconstruction)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Isokinetic dynamometry (Biodex System 4)
Time Frame: Day 1 (1 to 4 years after ACL reconstruction)
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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. |
Day 1 (1 to 4 years after ACL reconstruction)
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Sports activity
Time Frame: Day 1
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Sports activity before and after surgery in minutes/week
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Day 1
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time since ACL surgery
Time Frame: Day 1
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Time in months since ACL surgery
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Day 1
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Height
Time Frame: Day 1
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Height of the participant in cm
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Day 1
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Weight
Time Frame: Day 1
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Weight of the participant in kg
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Day 1
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Body Mass Index
Time Frame: Day 1 (1 to 4 years after ACL reconstruction)
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Relation of body weight to the square of body height
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Day 1 (1 to 4 years after ACL reconstruction)
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Age
Time Frame: Day 1
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Age of the participant in years
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Day 1
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kepler Universitätsklinikum /
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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