Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether early intervention with neuromuscular electrical stimulation (NMES) for muscle strengthening immediately after total knee arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

NCT06953375

Total Knee Arthroplasty Functional Recovery Aging +1 more

RECRUITING NA

Effects of Kneehab 12-week Peri-operative Total Knee Arthroplasty

NCT01096524

Knee Osteoarthritis Disuse Atrophy

COMPLETED PHASE3

Electrical Stimulation After Total Knee Arthroplasty

NCT00224913

Total Knee Arthroplasty Osteoarthritis

UNKNOWN PHASE1

Effects of Neuromuscular Electrical Stimulation (NMES) in Patients With Knee Osteoarthritis

NCT02061410

Knee Osteoarthritis

COMPLETED NA

An Intervention of Electrical Stimulation in Osteoarthritis

NCT00500448

Osteoarthritis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Osteoarthritis (OA) is a chronic degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. To alleviate pain and disability associated with knee OA, over 400,000 total knee arthroplasty (TKA) are performed each year in the United States, and future projections indicate that by the year 2030, more than 750,000 TKAs will be performed per year. While TKA reliably reduces pain and improves function, the recovery of force and function to normal levels is rare, which predisposes patients to future disability with increasing age. A month after TKA, impairments in quadriceps force are predominantly due to reflex inhibition, but are also influenced, to a lesser degree, by muscle atrophy. Neuromuscular electrical stimulation (NMES) may offer a promising alternative approach to override quadriceps reflex inhibition and prevent muscle atrophy to restore normal quadriceps muscle function more effectively than voluntary exercise alone, especially when applied within the first days after surgery.

The overall goal of this study is to evaluate the efficacy of NMES initiated 48hrs after TKA as an adjunct to standard rehabilitation. NMES is expected to more effectively restore normal quadriceps muscle function to produce greater quadriceps force by decreasing reflex inhibition. Patients will be randomized into one of two rehabilitation groups: 1) the standard rehabilitation group or 2) standard rehabilitation + NMES.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neuromuscular Electrical Stimulation (NMES)

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation (NMES)

Intervention Type DEVICE

NMES 20 minutes twice a day for 6 weeks plus standard physical therapy

Standard Rehabilitation Protocol

Group Type ACTIVE_COMPARATOR

Standard Rehabilitation Protocol

Intervention Type OTHER

Standard physical therapy for 8 weeks after surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neuromuscular Electrical Stimulation (NMES)

NMES 20 minutes twice a day for 6 weeks plus standard physical therapy

Intervention Type DEVICE

Standard Rehabilitation Protocol

Standard physical therapy for 8 weeks after surgery

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 50-85 years of age
* Scheduled for a primary unilateral TKA
* Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study

Exclusion Criteria

* History of uncontrolled hypertension or uncontrolled diabetes
* Body mass index greater than 35 kg/m\^2
* Neurological, vascular or cardiac problems that significantly limit function
* Moderate or severe osteoarthritis or other orthopedic conditions in the non-operated lower extremity that limit function

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No