RecruitingNot ApplicableNCT06953375

Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty


Sponsor

University of Colorado, Denver

Enrollment

3,250 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Patients experience dramatic quadriceps strength loss after total knee replacement, which contributes to persistent weakness and reduced long-term function after surgery. Neuromuscular electrical stimulation (NMES) reduces quadriceps weakness and improves patient function after knee replacement, but it is drastically underused in rehabilitation practice. This randomized trial will examine the effectiveness and feasibility of a comprehensive strategy for implementing neuromuscular electrical stimulation after knee replacement in two large healthcare organizations.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • • UCHealth or Intermountain Health outpatient physical therapy clinic
  • Underwent primary unilateral TKA
  • Attended outpatient rehabilitation at a participating clinic within 5 days after TKA
  • Attended at least 3 total outpatient physical therapy visits in total

Exclusion Criteria2

  • NMES Contraindications \[Patients with implanted cardiovascular cardiovertedefibrillator (ICD), active cancer, post-operative diagnosed deep vein thrombosis (DVT) in involved lower extremity\]
  • Previous lower extremity arthroplasty less than 12 weeks prior to scheduled TKA surgical date

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Interventions

PROCEDURENMES

The NMES intervention protocol in this study ensures patients receive NMES intervention that is adequately dosed (dose = treatment minutes x intensity), delivered using evidence-based parameters, and feasible. The investigators will deliver NMES using a portable two-channel stimulator that the investigators have found to produce stronger muscle contractions than other portable NMES units and has been used in previous clinical studies. It also has a built-in compliance meter to monitor patient treatment minutes (adherence) to NMES application. NMES sites will perform routine collection of outcomes as part of standard practice.

OTHERUsual Care

Usual Care clinics will continue with routine collection and documentation of physical performance outcomes as standard practice. A combination of chart reviews and on-site or remote observation will allow for characterization of usual care components for descriptive comparison. Usual Care clinics including the facility, rehabilitation clinicians, and patients will not have access to NMES materials developed for this study.


Locations(3)

UCHealth

Aurora, Colorado, United States

University of Colorado Denver, Anschutz

Aurora, Colorado, United States

Intermountain Health

Murray, Utah, United States

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NCT06953375


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