ACL InjuryKASTLABNCT06524869
Association Between Neuromuscular Parameters and Functional Assessment After ACL Reconstruction
An observational study of ACL Injury, run by University Hospital, Caen at 1 site in France.
Trial summary
The anterior cruciate ligament (ACL) injury is common in athletes aged 18 to 35. ACL reconstruction (ACLR) aims to restore knee stability in the process of returning to sports. Post-surgical rehabilitation focuses on optimizing biomechanical parameters, with neuromuscular and functional tests assessing muscle… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Isokinetic neuromuscular assessment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2024to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: All sports patients included in the sport medicine follow-up protocole with isokinetic muscular assessment at 6-12 months after ACL reconstruction surgery since March 2024 in the sports medicine department (Return To Sport Process)
Who may be able to join
- Adult patients, aged 18-40, who have undergone a first ACL reconstruction more than 6 months ago and are being followed in a sports medicine care pathway
- Affiliated with a health insurance plan
- Information form: Non-objection to the use of data for research purposes
Who cannot join
- Previous ligament surgery of the lower limbs prior to ACL reconstruction
- Complex ligament injury (lateral ligaments, posterior cruciate ligament)
- Recent muscle injuries
- History of injury to the uninjured knee
- Pregnant woman
- Neurological history with residual effects or taking medication that affects balance/coordination
- Inability to perform a muscular assessment
- Postoperative complications (deep vein thrombosis, sepsis, stiffness/arthrofibrosis)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Caen Normandie
Caen, 14000
Joffrey Drigny, MD MSC, +33231064533, drigny-j@chu-caen.fr
About this study
Official title: Association of Strength and Proprioception Parameters With Qualitative Assessment of Functional Tasks After ACL Reconstruction
The anterior cruciate ligament (ACL) injury is common in athletes aged 18 to 35. ACL reconstruction (ACLR) aims to restore knee stability in the process of returning to sports. Post-surgical rehabilitation focuses on optimizing biomechanical parameters, with neuromuscular and functional tests assessing muscle strength, proprioception, and dynamic stability. Isokinetic allows the measurement of muscle strength symmetry and proprioception, while the single-leg hop and landing tasks assess functional stability and are predictive of sports resumption and injury prevention. Despite progress, concerns remain about neuromuscular factors impacting knee stability, especially during landings, which can increase the risk of secondary ACL injuries.
This study proposes examining knee strength and proprioception using isokinetic dynamometry, alongside biomechanical assessments from functional tests, to explore their relationship to biomechanical features during landings, at 6-to-12 months post-ACL reconstruction. The hypothesis is that better muscle strength and proprioception correlate with improved knee control during landing tasks.
- Conditions
- ACL Injury
- Being tested
- Isokinetic neuromuscular assessment
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic neuromuscular assessmentDiagnostic test
All sports patients who had a muscle evaluation in addition to functional testing at 6-12 months after ACLR since March 2024
| Study group | Role | What they receive |
|---|---|---|
| ACL reconstruction group | All sports patients who had a muscle evaluation at 6 to 12 months after ACLR since March 2024 Receives: Diagnostic Test: Isokinetic neuromuscular assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive proprioceptive evaluation
Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Measured: One measurement during the visit at 6 to 12 months after surgery
Strength
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
Measured: One measurement during the visit at 6 to 12 months after surgery
Single Hop test
Measurement of knee position during landing from a single leg hop task
Measured: One measurement during the visit at 6 to 12 months after surgery
Single-leg landing task
Measurement of knee position during landing from a 30-cm box
Measured: One measurement during the visit at 6 to 12 months after surgery
Secondary outcomes (3)
Single Hop for Distance
The total distance is recorded (in cm)
Measured: One measurement during the visit at 6 to 12 months after surgery
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 the visit at 6 to 12 months after surgery
Landing Error Scoring System (LESS)
The LESS (Landing Error Scoring System) scale is a 13-item tool used to assess landing technique during a hop task.
