Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

NCT06953375 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3250

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

  • Total Knee Arthroplasty
  • Functional Recovery
  • Aging
  • Physical Therapy

Interventions

PROCEDURE

NMES

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.

OTHER

Usual 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.

Sponsors & Collaborators

  • University of Colorado Health

    collaborator OTHER
  • Intermountain Health Care, Inc.

    collaborator OTHER
  • National Institute on Aging (NIA)

    collaborator NIH
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jennifer Stevens-Lapsley, PT, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06953375 on ClinicalTrials.gov