Developing and Validating the Risk-taking Intention and Sport Engagement After ACL Reconstruction (RISE-ACL) Scale
NCT ID: NCT06748066
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
162 participants
INTERVENTIONAL
2025-02-03
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport
NCT05323474
Effect of Patient Resilience on Return to Sport Post ACL Reconstruction Surgery
NCT03013231
Psychological and Physiological Parameters for Return-to-sport After ACL Reconstruction
NCT07259083
Association Between Neuromuscular Parameters and Functional Assessment After ACL Reconstruction
NCT06524869
Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament
NCT06050005
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group of experts in the field of ACL reconstruction surgery and follow-up
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.
RISE-ACL development
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).
ACL - reconstruction group, scale validation
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.
RISE-ACL scale validation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RISE-ACL development
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).
RISE-ACL scale validation
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient included in the sport medicine follow-up protocole
* Patients who have provided informed consent.
Exclusion Criteria
16 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie
UNKNOWN
University Hospital, Caen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joffrey DRIGNY
Maître de conférences des universités - praticien hospitalier (MCU-PH), M.D, Ph.D
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Caen Normandy
Caen, Basse-Normandie, France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RISE-ACL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.