Post Operative Use of Neuromuscular Electrical Stimulation (NMES) Device for ACLR Patients

March 13, 2026 updated by: Scott Mullen, University of Kansas Medical Center

Effects on Patient Outcomes With Post-Operative Use of Zynex Neuromuscular Electrical Stimulation (NMES): Zynex-25

This study is being conducted to learn about how neuromuscular electrical stimulation (NMES) in addition to standard of care aids in the recovery of muscle strength in patients undergoing ACLR procedure.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The addition of neuromuscular electrical stimulation (NMES) to standard ACLR rehabilitation has been demonstrated to improve knee extension and flexion compared to standard treatment only. NMES has also shown improved lower limb loading symmetry, walking velocity, stance time, cadence, maximum voluntary isometric contraction, motor unit behavior, muscle quality, and an increase in absolute muscle strength in functional tests compared to standard care of ACLR recovery. In this study we will be comparing bi-lateral presurgical and post surgical muscle strength symmetry in patients that follow the standard ACLR rehabilitation program and patients that use the NMES in addition to standard rehab.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ACLR surgical patients at KUMC sports medicine
  • 15 to 50 years old
  • BMI between 18 - 30 kg/m2
  • No limitations impacting physical function within the last 6 months (not including the ACL injury)

Exclusion Criteria:

  • Previous lower limb or spine injury involving surgical treatment
  • Prior spine surgery
  • Lower limb injury (other than ACL) preventing participation in physical activity for over two weeks in the past 6 months
  • Non english speaking
  • Vulnerable population, prisoner, or ward of the state

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NMES
All participants will use the NMES device in addition to standard rehab protocol
Device: Zynex NexWave Electrotherapy Device
All participants will use the NMES device in addition to standard rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilateral Muscle Symmetry Index
Time Frame: pre-operative to 3 months post-op
Comparing muscle size strength and function between operative and non-operative limbs
pre-operative to 3 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

August 22, 2025

First Submitted That Met QC Criteria

September 5, 2025

First Posted (Actual)

September 12, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00161884

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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