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

National University of Ireland, Galway, Ireland

Status: Unknown

Conditions: Venous Thrombosis

Treatments: Device: Custom-built research muscle stimulator

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02343198

HB_NMES_PC

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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
• Not excluded based on exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Stimulation

Experimental group

Description:

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

Treatment:

Device: Custom-built research muscle stimulator

Placebo-control

Placebo Comparator group

Description:

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.

Treatment:

Device: Custom-built research muscle stimulator