An interventional study of RISE-ACL development and RISE-ACL scale validation in ACL Surgery, ACL Injuries and ACL Reconstruction, sponsored by University Hospital, Caen. Active, not recruiting at 1 site in France. Open to participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Diagnostic
Psychological factors play a critical role in recovery following anterior cruciate ligament (ACL) reconstruction. While tools such as the ACL - Return to Sport after Injury (ACL-RSI) focus on psychological readiness, emphasizing fear, hesitation, and apprehension, the opposite spectrum-overconfidence and risk-taking behaviors-remains underexplored. These behaviors can lead to premature return to high-risk activities and an increased likelihood of re-injury.
To address this gap, we propose the development and validation of the RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction. This scale will assess key factors such as patients' willingness to engage in high-impact activities, their adherence to medical guidance, and their perceived readiness to resume sports despite potential physical or psychological limitations.
The RISE-ACL Scale will complement existing tools like the ACL-RSI by focusing on overconfidence and risk-taking, offering clinicians a more balanced perspective on psychological recovery. Validation of the scale will involve testing its validity, reliability and clinical utility to ensure accurate identification of at-risk individuals.
By providing actionable insights, the RISE-ACL Scale will help enhance post-operative care, promote safer return-to-play decisions, and optimize long-term outcomes through a comprehensive assessment of psychological and behavioral factors.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's enrollment of 162 is above the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A group of 11 experts in the field of ACL reconstruction, each with a minimum of five years of experience and at least 100 patients managed, will collaborate to select the items to be included in the RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction.
Behavioral: RISE-ACL development
162 patients who have undergone ACL reconstruction within the past two years and are currently in the 'Return to Sport' process, with follow-up in the sports medicine department, will complete the RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction.
Behavioral: RISE-ACL scale validation
A meeting will be organized with all expert panel members to select relevant items. Before the meeting, experts will review a literature on ACL reconstruction return to sport processes. During round 1, the chairperson will ask panel members to suggest items to be included in the scale. Items with agreement from 5 or more members will be included in round 2. In round 2, redundant items will be identified and grouped, and new items will be added based on the literature and expert experience. Selected items will be randomly ordered to create a preliminary 6-level Likert scale (0 = strongly disagree, 5 = strongly agree).
The scale validation phase will involve 162 participants who have undergone ACL reconstruction within the past two years and are in the 'Return to Sport' process, with follow-up in the sports medicine department. These participants will complete the final version of the RISE-ACL Scale in addition with the ACL-RSI scale and the IKDC Subjective Knee Form. Validation will consist of testing face validity, construct validity, criterion validity (concurrent validity), and reliability, including internal consistency and test-retest reliability.
The RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction.
The RISE-ACL Scale will measure patients' risk-taking tendencies, overconfidence in their recovery, and willingness to resume sports despite physical or psychological limitations. The number and nature of the items will be defined during the development phase. The scale will be scored on a Likert scale ranging from 0 to 3, with 0 representing "strongly disagree" and 3 representing "strongly agree."
Time frame: One measurement during one visit at 4 to 24 months after surgery
ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)
The ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each
Time frame: One measurement during one visit at 4 to 24 months after surgery
Individual - age
Personal characteristics recorded in the medical report as age
Time frame: One measurement during one visit at 4 to 24 months after surgery
Strength
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer, part of the current Return-to-sport process
Time frame: One measurement during one visit at 4 to 24 months after surgery
Surgery characteristics
Surgery characteristics recorded in the medical report as the type of surgery,
Time frame: One measurement during one visit at 4 to 24 months after surgery
IKDC Subjective Knee Evaluation
The IKDC Subjective Knee Evaluation Form is scored by summing the individual item scores and converting the total to a scale of 0 to 100. Higher scores reflect better function and fewer symptoms, with the final score indicating overall knee function.
Time frame: One measurement during one visit at 4 to 24 months after surgery
RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction for test-retest reliability
A smaller sample of 28 participants will complete the scale twice, with a 5-day interval, to test its reproducibility. Scoring and minimum-maximum values will be defined at the development stage
Time frame: Two measurements at a 5-day interval
Individual characteristics - gender
Personal characteristics recorded in the medical report as gender
Time frame: One measurement during one visit at 4 to 24 months after surgery
Individual characteristics - sport
Personal characteristics recorded in the medical report as type of sport with sport level of practice
Time frame: One measurement during one visit at 4 to 24 months after surgery
Individual characteristics - return to sport
Personal characteristics recorded in the medical report as return to sport after the surgery
Time frame: One measurement during one visit at 4 to 24 months after surgery
Plan to share: Undecided
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Anterior Cruciate Ligament Injuries →