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Zynex NMES for Post-Operative ACL Rehabilitation

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What is being tested

Zynex NexWave Electrotherapy Device

Device
Who is being recruted

ACL Reconstruction
+2

+ ACL Surgery
+ ACL Injury
From 15 to 50 Years
+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorUniversity of Kansas Medical Center
Study ContactClinical Research Coordinator/Supervisor - Orthopedic Surgery
Last updated: September 12, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2025Actual date on which the first participant was enrolled.

This study explores the benefits of using Zynex Neuromuscular Electrical Stimulation (NMES) alongside regular rehabilitation for patients recovering from anterior cruciate ligament reconstruction (ACLR) surgery. The goal is to see if NMES can help improve knee movement, muscle strength, and walking abilities more effectively than standard rehabilitation alone. By understanding these effects, the study aims to offer better recovery options for people undergoing ACLR, potentially leading to quicker and more balanced recovery. Participants in the study will follow a typical ACLR rehabilitation program, but some will also use the NMES device. This device is applied to the muscles and sends electrical impulses to stimulate them, which may enhance muscle strength and movement. The study will compare muscle strength and movement symmetry before and after surgery in those using NMES and those who are not, to see if the NMES group shows better outcomes. This approach will help determine if adding NMES to standard rehab truly offers additional benefits.

Official TitleEffects on Patient Outcomes With Post-Operative Use of Zynex Neuromuscular Electrical Stimulation (NMES): Zynex-25 
Principal SponsorUniversity of Kansas Medical Center
Study ContactClinical Research Coordinator/Supervisor - Orthopedic Surgery
Last updated: September 12, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
25 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 15 to 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
ACL Reconstruction
ACL Surgery
ACL Injury
Electrotherapy
Muscle Atrophy or Weakness
Criteria
4 inclusion criteria required to participate
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)
5 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
All participants will use the NMES device in addition to standard rehab protocol
Study Objectives
Primary Objectives

Comparing muscle size strength and function between operative and non-operative limbs

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Kansas Medical CenterKansas City, United StatesSee the location
Recruiting soonOne Study Center