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Interventions to Enhance Quadriceps Output After ACLR

Clinical Interventions to Acutely Enhance Quadriceps Output After Anterior Cruciate Ligament Reconstruction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07674784
Enrollment
22
Registered
2026-06-30
Start date
2026-09-01
Completion date
2027-08-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL

Keywords

ACLR, quadriceps, neuromuscular electrical stimulation, vibration

Brief 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. 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.

Interventions

DEVICENMES

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).

DEVICEVibration

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.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Have undergone ACLR within the previous 4 months * Are at least 2 months post-ACLR

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frame
Change in knee extensor peak torque productionmeasured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks

Secondary

MeasureTime frame
Change in knee extensor torque steadinessmeasured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks

Countries

United States

Contacts

CONTACTDaniel Cobian, DPT, PhD
cobian@ortho.wisc.edu608-262-0013
PRINCIPAL_INVESTIGATORDaniel Cobian, DPT, PhD

University of Wisconsin, Madison

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026