NCT06953375 · University of Colorado, Denver
Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Timed Up and Go (TUG)
Time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
The TUG is a measure of mobility and balance that consists of rising from a seated position, walking three meters, and pivoting and returning to the original seated position. Faster times indicate better physical function.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Site Inclusion Criteria: • UCHealth or Intermountain Health outpatient physical therapy clinic Patient Inclusion Criteria:
- 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 criteria
- Patient Exclusion Criteria:
- 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
Where
- Aurora, Colorado
- Murray, Utah
Collaborators
University of Colorado Health, Intermountain Health Care, Inc., National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2025 · Source of record for eligibility and locations