Recruiting

Neuromuscular Electrical Stimulation

Sponsor:

University of Colorado, Denver

Code:

NCT06953375

Conditions

Total Knee Arthroplasty

Functional Recovery

Aging

Physical Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NMES

Usual Care

Study Details

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.

Conditions

Total Knee Arthroplasty

Functional Recovery

Aging

Physical Therapy

Study ID

NCT06953375

Start date

May 12, 2025

Status verified date

Sep, 2025

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

3250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Maggie Givan, MA

719.251.7533maggie.givan@cuanschutz.edu

Locations

UCHealth

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Maggie Givan, MA

719-251-7533maggie.givan@cuanschutz.edu

Principal Investigator:

Michael Bade, PT, PhD

University of Colorado Denver, Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Maggie Givan, MA

719-251-7533maggie.givan@cuanschutz.edu

Principal Investigator:

Jennifer Stevens-Lapsley, PT, PhD

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

Contacts

Matt Schneider, MBA

801-507-8065Matthew.Schneider@imail.org

Principal Investigator:

Kate Minick, DPT, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Keywords

  • NMES (Neuromuscular Electrical Stimulation)
  • TKA (Total Knee Arthroplasty)
  • Rehabilitation
  • Physical Therapy
  • RE-AIM: Reach Effectiveness Adoption Implementation Maintenance
  • Implementation Science
  • Older Adults
  • Physical Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-09-29.