ACL SurgeryRISE-ACLNCT06748066
Developing and Validating the Risk-taking Intention and Sport Engagement After ACL Reconstruction (RISE-ACL) Scale
A study testing RISE-ACL development and RISE-ACL scale validation in people with ACL Surgery and ACL Injuries, run by University Hospital, Caen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- ACL Surgery, ACL Injuries, ACL Reconstruction
- What is being tested?
- RISE-ACL development and RISE-ACL scale validation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Participants who are not included in the Return-to-sport process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- RISE-ACL development, RISE-ACL scale validation
- Keywords
- Postoperative Care, Return to Sport, Risk-Taking, Anterior Cruciate Ligament Injuries
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISE-ACL developmentBehavioural
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 validationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: RISE-ACL scale validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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)
The ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each
Measured: One measurement during one visit at 4 to 24 months after surgery
Individual - age
Personal characteristics recorded in the medical report as age
Measured: 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
Measured: 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,
Measured: 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.
Measured: 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
Measured: Two measurements at a 5-day interval
Individual characteristics - gender
Personal characteristics recorded in the medical report as gender
Measured: 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
Measured: 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
Measured: One measurement during one visit at 4 to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start3 Feb 2025
- Primary completion29 Jul 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joffrey DRIGNY, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748066
- Sponsor's protocol ID
- RISE-ACL
- Acronym
- RISE-ACL
- Status last verified
- Jul 2025
- First submitted
- 18 Dec 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. 2026 Apr;17:101052. doi: 10.1016/j.jisako.2025.101052. Epub 2025 Dec 19.
PubMed 41421604
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the RISE-ACL Scale for Assessing Risk-Taking Intension and Propensity After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT06748066
- Acronym / sponsor ID
- RISE-ACL / RISE-ACL
- Conditions
- ACL Surgery, ACL Injuries, ACL Reconstruction
- Keywords
- Postoperative Care, Return to Sport, Risk-Taking, Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of experts in the field of ACL reconstruction surgery and follow-up | Experimental | Behavioral: RISE-ACL developmentA 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. |
| ACL - reconstruction group, scale validation | Experimental | Behavioral: RISE-ACL scale validation162 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. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who are not included in the Return-to-sport process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RISE-ACL developmentA 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). | Behavioural | Group of experts in the field of ACL reconstruction surgery and follow-up |
| RISE-ACL scale validationThe 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. | Behavioural | ACL - reconstruction group, scale validation |
Primary outcome
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."
9 secondary outcomes
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
Individual - age
Time frame: One measurement during one visit at 4 to 24 months after surgery
Strength
Time frame: One measurement during one visit at 4 to 24 months after surgery
Surgery characteristics
Time frame: One measurement during one visit at 4 to 24 months after surgery
IKDC Subjective Knee Evaluation
Time frame: 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
Time frame: Two measurements at a 5-day interval
Individual characteristics - gender
Time frame: One measurement during one visit at 4 to 24 months after surgery
Individual characteristics - sport
Time frame: One measurement during one visit at 4 to 24 months after surgery
Individual characteristics - return to sport
Time frame: One measurement during one visit at 4 to 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 41421604Labrousse 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. 2026 Apr;17:101052. doi: 10.1016/j.jisako.2025.101052. Epub 2025 Dec 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RISE-ACL development and RISE-ACL scale validation in people with ACL Surgery and ACL Injuries, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06748066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.