Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Physical Therapy; Total Knee Arthroplasty; Functional Recovery
• Intervention / Treatment: Procedure: NMES; Other: Usual Care

Detailed Description

Total Knee Arthroplasty (TKA) reduces pain and disability caused by knee osteoarthritis, but the surgery results in substantial trauma to the knee. This acute trauma exacerbates underlying weakness-especially in the quadriceps. This leads to muscle atrophy and likely contributes to the long-term weakness and disability patients with TKA experience relative to their healthy peers. Attenuating quadriceps strength loss should be a primary target for improving rehabilitation outcomes after TKA.

Neuromuscular electrical stimulation (NMES) is recommended in TKA clinical practice guidelines to attenuate quadriceps strength loss. In controlled settings, NMES has established efficacy and attenuates quadriceps strength loss by 40% in the first month after surgery by overriding muscle activation deficits and reducing muscle atrophy. However, the effectiveness of NMES after TKA has not been adequately studied in real-world clinical settings, and preliminary data suggests that less than 4% of rehabilitation clinicians are using NMES as recommended by current TKA practice guidelines.

To address this gap, the investigators will conduct a cluster randomized trial in two healthcare systems (UCHealth and Intermountain Health) and their associated outpatient physical therapy clinics (n=30) to evaluate the effectiveness and implementation of NMES to address musculoskeletal deficits after TKA.

The investigators will compare outcomes between patients who receive contemporary rehabilitation supported by a comprehensive NMES implementation strategy (NMES) to patients who receive contemporary musculoskeletal rehabilitation alone (Usual Care; Aim 1). The investigators will gather information on NMES implementation to promote its uptake and translation to clinical practice (Aim 2).

• Study Type: Interventional
• Enrollment (Estimated): 3250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maggie Givan, MA; Phone Number: 719.251.7533; Email: maggie.givan@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • UCHealth
      • Contact: Maggie Givan, MA; Phone Number: 719-251-7533; Email: maggie.givan@cuanschutz.edu
      • Principal Investigator: Michael Bade, PT, PhD
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Denver, Anschutz
      • Contact: Maggie Givan, MA; Phone Number: 719-251-7533; Email: maggie.givan@cuanschutz.edu
      • Principal Investigator: Jennifer Stevens-Lapsley, PT, PhD
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Health
      • Contact: Matt Schneider, MBA; Phone Number: 801-507-8065; Email: Matthew.Schneider@imail.org
      • Principal Investigator: Kate Minick, DPT, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NMES; Neuromuscular 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.	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.
Active Comparator: Usual Care; The Usual Care clinics will continue clinical practice as normal. Usual Care sites will not have overlap of personnel or training with NMES Sites.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 Second Sit-to-Stand (30-STS)	The 30-STS is a measure of lower body strength and stamina that consists of moving from sitting to a full stand as many times as possible in 30 seconds. More completions indicate better physical function.	Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Quadriceps Strength	A commercially available hand dynamometer that uses a Bluetooth-enabled tensile load sensor will be used to assess quadriceps strength. Load sensors are reliable and valid for assessing isometric quadriceps strength. Higher scores indicate more 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)	The Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL) provides a score of patients' self-reported knee stiffness, pain, and function. Scores range from 0% to 100%, with higher scores indicating fewer symptoms affecting activities of daily living.	Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Knee Range of Motion (ROM)	ROM measures the amount of movement a joint can make in a specific direction and will be assessed using a goniometer. Higher degrees of movement indicate better range of motion.	Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Visit Utilization	Visit utilization will be defined as the number of outpatient physical therapy visits attended during the patient's postoperative rehabilitation episode-of-care.	Post-operative PT baseline up to 24 weeks
Patient Satisfaction	A self-report satisfaction survey will be administered. Patient Satisfaction consists of items rated on a 5-point Likert scale. Higher scores indicate better satisfaction.	Post-operative 6 weeks
NMES Satisfaction	NMES Satisfaction is a self-report survey and consists of items rated on a 5 point Likert scale. Higher scores indicate better satisfaction.	Post-operative 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NMES Intensity	The magnitude of NMES-induced muscle contraction elicited by patient.	Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
NMES Adherence	The proportion of prescribed NMES minutes completed by a patient will be measured by NMES unit.	Post-operative week 6
RE-AIM Reach	Proportion of patients treated with NMES out of all eligible patients	Throughout experimental phase (about 2.5 years)
RE-AIM Adoption	Proportion of clinicians using NMES with at least 80% of eligible patients out of all trained clinicians at intervention clinics.	Throughout experimental phase (about 2.5 years)
RE-AIM Implementation	Proportion of prescribed NMES time (15 mins, twice per day) completed by patient (measured by NMES unit) over the course of the study.	Throughout experimental phase (about 2.5 years)
RE-AIM Maintenance	Proportion of clinicians using NMES with at least 80% of eligible patients out of all trained clinicians at intervention clinics.	6 months following end of experimental phase

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Aging (NIA); Intermountain Health Care, Inc.; University of Colorado Health
• Investigators: Principal Investigator: Jennifer Stevens-Lapsley, PT, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Older Adults; Physical Therapy; Physical Function; Implementation Science; NMES (Neuromuscular Electrical Stimulation); TKA (Total Knee Arthroplasty); RE-AIM: Reach Effectiveness Adoption Implementation Maintenance
• Other Study ID Numbers: 24-0868; R01AG084683 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be made available 12 months after primary study publication
• IPD Sharing Access Criteria: Data will be made available upon reasonable written request to the study team. The PI, Dr. Jennifer Stevens-Lapsley will review requests.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No