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| Name | Class |
|---|---|
| Galway Clinic | NETWORK |
| Irish Research Council | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation | Experimental | Custom-built research muscle stimulator. Muscle stimulator is set to provide a comfortable stimulation when applied to the soleus muscle using two 5x5cm electrodes. |
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| Placebo-control | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom-built research muscle stimulator | Device | Muscle stimulator |
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| Measure | Description | Time Frame |
|---|---|---|
| Lower limb venous hemodynamics using Doppler ultrasound | Venous hemodynamics using Doppler ultrasound | Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Joint range of motion Knee and ankle range of motion using a goniometer | 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 |
| Lower limb swelling Circumference measures and volume calculations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gearoid ÓLaighin, Ph.D | Contact | 91492685 | +353 | gearoid.olaighin@nuigalway.ie |
| Name | Affiliation | Role |
|---|---|---|
| Sandra O'Connell, B.Sc | NUI Galway, Ireland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galway Clinic | Recruiting | Galway | Ireland |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Circumference measures and volume calculations |
| 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 | 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 | 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 | 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) | QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS) | 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 | 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 | 6 weeks post-operation |
| Walking speed 10 metre walk test | 10 metre walk test | Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation |