Assessment of NEURO-K-STARTS Following Primary Anterior Cruciate Ligament (ACL) Reconstruction (NCT07659613) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessment of NEURO-K-STARTS Following Primary Anterior Cruciate Ligament (ACL) Reconstruction
France144 participantsStarted 2026-09
Plain-language summary
Anterior cruciate ligament (ACL) reconstruction is the major treatment option for ACL injuries. Despite this, recurrence rates are high. Half of all recurrences occur within 8 months of reconstruction, and 70% within the first 6 months after return to sport (RTS). The decision to RTS is therefore a critical one, as returning too early can increase the risk of recurrence, whilst a delayed return delays a return to pre-injury performance levels.
To guide this decision-making process, objective data is required to determine fitness for RTS. This is why the K-STARTS (Knee Safety Athletic Return to Sport) was developed. It is a composite test comprising functional and psychological assessments that enable the calculation of an overall score used to determine the functional recovery of the knee six months after ACL reconstruction.
Currently, functional tests are limited to measuring physical performance, whereas athletes often manage complex visuospatial processing whilst performing physically. It is therefore necessary to develop clinical tests that integrate neurocognitive and physical functions in order to better simulate the sporting challenges that lead to injury and thus improve preparation for RTS NEURO-K-STARTS is a battery of functional tests based on three standard horizontal jump tests from the K-STARTS, supplemented by four neurofunctional tests.
No evaluation of the NEURO-K-STARTS in patients undergoing primary ACL reconstruction has been published. This is why this research is set up.
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (patients):
* Patient who has undergone primary ACL reconstruction at least 6 months ago
* Patient who has undergone an isokinetic strength test, the results of which do not indicate any contraindications to performing a functional test
* Patient who has resumed performing horizontal jumps under the supervision of a healthcare professional
* Patient with no history of surgery on the joints of the contralateral leg
* Patient enrolled in or covered by a social security scheme
* French-speaking patient who has signed an informed consent form
Exclusion Criteria (patients):
* Patient with a history of ligament surgery on the affected or contralateral knee
* Patient with a BMI \< 18.5 or \> 30
* Patient who is professional athlete
* Patient with severe associated conditions (neurological, connective tissue disorders, congenital diseases)
* Patient with colour blindness
* Patient with multi-ligament injury or associated osteotomy
* Patient enrolled in another study whose procedures may interfere with this study
* Protected patient: adults under guardianship, curatorship or other legal protection, or deprived of their liberty by judicial or administrative decision
Inclusion Criteria (healthy volunteers):
* Subject with no history of surgery on the joints of either leg
* Subject who is member of or beneficiary of a social security scheme
* French-speaking subject who has signed an informed consent form
Exclusion Criteria (healthy volunteers):
* Subject with a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive Influence Index
Timeframe: Day 0
Trial details
NCT IDNCT07659613
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche