The Use of NMES as a Home-based Therapy Following Total Knee Arthroplasty

August 21, 2015 updated by: Gearoid O Laighin, National University of Ireland, Galway, Ireland
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stimulation
Custom-built research muscle stimulator. Muscle stimulator is set to provide a comfortable stimulation when applied to the soleus muscle using two 5x5cm electrodes.
Device: Custom-built research muscle stimulator
Muscle stimulator
Placebo Comparator: Placebo-control
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.
Device: Custom-built research muscle stimulator
Muscle stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower limb 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
Venous hemodynamics using Doppler ultrasound
Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint range of motion 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
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
Time Frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
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
Time Frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
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
Time Frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
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
Time Frame: One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation
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)
Time Frame: One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation
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
Time Frame: 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
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
Time Frame: 6 weeks post-operation
System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales
6 weeks post-operation
Walking speed 10 metre walk test
Time Frame: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
10 metre walk test
Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Ireland, Galway, Ireland

Collaborators

Irish Research Council
Galway Clinic

Investigators

  • Principal Investigator: Sandra O'Connell, B.Sc, NUI Galway, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (Estimate)

January 21, 2015

Study Record Updates

Last Update Posted (Estimate)

August 24, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HB_NMES_PC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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