Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty
2 other identifiers
interventional
3,250
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2025
CompletedStudy Start
First participant enrolled
May 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
September 29, 2025
September 1, 2025
3.9 years
November 21, 2024
September 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Timed Up and Go (TUG)
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.
Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Secondary Outcomes (7)
30 Second Sit-to-Stand (30-STS)
Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Quadriceps Strength
Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL)
Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Knee Range of Motion (ROM)
Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Visit Utilization
Post-operative PT baseline up to 24 weeks
- +2 more secondary outcomes
Other Outcomes (6)
NMES Intensity
Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
NMES Adherence
Post-operative week 6
RE-AIM Reach
Throughout experimental phase (about 2.5 years)
- +3 more other outcomes
Study Arms (2)
NMES
EXPERIMENTALNeuromuscular Electrical Stimulation (NMES) consists of usual care rehabilitation plus evidence-based implementation of NMES in the early postoperative period to improve physical function after TKA.
Usual Care
ACTIVE COMPARATORThe Usual Care clinics will continue clinical practice as normal. Usual Care sites will not have overlap of personnel or training with NMES Sites.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- University of Colorado Healthcollaborator
- Intermountain Health Care, Inc.collaborator
- National Institute on Aging (NIA)collaborator
Study Sites (3)
UCHealth
Aurora, Colorado, 80045, United States
University of Colorado Denver, Anschutz
Aurora, Colorado, 80045, United States
Intermountain Health
Murray, Utah, 84107, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Stevens-Lapsley, PT, PhD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Investigators will not be blinded to the arms due to facility/clinician training required for this study design. Study sites (i.e., outpatient physical therapy clinics) will be the unit of randomization. Study sites will be made broadly aware of the study initiative during the site recruitment process; however, the site will not be provided with detailed information about the intervention unless randomized to the Intervention arm. As such, clinicians, or rehabilitation care providers, at usual care sites will remain blinded to the intervention for the duration of the study. Clinicians will collect patient-level functional outcomes as part of their standard of care and all patients who are subjects of the intervention will not be aware of the group allocation in the study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2024
First Posted
May 1, 2025
Study Start
May 12, 2025
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- The data will be made available 12 months after primary study publication
- Access Criteria
- Data will be made available upon reasonable written request to the study team. The PI, Dr. Jennifer Stevens-Lapsley will review requests.
The study team guarantees that all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. Data will be made available in a timely manner to the broader scientific community, and will be complete, and as accurate as possible. All data released will be de-identified, with no information that could be linked to any study subjects, or participating study practices to ensure the confidentiality of all subjects and practices. If necessary, a data use agreement will be established.