The Use of NMES as a Home-based Therapy Following Total Knee Arthroplasty
- Conditions
- Venous Thrombosis
- Interventions
- Device: Custom-built research muscle stimulator
- Registration Number
- NCT02343198
- Lead Sponsor
- National University of Ireland, Galway, Ireland
- Brief Summary
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).
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stimulation Custom-built research muscle stimulator Custom-built research muscle stimulator. Muscle stimulator is set to provide a comfortable stimulation when applied to the soleus muscle using two 5x5cm electrodes. Placebo-control Custom-built research muscle stimulator 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.
- Primary Outcome Measures
Name Time Method Lower limb venous hemodynamics using Doppler ultrasound Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation Venous hemodynamics using Doppler ultrasound
- Secondary Outcome Measures
Name Time Method Joint range of motion Knee and ankle range of motion using a goniometer Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation Knee and ankle range of motion using a goniometer
Lower limb swelling Circumference measures and volume calculations Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation Circumference measures and volume calculations
Pain (associated with stimulation) on a visual analogue scale Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation Visual analogue scale
Activity levels ActivPAL activity monitor Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation ActivPAL activity monitor
Activities of daily living Lawton, Katz, Barthel scales One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation Lawton, Katz, Barthel scales
Quality of life QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS) One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS)
Compliance with use of the custom-built research muscle stimulator Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation Compliance with the use of the research stimulator, i.e. adherence to the stimulation protocol for both the number of sessions and the duration of stimulation for each session over the 5 weeks the stimulator is used for
Device usability System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales 6 weeks post-operation System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales
Walking speed 10 metre walk test Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation 10 metre walk test
Trial Locations
- Locations (1)
Galway Clinic
🇮🇪Galway, Ireland