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

NCT07659613 | Not Yet Recruiting

• 1 other identifier: 2026-A00623-48
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ACL - Anterior Cruciate Ligament Rupture

Keywords

K-STARTS; NEURO-K-STARTS; ACL rupture

Outcome Measures

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.

  Day 0

Study Arms (2)

Healthy Arm

ACTIVE COMPARATOR

Healthy volunteers without ACL rupture

Behavioral: NEURO-K-STARTS

ACL Arm

EXPERIMENTAL

Patients with ACL rupture

Behavioral: NEURO-K-STARTS

Interventions

NEURO-K-STARTS BEHAVIORAL

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

ACL Arm; Healthy Arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Bertrand SONNERY-COTTET, MD

CONTACT

+ 33 4 37 53 00 22; sonnerycottet@aol.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)