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

Primary Purpose

Venous Thrombosis

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Custom-built research muscle stimulator
Sponsored by
National University of Ireland, Galway, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thrombosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Galway ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Stimulation

Placebo-control

Arm Description

Custom-built research muscle stimulator. Muscle stimulator is set to provide a comfortable stimulation when applied to the soleus muscle using two 5x5cm electrodes.

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.

Outcomes

Primary Outcome Measures

Lower limb venous hemodynamics using Doppler ultrasound
Venous hemodynamics using Doppler ultrasound

Secondary Outcome Measures

Joint range of motion Knee and ankle range of motion using a goniometer
Knee and ankle range of motion using a goniometer
Lower limb swelling Circumference measures and volume calculations
Circumference measures and volume calculations
Pain (associated with stimulation) on a visual analogue scale
Visual analogue scale
Activity levels ActivPAL activity monitor
ActivPAL activity monitor
Activities of daily living Lawton, Katz, Barthel scales
Lawton, Katz, Barthel scales
Quality of life QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS)
QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS)
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
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
Walking speed 10 metre walk test
10 metre walk test

Full Information

First Posted
January 12, 2015
Last Updated
August 21, 2015
Sponsor
National University of Ireland, Galway, Ireland
Collaborators
Galway Clinic, Irish Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT02343198
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Galway, Ireland
Collaborators
Galway Clinic, Irish Research Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulation
Arm Type
Experimental
Arm Description
Custom-built research muscle stimulator. Muscle stimulator is set to provide a comfortable stimulation when applied to the soleus muscle using two 5x5cm electrodes.
Arm Title
Placebo-control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Custom-built research muscle stimulator
Intervention Description
Muscle stimulator
Primary Outcome Measure Information:
Title
Lower limb venous hemodynamics using Doppler ultrasound
Description
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
Secondary Outcome Measure Information:
Title
Joint range of motion Knee and ankle range of motion using a goniometer
Description
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
Title
Lower limb swelling Circumference measures and volume calculations
Description
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
Title
Pain (associated with stimulation) on a visual analogue scale
Description
Visual analogue scale
Time Frame
Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Title
Activity levels ActivPAL activity monitor
Description
ActivPAL activity monitor
Time Frame
Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Title
Activities of daily living Lawton, Katz, Barthel scales
Description
Lawton, Katz, Barthel scales
Time Frame
One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation
Title
Quality of life QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
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
Title
Compliance with use of the custom-built research muscle stimulator
Description
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
Time Frame
Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Title
Device usability System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales
Description
System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales
Time Frame
6 weeks post-operation
Title
Walking speed 10 metre walk test
Description
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. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gearoid ÓLaighin, Ph.D
Phone
91492685
Ext
+353
Email
gearoid.olaighin@nuigalway.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra O'Connell, B.Sc
Organizational Affiliation
NUI Galway, Ireland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galway Clinic
City
Galway
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra O'Connell, B.Sc
Phone
860756430
Ext
353
Email
s.oconnell10@nuigalway.ie

12. IPD Sharing Statement

Learn more about this trial

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

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