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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
50
Muscle stimulator
Galway Clinic
Galway, Ireland
RECRUITINGLower limb venous hemodynamics using Doppler ultrasound
Venous hemodynamics using Doppler ultrasound
Time frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Joint range of motion Knee and ankle range of motion using a goniometer
Knee and ankle range of motion using a goniometer
Time frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Lower limb swelling Circumference measures and volume calculations
Circumference measures and volume calculations
Time frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Pain (associated with stimulation) on a visual analogue scale
Visual analogue scale
Time frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Activity levels ActivPAL activity monitor
ActivPAL activity monitor
Time frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Activities of daily living Lawton, Katz, Barthel scales
Lawton, Katz, Barthel scales
Time frame: One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation
Quality of life QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS)
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QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation
Compliance with use of the custom-built research muscle stimulator
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
Time frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Device usability System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales
System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales
Time frame: 6 weeks post-operation
Walking speed 10 metre walk test
10 metre walk test
Time frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation