Developing and Validating the Simple Measure of Attitudes and Risk-Taking After ACL Reconstruction (SMART-ACL) Scale

Not Applicable

Not yet recruiting

• Conditions: ACL Surgery; ACL Injuries; ACL Reconstruction

• Registration Number: NCT06748066
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study Start: 2025-02-03
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The SMART-ACL scale: Simple Measure of Attitudes and Risk-Taking after ACL Reconstruction	One measurement during one visit at 4 to 24 months after surgery	The SMART-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 5, with 0 representing "strongly disagree" and 5 representing "strongly agree."

Secondary Outcome Measures

Name	Time	Method
ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)	One measurement during one visit at 4 to 24 months after surgery	The ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each
Individual - age	One measurement during one visit at 4 to 24 months after surgery	Personal characteristics recorded in the medical report as age
Strength	One measurement during one visit at 4 to 24 months after surgery	Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer, part of the current Return-to-sport process
Surgery characteristics	One measurement during one visit at 4 to 24 months after surgery	Surgery characteristics recorded in the medical report as the type of surgery,
IKDC Subjective Knee Evaluation	One measurement during one visit at 4 to 24 months after surgery	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.
SMART-ACL (Simple Measure of Attitudes and Risk-Taking after ACL Reconstruction) scale for test-retest reliability	Two measurements at a 5-day interval	A smaller sample of 25 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
Individual characteristics - gender	One measurement during one visit at 4 to 24 months after surgery	Personal characteristics recorded in the medical report as gender
Individual characteristics - sport	One measurement during one visit at 4 to 24 months after surgery	Personal characteristics recorded in the medical report as type of sport with sport level of practice
Individual characteristics - return to sport	One measurement during one visit at 4 to 24 months after surgery	Personal characteristics recorded in the medical report as return to sport after the surgery