Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06953375

Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

Led by University of Colorado, Denver · Updated on 2025-09-29

3250

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

U

University of Colorado Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

Patients undergoing total knee replacement often face significant loss of strength in the quadriceps muscle, leading to ongoing weakness and reduced function over time. This research focuses on studying neuromuscular electrical stimulation (NMES), a technique that may help reduce muscle weakness after surgery. The trial aims to evaluate how effective and feasible it is to implement NMES in real-world rehabilitation settings across two large healthcare organizations. The study compares two groups of patients recovering from total knee arthroplasty (TKA). One group receives standard rehabilitation care combined with NMES using a special portable device that helps stimulate muscle contractions and tracks treatment adherence. The other group receives usual rehabilitation care without NMES. This approach allows researchers to see if adding NMES improves recovery compared to typical care alone. Participants attend outpatient physical therapy clinics and are assessed before surgery and at several points after surgery, up to 24 weeks. The study measures physical function using tests like the Timed Up and Go, sit-to-stand, quadriceps strength, knee motion, and patient satisfaction. Researchers also monitor how well NMES is used and its impact on recovery. The total participation includes regular clinic visits and outcome assessments to track progress.

CONDITIONS

Brief Title

Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Outpatient physical therapy clinic is part of UCHealth or Intermountain Health
  • Patient underwent primary unilateral total knee arthroplasty
  • Patient attended outpatient rehabilitation at a participating clinic within 5 days after surgery
  • Patient attended at least 3 total outpatient physical therapy visits
Not Eligible

You will not qualify if you...

  • Patient has implanted cardiovascular cardioverter defibrillator (ICD), active cancer, or post-operative diagnosed deep vein thrombosis in the involved lower extremity
  • Patient had previous lower extremity arthroplasty less than 12 weeks before scheduled knee surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 24 weeks

Participants receive neuromuscular electrical stimulation (NMES) plus usual care rehabilitation or usual care rehabilitation alone after total knee arthroplasty to improve physical function during outpatient physical therapy.

Outpatient physical therapy visits beginning within 5 days after surgery and continuing for at least 3 visits, with assessments at baseline, 2 weeks, 4 weeks, 6 weeks, and up to 24 weeks

Trial Site Locations

Total: 3 locations

1

UCHealth

Aurora, Colorado, United States, 80045

Actively Recruiting

2

University of Colorado Denver, Anschutz

Aurora, Colorado, United States, 80045

Actively Recruiting

3

Intermountain Health

Murray, Utah, United States, 84107

Actively Recruiting

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Research Team

M

Maggie Givan, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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