ACL - Anterior Cruciate Ligament RuptureQUADFAILNCT06783062
Activation Failure of Knee Extensors After Anterior Cruciate Ligament Rupture Depending on the Contraction Mode
An observational study of ACL - Anterior Cruciate Ligament Rupture and Activation Failure, run by La Tour Hospital.
Trial summary
The primary objective of the study is to evaluate the impact of ACL injury and ACL reconstruction on voluntary activation during maximal voluntary contraction (measured by neurophysiological parameters) according to the contraction mode. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture, Activation Failure, Contraction Mode
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Dec 2027
- How long will I take part?
- 9 Months
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will comprise both male and female subjects, divided into three groups. The first group will consist of 20 subjects with isolated (only ACL rupture) or non-isolated ACL rupture (rupture associated with other knee lesion), treated with rehabilitation. The second group will include 20 subjects with ACL rupture, treated with surgery and rehabilitation. A third control group will also be included.
Who may be able to join
- ACL-injured groups (surgically or conservatively treated):
- Age between 18 and 50 years
- Free, informed consent signed by the participant and the investigator.
- Session 1: Delay of 2 to 6 weeks after injury, with a quiet knee (range of motion 110- 0°, minimal effusion, maximal contraction pain ≤ 2/10)
- Session 2: Duration of 36 to 42 weeks after injury, with a quiet knee (range of motion 110-0°, minimal effusion, maximal contraction pain ≤ 2/10)
- Independent person (Unprotected: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision)
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- ControlGroup:
- Age between 18 and 50 years
- Free, informed consent signed by the participant and the investigator.
- Sport practitioners: at least once per week practicing activities like collective sports, racket sports, combat sports, skiing, or on-loading activities with changing of directions.
- Independent person (Unprotected: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision)
Who cannot join
- 1. Subjects fitted with an implanted electronic device such as a cardiac pacemaker 2. Professional athlete 3. Pregnant women 4. Subject with systemic pathology or treatment affecting the musculoskeletal system 5. Subject with a history of neurological pathology or traumatic pathology, or pathology that required orthopedic treatment and/or surgery of the knee, hip and/or lumbar spine 6. Contraindication to isokinetic testing: incapacitating pain, evolving pathological process, non- healed fracture, unbalanced cardiovascular pathology (angina pectoris, arterial hypertension) 7. Contralateral knee injury 8. Subject inability to follow procedures or insufficient knowledge of project language 9. Data acquisition issue or injury during testing
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
François Fourchet, PhD contact
About this study
The primary objective of the study is to evaluate the impact of ACL injury and ACL reconstruction on voluntary activation during maximal voluntary contraction (measured by neurophysiological parameters) according to the contraction mode.
The goal is to provide elements of knowledge to clinicians about the mechanisms of the activation failure depending on contraction mode, but also the resulting adapted clinical recommendations for conducting rehabilitation, and particularly for the use of different contraction modes.
Read more
The main hypothesis is that activation failure is not equal according to the contraction mode during maximal voluntary contractions and neurophysiological parameters will be decreased in comparison with non-injured subjects.
Secondary objectives are:
- To analyze the evolution of neurophysiological parameters between sessions interspaced by several months according to the contraction mode.
- To observe this time evolution depending on the treatment strategy chosen: rehabilitation or surgery plus rehabilitation.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described | |
| ACL - rehabilitation | Not described | |
| ACL - surgery + rehabilitation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary Activation Level
Measured: Between 2 and 6 weeks after ACL rupture
Secondary outcomes (5)
Maximal voluntary torque
Measured: between 2 to 6 weeks after ACL rupture
EMG activity of vastus lateralis, vastus medialis and rectus femoris
Quantified with root mean square (RMS), normalized to the maximal M-wave
Measured: between 2 to 6 weeks after ACL rupture
Voluntary Activation Level
Measured: Around 9 months after ACL rupture
Maximal voluntary torque
Measured: Around 9 months after ACL rupture
EMG activity of vastus lateralis, vastus medialis and rectus femoris
Measured: Around 9 months after ACL rupture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- La Tour Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Toulouse NeuroImaging Center (ToNIC - UMR 1214 Inserm/UPS)
- Responsible party
- Principal investigator, Simon Barrué-Belou, La Tour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783062
- Sponsor's protocol ID
- 2024-01580
- Acronym
- QUADFAIL
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation Failure of Knee Extensors After Anterior Cruciate Ligament Rupture Depending on the Contraction Mode
- ClinicalTrials.gov ID
- NCT06783062
- Acronym / sponsor ID
- QUADFAIL / 2024-01580
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- La Tour HospitalUniversity, hospital or other
- Collaborators
- Toulouse NeuroImaging Center (ToNIC - UMR 1214 Inserm/UPS)
- Study start
- Feb 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Jan 2025 (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 primary objective of the study is to evaluate the impact of ACL injury and ACL reconstruction on voluntary activation during maximal voluntary contraction (measured by neurophysiological parameters) according to the contraction mode.
