Venous Thrombosis
Conditions
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.
Interventions
DEVICECustom-built research muscle stimulator
Muscle stimulator
Sponsors
Galway Clinic
Irish Research Council
National University of Ireland, Galway, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
Countries
Ireland
Contacts
Primary ContactGearoid ÓLaighin, Ph.D
Outcome results
None listed