Developing and Validating the Risk-taking Intention and Sport Engagement After ACL Reconstruction (RISE-ACL) Scale (RISE-ACL)

Development and Validation of the RISE-ACL Scale for Assessing Risk-Taking Intension and Propensity After ACL Reconstruction

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ACL Reconstruction; ACL Injuries; ACL Surgery
• Intervention / Treatment: Behavioral: RISE-ACL development; Behavioral: RISE-ACL scale validation

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Basse-Normandie
    • Caen, Basse-Normandie, France, 14000
      • CHU Caen Normandy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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).
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	One measurement during one visit at 4 to 24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One measurement during one visit at 4 to 24 months after surgery
Individual - age	Personal characteristics recorded in the medical report as age	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	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,	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.	One measurement during one visit at 4 to 24 months after surgery
Individual characteristics - gender	Personal characteristics recorded in the medical report as gender	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	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	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	Two measurements at a 5-day interval

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Actual): July 29, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Anterior Cruciate Ligament Injuries; Postoperative Care; Return to Sport; Risk-Taking
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Bone Density Conservation Agents; Membrane Transport Modulators; Calcium Channel Blockers; Risedronic Acid
• Other Study ID Numbers: RISE-ACL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No