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

Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02343198
• Other study ID #: HB_NMES_PC
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2015
• Last updated: August 21, 2015
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: National University of Ireland, Galway, Ireland
• Contact: Gearoid ÓLaighin, Ph.D
• Phone: 91492685
• Email: gearoid.olaighin[@]nuigalway.ie
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Venous Thrombosis

Intervention

Device:
• Custom-built research muscle stimulator
Muscle stimulator

Locations

Country	Name	City	State
Ireland	Galway Clinic	Galway

Sponsors (3)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	Galway Clinic, Irish Research Council

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Lower limb swelling Circumference measures and volume calculations	Circumference measures and volume calculations	Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No