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Not yet recruitingNCT07659613NEURO-K-STARTSUpdated Jun 22, 2026

Assessment of NEURO-K-STARTS Following Primary Anterior Cruciate Ligament (ACL) Reconstruction

An interventional study of NEURO-K-STARTS in ACL - Anterior Cruciate Ligament Rupture, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the detailed description

Anterior cruciate ligament (ACL) injuries are debilitating for both professional and amateur athletes, with long-term implications for performance and return to sport (RTS).

ACL reconstruction is the primary treatment option. Despite this, recurrence rates are high. Half of all recurrences occur within 8 months of reconstruction, and 70% within the first 6 months after RTS. The decision to return to sport 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. It is with this in mind that the K-STARTS (Knee Safety Athletic Return to Sport) was developed. It is a composite test comprising scored 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. It consists of 7 tests scored out of 100 points:

  • A psychological test: the ACL-RSI.
  • Six athletic tests: Single Leg Landing (landing on one leg: dynamic valgus), Single Hop Test (single jump), Triple Hop Test (triple jump), Side Hop Test (side jumps), Crossover Hop Test (crossover jumps), Modified Illinois Test

Currently, functional tests are limited to measuring physical performance, yet athletes often multitask, divide their attention and 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 a return to sport. 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.

The four individual neurofunctional tests that make up the NEURO-K-STARTS have been shown to be reliable in healthy subjects, but no evaluation of the NEURO-K-STARTS in patients undergoing primary ACL reconstruction has been published. This is why this research is set up.

02

Conditions studied

  • ACL - Anterior Cruciate Ligament Rupture

Keywords

  • K-STARTS
  • NEURO-K-STARTS
  • ACL rupture
03

In context

Anterior Cruciate Ligament Injuries

512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.

This study's planned enrollment of 144 is above the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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 BMI \< 18.5 or > 30
  • Subject who is professional athlete
  • Subject with severe associated conditions (neurological, connective tissue disorders, congenital diseases)
  • Subject with colour blindness
  • Subject with multi-ligament deficiency or associated osteotomy
  • Subject enrolled in another study whose procedures may interfere with this study
  • Subject under legal protection: adults under guardianship, curatorship or other legal protection, or deprived of their liberty by judicial or administrative decision
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Active comparator
    Healthy Arm

    Healthy volunteers without ACL rupture

    Behavioral: NEURO-K-STARTS

  • Experimental
    ACL Arm

    Patients with ACL rupture

    Behavioral: NEURO-K-STARTS

Interventions

  • BehavioralNEURO-K-STARTS

    NEURO-K-STARTS involves carrying out the three standard horizontal jump tests from the K-STARTS (Single Hop Test, Triple Hop Test and Crossover Hop Test), supplemented by four neurofunctional tests. It is the combination of these tests that makes up the NEURO-K-STARTS

06

What researchers measure

Primary outcomes

  1. Cognitive Influence Index

    CII value is calculated for each neurofunctional test. This is the ratio of the performance achieved (Limb Symmetry Index; LSI) in the neuro version to that in the standard version of a given test.

    Time frame: Day 0

07

Study locations

1 site
  • Hôpital Privé Jean Mermoz
    Lyon, 69008, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07659613
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Sep 2026 (estimated)
Primary completion
Feb 2029 (estimated)
Completion
Feb 2029 (estimated)
Last update
Jun 22, 2026

Study contacts

Bertrand SONNERY-COTTET, MD
Contact
sonnerycottet@aol.com
+ 33 4 37 53 00 22

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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