ACLNCT07674784
Interventions to Enhance Quadriceps Output After ACLR
A study testing NMES and Vibration in people with ACL, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The investigators are interested in determining what treatments are effective in reducing inhibition after anterior cruciate ligament (ACL) surgery and helping people increase quadriceps strength. Two interventions that are often used clinically are neuromuscular electrical stimulation (NMES) and vibration. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- ACL
- What is being tested?
- NMES and Vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Aug 2027
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have undergone ACLR within the previous 4 months
- Are at least 2 months post-ACLR
Who cannot join
- A history of ACLR on both legs
- Since the most recent ACLR:
- secondary lower extremity surgery
- leg or foot fracture
- Unable to walk without an assistive device
- Pain of greater than 5/10 during quadriceps strengthening exercises with the surgical limb
Show all 10Show fewer
- Cannot achieve 90 degrees of knee flexion with the surgical limb
- People with contraindications to NMES
- Anyone who had a previous skin reaction to NMES or attempted but could not tolerate NMES
- Peripheral neuropathy or other neurological conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW Health
Madison, Wisconsin, 53706
About this study
Official title: Clinical Interventions to Acutely Enhance Quadriceps Output After Anterior Cruciate Ligament Reconstruction
The investigators are interested in determining what treatments are effective in reducing inhibition after anterior cruciate ligament (ACL) surgery and helping people increase quadriceps strength. Two interventions that are often used clinically are neuromuscular electrical stimulation (NMES) and vibration. This is a study of how effective these treatments are, whether they work the same for everyone, and if one is better than the other. 22 participants will be enrolled and on study for 2 to 3 weeks.
Read the detailed description
After a screening visit, participants will be randomized to 2 intervention conditions over 2, 60-minute visits at least 1 week apart where they will complete:
- a 5 minute low intensity warm-up on a stationary bike
- a series of patient-reported outcomes surveys
- a pre-intervention quadriceps performance assessment
- the intervention condition, one each visit, either:
- ~20 minutes of NMES while completing rehabilitation exercises, OR
- ~20 minutes of hamstring muscle vibration
- a post-intervention quadriceps performance assessment
The primary objective of the study is to characterize the acute effects of interventions designed to mitigate the influence of inhibition (NMES and hamstrings muscle vibration) on quadriceps muscle performance in people post-anterior cruciate ligament reconstruction (ACLR) who have significant potential to benefit from these interventions (e.g. less than 4 months post-surgery).
- Specific Aim 1: To determine the acute effects of quadriceps NMES and hamstrings muscle vibration on quadriceps muscle performance in people 2-4 months post-ACLR
- Specific Aim 2: To determine if individuals with signs of more pronounced neural inhibition (quantified via assessment of knee extensor torque steadiness) have greater responses to NMES and hamstrings muscle vibration
Hypothesis 1: Quadriceps muscle strength will increase in people 2-4 months post-ACLR after 20 minutes of quadriceps NMES or hamstrings muscle vibration. The magnitude of increase in strength will be similar for both interventions.
Hypothesis 2: Surgical limb knee extensor torque steadiness will be strongly positively correlated with changes in quadriceps strength after NMES or hamstrings muscle vibration. People with greater steadiness impairments will demonstrate greater acute increases in quadriceps strength.
- Conditions
- ACL
- Being tested
- NMES, Vibration
- Keywords
- ACLR, quadriceps, neuromuscular electrical stimulation, vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
Also called Empi Continuum
The thigh of the surgical leg will be cleaned with isopropyl alcohol. 2.75" x 5" NMES electrodes (Dura-Stick Plus, Chattanooga, DJO Global, Dallas, TX) will be adhered to the proximal and distal aspects of the quadriceps muscles. An FDA-approved portable neuromuscular electrical stimulator (Empi Continuum, DJO Global, Dallas, TX) will be utilized to deliver a biphasic square wave pulse (frequency 75 Hz, pulse width 300 µs) to the quadriceps of the surgical limb. Participants will control both the amplitude of current delivered (0-100 mA) and the on/off timing of the stimulation via a wired control switch. Participants will complete common post-ACLR rehabilitation exercises while NMES is delivered (total time for exercises is approximately 20 minutes).
VibrationDevice
Also called Thumper Versa Pro
Participants will sit in a comfortable position on a treatment plinth with knees flexed to ~30°, hips flexed between 30-60°, and the back supported. The back of the thighs will rest on the vibration pads of a commercial vibration device (Thumper Versa Pro Massager, (Thumper Massager Inc., Markham, Ontario, CA). Participants will sit at rest for 20 minutes while the vibration device provides a 30 Hz vibration with an amplitude of ~6 mm.
