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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Ireland, Galway, Ireland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Irish Research Council
Galway Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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