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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06748066
Acronym
RISE-ACL
Enrollment
162
Registered
2024-12-24
Start date
2025-02-03
Completion date
2026-03-31
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Injuries, ACL Reconstruction, ACL Surgery

Keywords

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

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.

Interventions

BEHAVIORALRISE-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).

BEHAVIORALRISE-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.

Sponsors

INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie
CollaboratorUNKNOWN
University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction.One measurement during one visit at 4 to 24 months after surgeryThe 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

MeasureTime frameDescription
Individual - ageOne measurement during one visit at 4 to 24 months after surgeryPersonal characteristics recorded in the medical report as age
StrengthOne measurement during one visit at 4 to 24 months after surgeryMeasurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer, part of the current Return-to-sport process
Surgery characteristicsOne measurement during one visit at 4 to 24 months after surgerySurgery characteristics recorded in the medical report as the type of surgery,
IKDC Subjective Knee EvaluationOne measurement during one visit at 4 to 24 months after surgeryThe 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.
ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)One measurement during one visit at 4 to 24 months after surgeryThe ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each
Individual characteristics - sportOne measurement during one visit at 4 to 24 months after surgeryPersonal characteristics recorded in the medical report as type of sport with sport level of practice
Individual characteristics - genderOne measurement during one visit at 4 to 24 months after surgeryPersonal characteristics recorded in the medical report as gender
Individual characteristics - return to sportOne measurement during one visit at 4 to 24 months after surgeryPersonal characteristics recorded in the medical report as return to sport after the surgery
RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction for test-retest reliabilityTwo measurements at a 5-day intervalA 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026