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NCT Number: NCT06748066

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

ACL Surgery ACL Injuries ACL Reconstruction Anterior Cruciate Ligament Injuries Behavior Knee Injuries Leg Injuries Risk-Taking Wounds and Injuries

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Caen Normandy

Caen, Basse-Normandie, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. The RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction.

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

    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."

Secondary outcomes

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

    Time frame: 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

  2. Individual - age

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

    Personal characteristics recorded in the medical report as age

  3. Strength

    Time frame: 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

  4. Surgery characteristics

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

    Surgery characteristics recorded in the medical report as the type of surgery,

  5. IKDC Subjective Knee Evaluation

    Time frame: 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.

  6. RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction for test-retest reliability

    Time frame: Two measurements at a 5-day interval

    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

  7. Individual characteristics - gender

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

    Personal characteristics recorded in the medical report as gender

  8. Individual characteristics - sport

    Time frame: 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

  9. Individual characteristics - return to sport

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie

Registry information

Official study title

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

Acronym: RISE-ACL

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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