Measured: One measurement during the visit at 6 to 12 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 posted29 Jul 2024
- Study start10 Mar 2024
- Primary completion24 Jul 2024
- Study completion30 Aug 2024 (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 InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
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
- NCT06524869
- Sponsor's protocol ID
- KASTLAB
- Acronym
- KASTLAB
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Faivre O, Prum G, Hulet C, Drigny J. Improved hamstring strength and knee position sense are associated with enhanced landing mechanics after anterior cruciate ligament reconstruction. J ISAKOS. 2025 Jun;12:100858. doi: 10.1016/j.jisako.2025.100858. Epub 2025 Apr 5.
PubMed 40194659
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Strength and Proprioception Parameters With Qualitative Assessment of Functional Tasks After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT06524869
- Acronym / sponsor ID
- KASTLAB / KASTLAB
- Conditions
- ACL Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 29 Jul 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.
The anterior cruciate ligament (ACL) injury is common in athletes aged 18 to 35. ACL reconstruction (ACLR) aims to restore knee stability in the process of returning to sports. Post-surgical rehabilitation focuses on optimizing biomechanical parameters, with neuromuscular and functional tests assessing muscle strength, proprioception, and dynamic stability. Isokinetic allows the measurement of muscle strength symmetry and proprioception, while the single-leg hop and landing tasks assess functional stability and are predictive of sports resumption and injury prevention. Despite progress, concerns remain about neuromuscular factors impacting knee stability, especially during landings, which can increase the risk of secondary ACL injuries.
This study proposes examining knee strength and proprioception using isokinetic dynamometry, alongside biomechanical assessments from functional tests, to explore their relationship to biomechanical features during landings, at 6-to-12 months post-ACL reconstruction. The hypothesis is that better muscle strength and proprioception correlate with improved knee control during landing tasks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL reconstruction group | – | Diagnostic Test: Isokinetic neuromuscular assessmentAll sports patients who had a muscle evaluation at 6 to 12 months after ACLR since March 2024 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All sports patients included in the sport medicine follow-up protocole with isokinetic muscular assessment at 6-12 months after ACL reconstruction surgery since March 2024 in the sports medicine department (Return To Sport Process)
Key inclusion criteria (3 listed)
- Adult patients, aged 18-40, who have undergone a first ACL reconstruction more than 6 months ago and are being followed in a sports medicine care pathway
- Affiliated with a health insurance plan
- Information form: Non-objection to the use of data for research purposes
Key exclusion criteria (8 listed)
- Previous ligament surgery of the lower limbs prior to ACL reconstruction
- Complex ligament injury (lateral ligaments, posterior cruciate ligament)
- Recent muscle injuries
- History of injury to the uninjured knee
- Pregnant woman
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 |
|---|---|---|
| Isokinetic neuromuscular assessmentAll sports patients who had a muscle evaluation in addition to functional testing at 6-12 months after ACLR since March 2024 | Diagnostic test | ACL reconstruction group |
Primary outcome
Passive proprioceptive evaluation
Time frame: One measurement during the visit at 6 to 12 months after surgery
Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Strength
Time frame: One measurement during the visit at 6 to 12 months after surgery
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
Single Hop test
Time frame: One measurement during the visit at 6 to 12 months after surgery
Measurement of knee position during landing from a single leg hop task
Single-leg landing task
Time frame: One measurement during the visit at 6 to 12 months after surgery
Measurement of knee position during landing from a 30-cm box
3 secondary outcomes
Single Hop for Distance
Time frame: One measurement during the visit at 6 to 12 months after surgery
ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)
Time frame: One measurement during the visit at 6 to 12 months after surgery
Landing Error Scoring System (LESS)
Time frame: One measurement during the visit at 6 to 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 40194659Faivre O, Prum G, Hulet C, Drigny J. Improved hamstring strength and knee position sense are associated with enhanced landing mechanics after anterior cruciate ligament reconstruction. J ISAKOS. 2025 Jun;12:100858. doi: 10.1016/j.jisako.2025.100858. Epub 2025 Apr 5.
- Individual participant dataSharing planned: Undecided
Related trials for ACL Injury
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingObservational study
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Injury, 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 8 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: status not confirmed, as of the sponsor's last update on 29 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive proprioceptive evaluation (time frame: One measurement during the visit at 6 to 12 months after surgery). The study lists 4 primary outcomes in all. 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 NCT06524869, 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 29 Jul 2024.