The Use of NMES as a Home-based Therapy Following Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-12-31

Brief Summary

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The use of neuromuscular electrical stimulation (NMES) as a home-based therapy following total knee arthroplasty. Measures of interest: lower limb venous hemodynamics, joint range of motion, lower limb swelling, walking speed, quality of life, activities of daily living, device usability, device compliance, activity levels, and pain (VAS).

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Detailed Description

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The use of neuromuscular electrical stimulation (NMES) as a home-based therapy following total knee arthroplasty. All participants receive and use a research stimulator for approximately 5 weeks following total knee arthroplasty. Participants randomised to either a stimulation group or placebo-controlled group. Stimulation of the soleus muscle to investigate the effects on lower limb venous hemodynamics, joint range of motion, lower limb swelling, walking speed, quality of life, activities of daily living, device usability, device compliance, activity levels, and pain (VAS) in both groups.

Conditions

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Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Stimulation

Custom-built research muscle stimulator. Muscle stimulator is set to provide a comfortable stimulation when applied to the soleus muscle using two 5x5cm electrodes.

Group Type EXPERIMENTAL

Custom-built research muscle stimulator

Intervention Type DEVICE

Muscle stimulator

Placebo-control

Custom-built research muscle stimulator. Muscle stimulator is set to provide sensory stimulation but will not cause an active muscle contraction. Stimulation is also delivered to the soleus muscle through two 5x5cm electrodes.

Group Type PLACEBO_COMPARATOR

Custom-built research muscle stimulator

Intervention Type DEVICE

Muscle stimulator

Interventions

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Custom-built research muscle stimulator

Muscle stimulator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Any patient undergoing knee arthroplasty in the Galway Clinic with an ability to understand the nature of the study
* Ability to give informed consent

Exclusion Criteria

* history of symptomatic heart disease or severe arterial disease
* pregnancy
* presence of a pacemaker
* history of neurological disorder
* presence of cognitive difficulties which may prevent the patient or his/her carer from using the stimulator properly

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes