NCT07674784

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 13, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 24, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

ACLRquadricepsneuromuscular electrical stimulationvibration

Outcome Measures

Primary Outcomes (1)

  • Change in knee extensor peak torque production

    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 pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks

Study Arms (2)

NMES then Vibration

EXPERIMENTAL
Device: NMESDevice: Vibration

Vibration then NMES

EXPERIMENTAL
Device: NMESDevice: Vibration

Interventions

NMESDEVICE

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).

Also known as: Empi Continuum
NMES then VibrationVibration then NMES
VibrationDEVICE

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.

Also known as: Thumper Versa Pro
NMES then VibrationVibration then NMES

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Health

Madison, Wisconsin, 53706, United States

Location

Study Officials

  • Daniel Cobian, DPT, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Cobian, DPT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2026

First Posted

June 30, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 13, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations