Venous ThrombosisNCT02343198
The Use of NMES as a Home-based Therapy Following Total Knee Arthroplasty
A study testing Custom-built research muscle stimulator in people with Venous Thrombosis, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Custom-built research muscle stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Galway Clinic
Galway
Sandra O'Connell, B.Sc, 860756430 ext. 353, s.oconnell10@nuigalway.ie
About this study
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).
Read the 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.
- Conditions
- Venous Thrombosis
- Being tested
- Custom-built research muscle stimulator
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-built research muscle stimulatorDevice
Muscle stimulator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Custom-built research muscle stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb venous hemodynamics using Doppler ultrasound
Venous hemodynamics using Doppler ultrasound
Measured: 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
Knee and ankle range of motion using a goniometer
Measured: 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
Circumference measures and volume calculations
Measured: 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
Visual analogue scale
Measured: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Activity levels ActivPAL activity monitor
ActivPAL activity monitor
Measured: 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
Lawton, Katz, Barthel scales
Measured: 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)
QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: 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
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
Measured: 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
System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales
Measured: 6 weeks post-operation
Walking speed 10 metre walk test
10 metre walk test
Measured: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Galway Clinic, Irish Research Council
- Responsible party
- Principal investigator, Gearoid O Laighin, National University of Ireland, Galway, Ireland
- Investigators
- Sandra O'Connell, B.Sc, Principal investigator, NUI Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343198
- Sponsor's protocol ID
- HB_NMES_PC
- Status last verified
- Aug 2015
- First submitted
- 12 Jan 2015
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of NMES as a Home-based Therapy Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02343198
- Acronym / sponsor ID
- HB_NMES_PC
- Conditions
- Venous Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Galway Clinic, Irish Research Council
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Device: Custom-built research muscle stimulatorCustom-built research muscle stimulator. Muscle stimulator is set to provide a comfortable stimulation when applied to the soleus muscle using two 5x5cm electrodes. |
| Placebo-control | Placebo comparator | Device: Custom-built research muscle stimulatorCustom-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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom-built research muscle stimulatorMuscle stimulator | Device | Placebo-control, Stimulation |
Primary outcome
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
9 secondary outcomes
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
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
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
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
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
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
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
Device usability System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra O'Connell, B.Sc principal investigator
NUI Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-built research muscle stimulator in people with Venous Thrombosis, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gearoid ÓLaighin, Ph.D (91492685 ext. +353, gearoid.olaighin@nuigalway.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.