Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06953375
Status
Recruiting
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Conditions

  • Aging
  • Functional Recovery
  • Physical Therapy
  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 12, 2025
Status verified
Sep 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
3,250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (3)

FacilityCityStateZIPSite coordinators
UCHealthAuroraColorado80045
Maggie Givan, MA
[email protected]
719-251-7533
Michael Bade, PT, PhD (PRINCIPAL_INVESTIGATOR)
University of Colorado Denver, AnschutzAuroraColorado80045
Maggie Givan, MA
[email protected]
719-251-7533
Jennifer Stevens-Lapsley, PT, PhD (PRINCIPAL_INVESTIGATOR)
Intermountain HealthMurrayUtah84107
Matt Schneider, MBA
[email protected]
801-507-8065
Kate Minick, DPT, PhD (PRINCIPAL_INVESTIGATOR)

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