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NCT Number: NCT06953375

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth, Aurora, Colorado, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NMES

Procedure

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

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 30 Second Sit-to-Stand (30-STS)

    Time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks

    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.

  2. Quadriceps Strength

    Time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks

    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

  3. Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL)

    Time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks

    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.

  4. Knee Range of Motion (ROM)

    Time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks

    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.

  5. Visit Utilization

    Time frame: Post-operative PT baseline up to 24 weeks

    Visit utilization will be defined as the number of outpatient physical therapy visits attended during the patient's postoperative rehabilitation episode-of-care.

  6. Patient Satisfaction

    Time frame: Post-operative 6 weeks

    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.

  7. NMES Satisfaction

    Time frame: Post-operative 6 weeks

    NMES Satisfaction is a self-report survey and consists of items rated on a 5 point Likert scale. Higher scores indicate better satisfaction.

Other outcomes

  1. NMES Intensity

    Time frame: Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks

    The magnitude of NMES-induced muscle contraction elicited by patient.

  2. NMES Adherence

    Time frame: Post-operative week 6

    The proportion of prescribed NMES minutes completed by a patient will be measured by NMES unit.

  3. RE-AIM Reach

    Time frame: Throughout experimental phase (about 2.5 years)

    Proportion of patients treated with NMES out of all eligible patients

  4. RE-AIM Adoption

    Time frame: Throughout experimental phase (about 2.5 years)

    Proportion of clinicians using NMES with at least 80% of eligible patients out of all trained clinicians at intervention clinics.

  5. RE-AIM Implementation

    Time frame: Throughout experimental phase (about 2.5 years)

    Proportion of prescribed NMES time (15 mins, twice per day) completed by patient (measured by NMES unit) over the course of the study.

  6. RE-AIM Maintenance

    Time frame: 6 months following end of experimental phase

    Proportion of clinicians using NMES with at least 80% of eligible patients out of all trained clinicians at intervention clinics.

Study contacts

Contact information is provided by the study sponsor or research team.

Maggie Givan, MA

CONTACT

[email protected]

719.251.7533

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Intermountain Health Care, Inc.
  • National Institute on Aging (NIA)
  • University of Colorado Health

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 1, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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