The goal is to provide elements of knowledge to clinicians about the mechanisms of the activation failure depending on contraction mode, but also the resulting adapted clinical recommendations for conducting rehabilitation, and particularly for the use of different contraction modes.
The main hypothesis is that activation failure is not equal according to the contraction mode during maximal voluntary contractions and neurophysiological parameters will be decreased in comparison with non-injured subjects.
Secondary objectives are:
- To analyze the evolution of neurophysiological parameters between sessions interspaced by several months according to the contraction mode.
- To observe this time evolution depending on the treatment strategy chosen: rehabilitation or surgery plus rehabilitation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | – |
| ACL - rehabilitation | – | – |
| ACL - surgery + rehabilitation | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will comprise both male and female subjects, divided into three groups. The first group will consist of 20 subjects with isolated (only ACL rupture) or non-isolated ACL rupture (rupture associated with other knee lesion), treated with rehabilitation. The second group will include 20 subjects with ACL rupture, treated with surgery and rehabilitation. A third control group will also be included.
Key inclusion criteria (11 listed)
- ACL-injured groups (surgically or conservatively treated):
- Age between 18 and 50 years
- Free, informed consent signed by the participant and the investigator.
- Session 1: Delay of 2 to 6 weeks after injury, with a quiet knee (range of motion 110- 0°, minimal effusion, maximal contraction pain ≤ 2/10)
- Session 2: Duration of 36 to 42 weeks after injury, with a quiet knee (range of motion 110-0°, minimal effusion, maximal contraction pain ≤ 2/10)
Key exclusion criteria (1 listed)
- 1. Subjects fitted with an implanted electronic device such as a cardiac pacemaker 2. Professional athlete 3. Pregnant women 4. Subject with systemic pathology or treatment affecting the musculoskeletal system 5. Subject with a history of neurological pathology or traumatic pathology, or pathology that required orthopedic treatment and/or surgery of the knee, hip and/or lumbar spine 6. Contraindication to isokinetic testing: incapacitating pain, evolving pathological process, non- healed fracture, unbalanced cardiovascular pathology (angina pectoris, arterial hypertension) 7. Contralateral knee injury 8. Subject inability to follow procedures or insufficient knowledge of project language 9. Data acquisition issue or injury during testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Voluntary Activation Level
Time frame: Between 2 and 6 weeks after ACL rupture
5 secondary outcomes
Maximal voluntary torque
Time frame: between 2 to 6 weeks after ACL rupture
EMG activity of vastus lateralis, vastus medialis and rectus femoris
Time frame: between 2 to 6 weeks after ACL rupture
Voluntary Activation Level
Time frame: Around 9 months after ACL rupture
Maximal voluntary torque
Time frame: Around 9 months after ACL rupture
EMG activity of vastus lateralis, vastus medialis and rectus femoris
Time frame: Around 9 months after ACL rupture
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 20 Jan 2025.
- 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.
François Fourchet, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of ACL - Anterior Cruciate Ligament Rupture and Activation Failure, run by La Tour Hospital.
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 11 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: opening soon, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Simon Barrué-Belou, PhD (+41 22 719 78 92, simon.barruebelou@latour.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary Activation Level (time frame: Between 2 and 6 weeks after ACL rupture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.