Clinical trial NCT02343198: The Use of NMES as a Home-based Therapy Following Total Knee Arthroplasty
Official title: The Use of NMES as a Home-based Therapy Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Thrombosis
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Galway Clinic
name: Irish Research Council
First posted: 2015-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lower limb venous hemodynamics using Doppler ultrasound
timeFrame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Secondary outcomes:
measure: Joint range of motion Knee and ankle range of motion using a goniometer
timeFrame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
measure: Lower limb swelling Circumference measures and volume calculations
timeFrame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
measure: Pain (associated with stimulation) on a visual analogue scale
timeFrame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
measure: Activity levels ActivPAL activity monitor
timeFrame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
measure: Activities of daily living Lawton, Katz, Barthel scales
timeFrame: One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation
measure: Quality of life QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation
measure: Compliance with use of the custom-built research muscle stimulator
timeFrame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
measure: Device usability System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales
timeFrame: 6 weeks post-operation
measure: Walking speed 10 metre walk test
timeFrame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway Clinic
Study officials:
affiliation: NUI Galway, Ireland
name: Sandra O'Connell, B.Sc
role: PRINCIPAL_INVESTIGATOR
References: