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

NCT06748066 | Active Not Recruiting

• 1 other identifier: RISE-ACL
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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 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.

Conditions

ACL Surgery; ACL Injuries; ACL Reconstruction

Keywords

Postoperative Care; Return to Sport; Risk-Taking; Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)

  One measurement during one visit at 4 to 24 months after surgery

• Individual - age

  One measurement during one visit at 4 to 24 months after surgery

• Strength

  One measurement during one visit at 4 to 24 months after surgery

• Surgery characteristics

  One measurement during one visit at 4 to 24 months after surgery

• IKDC Subjective Knee Evaluation

  One measurement during one visit at 4 to 24 months after surgery

Study Arms (2)

Group of experts in the field of ACL reconstruction surgery and follow-up

EXPERIMENTAL

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

ACL - reconstruction group, scale validation

EXPERIMENTAL

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

Interventions

RISE-ACL development BEHAVIORAL

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).

Group of experts in the field of ACL reconstruction surgery and follow-up

RISE-ACL scale validation BEHAVIORAL

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.

ACL - reconstruction group, scale validation

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead
• INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie: collaborator

Study Sites (1)

CHU Caen Normandy

Caen, Basse-Normandie, 14000, France

Location

Related Publications (1)

• Labrousse A, Reboursiere E, Remilly M, Roulland R, Mergenthaler G, Hulet C, Drigny J. Development and validation of a scale to assess risk-taking intentions during return to sport following anterior cruciate ligament reconstruction. J ISAKOS. 2025 Dec 18:101052. doi: 10.1016/j.jisako.2025.101052. Online ahead of print.

  PMID: 41421604 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Risk-Taking

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maître de conférences des universités - praticien hospitalier (MCU-PH), M.D, Ph.D

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: February 3, 2025
• Primary Completion: July 29, 2025
• Study Completion: March 31, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

FR (1)