Clinical trial NCT06748066: Developing and Validating the Simple Measure of Attitudes and Risk-Taking After ACL Reconstruction (SMART-ACL) Scale
Official title: Development and Validation of the SMART-ACL Scale for Assessing Risk-Taking and Overconfidence After ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ACL Surgery
ACL Injuries
ACL Reconstruction
Keywords: Postoperative Care
Return to Sport
Risk-Taking
Anterior Cruciate Ligament Injuries
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie
First posted: 2024-12-24
Enrollment: 84
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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 SMART-ACL scale: a Simple Measure of Attitudes and Risk-Taking 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 SMART-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 SMART-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.


Eligibility criteria: Inclusion Criteria:

* Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery)
* Patient included in the sport medicine follow-up protocole
* Patients who have provided informed consent.

Exclusion Criteria:

* Participants who are not included in the Return-to-sport process

Primary outcomes:
measure: The SMART-ACL scale: Simple Measure of Attitudes and Risk-Taking after ACL Reconstruction
timeFrame: One measurement during one visit at 4 to 24 months after surgery
Secondary outcomes:
measure: ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)
timeFrame: One measurement during one visit at 4 to 24 months after surgery
measure: Individual - age
timeFrame: One measurement during one visit at 4 to 24 months after surgery
measure: Strength
timeFrame: One measurement during one visit at 4 to 24 months after surgery
measure: Surgery characteristics
timeFrame: One measurement during one visit at 4 to 24 months after surgery
measure: IKDC Subjective Knee Evaluation
timeFrame: One measurement during one visit at 4 to 24 months after surgery
measure: SMART-ACL (Simple Measure of Attitudes and Risk-Taking after ACL Reconstruction) scale for test-retest reliability
timeFrame: Two measurements at a 5-day interval
measure: Individual characteristics - gender
timeFrame: One measurement during one visit at 4 to 24 months after surgery
measure: Individual characteristics - sport
timeFrame: One measurement during one visit at 4 to 24 months after surgery
measure: Individual characteristics - return to sport
timeFrame: One measurement during one visit at 4 to 24 months after surgery
Other outcomes:
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