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Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

ConditionsTotal Knee ArthroplastyFunctional RecoveryAgingPhysical Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • NMES

    Procedure/Surgery

    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 intervention

    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.

Treatment groups

3,250 Participants
are divided into 2 treatment groups
Group A: NMESExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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.

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

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

Time frame
Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
3

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.

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

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.

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

Other outcomes

1

NMES Intensity

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

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

NMES Adherence

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

Time frame
Post-operative week 6
3

RE-AIM Reach

Proportion of patients treated with NMES out of all eligible patients

Time frame
Throughout experimental phase (about 2.5 years)
4

RE-AIM Adoption

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

Time frame
Throughout experimental phase (about 2.5 years)

Sponsors and contacts

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University of Colorado, Denver

Lead sponsor

University of Colorado Health

Collaborator

Intermountain Health Care, Inc.

Collaborator

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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