ACL InjuryACLQuadActNCT07156734
Effect of Contralateral NMES on Quadriceps Activation After ACL Injury or Surgery
A study testing Neuromuscular Electrical Stimulation in people with ACL Injury, run by Schulthess Klinik.
Trial summary
A major complication after cruciate ligament injury and surgery is arthrogenic muscle inhibition of the quadriceps, which is characterised by a deficit in voluntary muscle activation in the affected leg. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Neuromuscular Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing ACL surgery with semitendinosus tendon autograft in the Schulthess Clinic
- Unilateral and primary ACL injury (with/without diagnoses of additional meniscus injury)
Who cannot join
- Previous surgery/ligament rupture in injured or uninjured knee or hip
- Severe pain in the uninjured-side quadriceps or knee joint
- Ongoing pregnancy
- BMI >30 kg/m²
- Neuromuscular disease
- Open wounds or tissue injuries on the anterior aspect of the thigh
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- Additional rupture of other knee ligaments (posterior cruciate ligament, medial collateral ligament, lateral collateral ligament)
- Implanted metallic/electronic devices (cardiac pacemakers, defibrillators)
- Patients getting a femoralis block (peripheral nerve block) after surgery will be excluded for the post-surgical appointment
- Insufficient language comprehension
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Does NMES Applied to the Contralateral Uninjured Side Facilitate Voluntary Quadriceps Activation Before and After ACL Surgery?
A major complication after cruciate ligament injury and surgery is arthrogenic muscle inhibition of the quadriceps, which is characterised by a deficit in voluntary muscle activation in the affected leg. This can hinder rehabilitation processes, lead to impaired knee function, and negatively impact the patients' quality of life. The primary objective of this study is to assess whether voluntary quadriceps activation on the injured side is facilitated by the concomitant application of neuromuscular electrical stimulation (NMES) on the contralateral quadriceps.
Read the detailed description
The primary objective of this study is to assess whether injured-side voluntary quadriceps activation before and after ACL surgery is facilitated by the concomitant application of NMES on the contralateral quadriceps (uninjured side), in comparison to a control (CTRL) condition that does not involve any contralateral activity (passive rest) and to a voluntary (VOL) condition that involves a maximal voluntary contraction of the contralateral quadriceps.
- Conditions
- ACL Injury
- Being tested
- Neuromuscular Electrical Stimulation
- 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.
Neuromuscular Electrical StimulationDevice
Studies in healthy individuals have demonstrated that NMES applied to the quadriceps of one limb induces short-term increases in strength and neural drive in the contralateral homologous muscle. Since these effects have only been observed in healthy individuals, it is essential to investigate whether similar responses occur in ACL patients.
| Study group | Role | What they receive |
|---|---|---|
| Contralateral NMES | Experimental | Participants receive neuromuscular electrical stimulation (NMES) applied to the quadriceps muscle of the contralateral leg while performing voluntary quadriceps contractions on the injured side. Each participant completes two sessions: one after ACL injury and one after ACL reconstruction surgery. Receives: Device: Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG activity
EMG data will be recorded from the vastus medialis, vastus lateralis and rectus femoris muscles.
Measured: Data will be collected at two time points: after ACL injury (within two weeks prior to surgery) and following ACL reconstruction (within three days post-surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Maffiuletti, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156734
- Sponsor's protocol ID
- 2025-00224
- Other IDs
- 2025
- Acronym
- ACLQuadAct
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 5 Sep 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does NMES Applied to the Contralateral Uninjured Side Facilitate Voluntary Quadriceps Activation Before and After ACL Surgery?
- ClinicalTrials.gov ID
- NCT07156734
- Acronym / sponsor ID
- ACLQuadAct / 2025-00224
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Sep 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.
A major complication after cruciate ligament injury and surgery is arthrogenic muscle inhibition of the quadriceps, which is characterised by a deficit in voluntary muscle activation in the affected leg. This can hinder rehabilitation processes, lead to impaired knee function, and negatively impact the patients' quality of life. The primary objective of this study is to assess whether voluntary quadriceps activation on the injured side is facilitated by the concomitant application of neuromuscular electrical stimulation (NMES) on the contralateral quadriceps.
Detailed description
The primary objective of this study is to assess whether injured-side voluntary quadriceps activation before and after ACL surgery is facilitated by the concomitant application of NMES on the contralateral quadriceps (uninjured side), in comparison to a control (CTRL) condition that does not involve any contralateral activity (passive rest) and to a voluntary (VOL) condition that involves a maximal voluntary contraction of the contralateral quadriceps.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contralateral NMES | Experimental | Device: Neuromuscular Electrical StimulationParticipants receive neuromuscular electrical stimulation (NMES) applied to the quadriceps muscle of the contralateral leg while performing voluntary quadriceps contractions on the injured side. Each participant completes two sessions: one after ACL injury and one after ACL reconstruction surgery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing ACL surgery with semitendinosus tendon autograft in the Schulthess Clinic
- Unilateral and primary ACL injury (with/without diagnoses of additional meniscus injury)
Key exclusion criteria (10 listed)
- Previous surgery/ligament rupture in injured or uninjured knee or hip
- Severe pain in the uninjured-side quadriceps or knee joint
- Ongoing pregnancy
- BMI >30 kg/m²
- Neuromuscular disease
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 |
|---|---|---|
| Neuromuscular Electrical StimulationStudies in healthy individuals have demonstrated that NMES applied to the quadriceps of one limb induces short-term increases in strength and neural drive in the contralateral homologous muscle. Since these effects have only been observed in healthy individuals, it is essential to investigate whether similar responses occur in ACL patients. | Device | Contralateral NMES |
Primary outcome
EMG activity
Time frame: Data will be collected at two time points: after ACL injury (within two weeks prior to surgery) and following ACL reconstruction (within three days post-surgery).
EMG data will be recorded from the vastus medialis, vastus lateralis and rectus femoris muscles.
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 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation in people with ACL Injury, run by Schulthess Klinik.
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 2 inclusion and 10 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 5 Sep 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 Nicola Angelo Maffiuletti, PhD (+41 44 385 75 79, nicola.maffiuletti@kws.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG activity (time frame: Data will be collected at two time points: after ACL injury (within two weeks prior to surgery) and following ACL reconstruction (within three days post-surgery).). 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 5 Sep 2025.