NCT02343198

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

January 12, 2015

Last Update Submit

August 21, 2015

Conditions

Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Joint range of motion 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

    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

    Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation

  • Activity levels 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

    One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation

  • +4 more secondary outcomes

Study Arms (2)

Stimulation

EXPERIMENTAL

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

Placebo-control

PLACEBO COMPARATOR

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

Interventions

Custom-built research muscle stimulatorDEVICE

Muscle stimulator

Placebo-controlStimulation

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient undergoing knee arthroplasty in the Galway Clinic with an ability to understand the nature of the study
  • Ability to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Galway Clinic

Galway, Ireland

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Sandra O'Connell, B.Sc

    NUI Galway, Ireland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gearoid ÓLaighin, Ph.D

CONTACT

91492685gearoid.olaighin@nuigalway.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 21, 2015

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

IE(1)