| Study group | Role | What they receive |
|---|---|---|
| NMES then Vibration | Experimental | Not described Receives: Device: NMES; Device: Vibration |
| Vibration then NMES | Experimental | Not described Receives: Device: NMES; Device: Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee extensor peak torque production
Measured: measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
Secondary outcomes (1)
Change in knee extensor torque steadiness
Measured: measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACLStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Cobian, DPT, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674784
- Sponsor's protocol ID
- 2026-0153
- Other IDs
- Protocol Version 10/24/25, SMPH | Ortho and Rehab
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Interventions to Acutely Enhance Quadriceps Output After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07674784
- Acronym / sponsor ID
- 2026-0153
- Conditions
- ACL
- Keywords
- ACLR, quadriceps, neuromuscular electrical stimulation, vibration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Jun 2026 (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 investigators are interested in determining what treatments are effective in reducing inhibition after anterior cruciate ligament (ACL) surgery and helping people increase quadriceps strength. Two interventions that are often used clinically are neuromuscular electrical stimulation (NMES) and vibration. This is a study of how effective these treatments are, whether they work the same for everyone, and if one is better than the other. 22 participants will be enrolled and on study for 2 to 3 weeks.
Detailed description
After a screening visit, participants will be randomized to 2 intervention conditions over 2, 60-minute visits at least 1 week apart where they will complete:
- a 5 minute low intensity warm-up on a stationary bike
- a series of patient-reported outcomes surveys
- a pre-intervention quadriceps performance assessment
- the intervention condition, one each visit, either:
- ~20 minutes of NMES while completing rehabilitation exercises, OR
- ~20 minutes of hamstring muscle vibration
- a post-intervention quadriceps performance assessment
The primary objective of the study is to characterize the acute effects of interventions designed to mitigate the influence of inhibition (NMES and hamstrings muscle vibration) on quadriceps muscle performance in people post-anterior cruciate ligament reconstruction (ACLR) who have significant potential to benefit from these interventions (e.g. less than 4 months post-surgery).
- Specific Aim 1: To determine the acute effects of quadriceps NMES and hamstrings muscle vibration on quadriceps muscle performance in people 2-4 months post-ACLR
- Specific Aim 2: To determine if individuals with signs of more pronounced neural inhibition (quantified via assessment of knee extensor torque steadiness) have greater responses to NMES and hamstrings muscle vibration
Hypothesis 1: Quadriceps muscle strength will increase in people 2-4 months post-ACLR after 20 minutes of quadriceps NMES or hamstrings muscle vibration. The magnitude of increase in strength will be similar for both interventions.
Hypothesis 2: Surgical limb knee extensor torque steadiness will be strongly positively correlated with changes in quadriceps strength after NMES or hamstrings muscle vibration. People with greater steadiness impairments will demonstrate greater acute increases in quadriceps strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES then Vibration | Experimental | Device: NMES, Device: Vibration |
| Vibration then NMES | Experimental | Device: NMES, Device: Vibration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have undergone ACLR within the previous 4 months
- Are at least 2 months post-ACLR
Key exclusion criteria (10 listed)
- A history of ACLR on both legs
- Since the most recent ACLR:
- Unable to walk without an assistive device
- Pain of greater than 5/10 during quadriceps strengthening exercises with the surgical limb
- Cannot achieve 90 degrees of knee flexion with the surgical limb
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 |
|---|---|---|
| NMESAlso: Empi ContinuumThe thigh of the surgical leg will be cleaned with isopropyl alcohol. 2.75" x 5" NMES electrodes (Dura-Stick Plus, Chattanooga, DJO Global, Dallas, TX) will be adhered to the proximal and distal aspects of the quadriceps muscles. An FDA-approved portable neuromuscular electrical stimulator (Empi Continuum, DJO Global, Dallas, TX) will be utilized to deliver a biphasic square wave pulse (frequency 75 Hz, pulse width 300 µs) to the quadriceps of the surgical limb. Participants will control both the amplitude of current delivered (0-100 mA) and the on/off timing of the stimulation via a wired control switch. Participants will complete common post-ACLR rehabilitation exercises while NMES is delivered (total time for exercises is approximately 20 minutes). | Device | NMES then Vibration, Vibration then NMES |
| VibrationAlso: Thumper Versa ProParticipants will sit in a comfortable position on a treatment plinth with knees flexed to ~30°, hips flexed between 30-60°, and the back supported. The back of the thighs will rest on the vibration pads of a commercial vibration device (Thumper Versa Pro Massager, (Thumper Massager Inc., Markham, Ontario, CA). Participants will sit at rest for 20 minutes while the vibration device provides a 30 Hz vibration with an amplitude of ~6 mm. | Device | NMES then Vibration, Vibration then NMES |
Primary outcome
Change in knee extensor peak torque production
Time frame: measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
1 secondary outcome
Change in knee extensor torque steadiness
Time frame: measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
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 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for ACL
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
ACL, Opioid Use
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
Not yet recruiting
Three-dimensional Biomechanics of the Lower Limbs in Healthy Volunteers: Establishment of a Reference Database Using the MERItest® System
Healthy Adult Participants, Anterior Cruciate Ligament (ACL)
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.
Daniel Cobian, DPT, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES and Vibration in people with ACL, run by University of Wisconsin, Madison at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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 United States. 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?
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 Daniel Cobian, DPT, PhD (608-262-0013, cobian@ortho.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee extensor peak torque production (time frame: measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks). 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 1 Oct 2026.