NCT07171346

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
25mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Feb 2026Jun 2028

First Submitted

Initial submission to the registry

August 22, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

August 22, 2025

Last Update Submit

March 13, 2026

Conditions

ElectrotherapyMuscle Atrophy or WeaknessACL ReconstructionACL SurgeryACL Injury

Keywords

Electrotherapymuscle strengthACLR

Outcome Measures

Primary Outcomes (1)

  • Bilateral Muscle Symmetry Index

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

    pre-operative to 3 months post-op

Study Arms (1)

NMES

EXPERIMENTAL

All participants will use the NMES device in addition to standard rehab protocol

Device: Zynex NexWave Electrotherapy Device

Interventions

Zynex NexWave Electrotherapy DeviceDEVICE

All participants will use the NMES device in addition to standard rehabilitation

NMES

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ACLR surgical patients at KUMC sports medicine
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (13)

  • Melkerson MN. Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave. In: Services DoHH, editor. Silver Spring, MD: Food and Drug Administration; 2011.

    BACKGROUND

  • Labanca L, Rocchi JE, Giannini S, Faloni ER, Montanari G, Mariani PP, Macaluso A. Early Superimposed NMES Training is Effective to Improve Strength and Function Following ACL Reconstruction with Hamstring Graft regardless of Tendon Regeneration. J Sports Sci Med. 2022 Feb 15;21(1):91-103. doi: 10.52082/jssm.2022.91. eCollection 2022 Mar.

    PMID: 35250338BACKGROUND

  • Snyder-Mackler L, Delitto A, Bailey SL, Stralka SW. Strength of the quadriceps femoris muscle and functional recovery after reconstruction of the anterior cruciate ligament. A prospective, randomized clinical trial of electrical stimulation. J Bone Joint Surg Am. 1995 Aug;77(8):1166-73. doi: 10.2106/00004623-199508000-00004.

    PMID: 7642660BACKGROUND

  • Conley CEW, Mattacola CG, Jochimsen KN, Dressler EV, Lattermann C, Howard JS. A Comparison of Neuromuscular Electrical Stimulation Parameters for Postoperative Quadriceps Strength in Patients After Knee Surgery: A Systematic Review. Sports Health. 2021 Mar;13(2):116-127. doi: 10.1177/1941738120964817. Epub 2021 Jan 11.

    PMID: 33428557BACKGROUND

  • Paternostro-Sluga T, Fialka C, Alacamliogliu Y, Saradeth T, Fialka-Moser V. Neuromuscular electrical stimulation after anterior cruciate ligament surgery. Clin Orthop Relat Res. 1999 Nov;(368):166-75.

    PMID: 10613165BACKGROUND

  • Jo HD, Kim MK. Effects of neuromuscular electrical stimulation on neuromuscular function and muscle quality in patient following anterior cruciate ligament reconstruction. J Exerc Rehabil. 2025 Apr 30;21(2):79-91. doi: 10.12965/jer.2550086.043. eCollection 2025 Apr.

    PMID: 40351372BACKGROUND

  • Snyder-Mackler L, Ladin Z, Schepsis AA, Young JC. Electrical stimulation of the thigh muscles after reconstruction of the anterior cruciate ligament. Effects of electrically elicited contraction of the quadriceps femoris and hamstring muscles on gait and on strength of the thigh muscles. J Bone Joint Surg Am. 1991 Aug;73(7):1025-36.

    PMID: 1874764BACKGROUND

  • Lepley LK, Wojtys EM, Palmieri-Smith RM. Combination of eccentric exercise and neuromuscular electrical stimulation to improve quadriceps function post-ACL reconstruction. Knee. 2015 Jun;22(3):270-7. doi: 10.1016/j.knee.2014.11.013. Epub 2014 Dec 10.

    PMID: 25819154BACKGROUND

  • Makihara Y, Nishino A, Fukubayashi T, Kanamori A. Decrease of knee flexion torque in patients with ACL reconstruction: combined analysis of the architecture and function of the knee flexor muscles. Knee Surg Sports Traumatol Arthrosc. 2006 Apr;14(4):310-7. doi: 10.1007/s00167-005-0701-2. Epub 2005 Oct 6.

    PMID: 16208458BACKGROUND

  • Konrath JM, Vertullo CJ, Kennedy BA, Bush HS, Barrett RS, Lloyd DG. Morphologic Characteristics and Strength of the Hamstring Muscles Remain Altered at 2 Years After Use of a Hamstring Tendon Graft in Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2016 Oct;44(10):2589-2598. doi: 10.1177/0363546516651441. Epub 2016 Jul 18.

    PMID: 27432052BACKGROUND

  • Nomura Y, Kuramochi R, Fukubayashi T. Evaluation of hamstring muscle strength and morphology after anterior cruciate ligament reconstruction. Scand J Med Sci Sports. 2015 Jun;25(3):301-7. doi: 10.1111/sms.12205. Epub 2014 Mar 20.

    PMID: 24646218BACKGROUND

  • Currier DP, Ray JM, Nyland J, Rooney JG, Noteboom JT, Kellogg R. Effects of electrical and electromagnetic stimulation after anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 1993 Apr;17(4):177-84. doi: 10.2519/jospt.1993.17.4.177.

    PMID: 8467342BACKGROUND

  • Heidland A, Fazeli G, Klassen A, Sebekova K, Hennemann H, Bahner U, Di Iorio B. Neuromuscular electrostimulation techniques: historical aspects and current possibilities in treatment of pain and muscle waisting. Clin Nephrol. 2013 Jan;79 Suppl 1:S12-23.

    PMID: 23249528BACKGROUND

Related Links

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesMuscular AtrophyAsthenia

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Orthopedic Surgery & Sports Medicine

Study Record Dates

First Submitted

August 22, 2025

First Posted

September 12, 2025

Study Start

February 10, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)