Electrical Stimulation of the Muscle Pumps of the Leg (Muscle Pump)

November 3, 2020 updated by: Imperial College London
The most efficient way of electrically stimulating the calf muscles has not been identified. The investigators aim to investigate this using a matrix of electrical parameters, and measuring the outcome with vascular ultrasound of the leg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Blood is aided on its journey to the heart by the action of the muscles of the legs. Muscle contraction squeezes the deep veins of the leg and pushes blood upwards, back towards the heart. In immobilised patients, or those with blood vessel problems, the pumping process can be helped by machines that either squeeze or shock the muscles of the calf (e.g. intermittent pneumatic compression, electrical stimulating devices). Many are licensed for medical use, and some are common place in hospitals and outpatient departments.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Current good health

Exclusion Criteria:

  • History of cardiovascular disease
  • Ankle Brachial Pressure Index <0.9
  • Venous reflux>0.5s
  • Pregnancy

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: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Stimulation of muscle in this order: vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius
Device: Electrical stimulation (Digitimer)
Stimulation with Digitimer (DS7A HV, Digitimer Ltd, UK) over motor point of muscle in protocol. 1Hz, pulse duration 1ms, maximum compliance voltage 200V. Current set to twice motor threshold
Experimental: 2
Stimulation of muscle in this order: rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials
Device: Electrical stimulation (Digitimer)
Stimulation with Digitimer (DS7A HV, Digitimer Ltd, UK) over motor point of muscle in protocol. 1Hz, pulse duration 1ms, maximum compliance voltage 200V. Current set to twice motor threshold
Experimental: 3
Stimulation of muscle in this order: vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris
Device: Electrical stimulation (Digitimer)
Stimulation with Digitimer (DS7A HV, Digitimer Ltd, UK) over motor point of muscle in protocol. 1Hz, pulse duration 1ms, maximum compliance voltage 200V. Current set to twice motor threshold
Experimental: 4
Stimulation of muscle in this order: tibialis anterior, peroneus longus, and the medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis
Device: Electrical stimulation (Digitimer)
Stimulation with Digitimer (DS7A HV, Digitimer Ltd, UK) over motor point of muscle in protocol. 1Hz, pulse duration 1ms, maximum compliance voltage 200V. Current set to twice motor threshold
Experimental: 5
Stimulation of muscle in this order: peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior
Device: Electrical stimulation (Digitimer)
Stimulation with Digitimer (DS7A HV, Digitimer Ltd, UK) over motor point of muscle in protocol. 1Hz, pulse duration 1ms, maximum compliance voltage 200V. Current set to twice motor threshold
Experimental: 6
Stimulation of muscle in this order: medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus
Device: Electrical stimulation (Digitimer)
Stimulation with Digitimer (DS7A HV, Digitimer Ltd, UK) over motor point of muscle in protocol. 1Hz, pulse duration 1ms, maximum compliance voltage 200V. Current set to twice motor threshold
Experimental: 7
Stimulation of muscle in this order: lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius,
Device: Electrical stimulation (Digitimer)
Stimulation with Digitimer (DS7A HV, Digitimer Ltd, UK) over motor point of muscle in protocol. 1Hz, pulse duration 1ms, maximum compliance voltage 200V. Current set to twice motor threshold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous Haemodynamic Measurements (Volume Flow Rate)
Time Frame: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)
Measurement by ultrasound, in right femoral vein. Flow rate (ml/min).
Baseline compared to that after 10-mins stimulation (2-mins to take measurements)
Venous Haemodynamic Measurements (Time Averaged Maximum Velocity)
Time Frame: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)
Measurement by ultrasound, in right femoral vein. Time averaged maximum velocity (cm/s).
Baseline compared to that after 10-mins stimulation (2-mins to take measurements)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Grading on Stimulation
Time Frame: During stimulation (10-mins each muscle)
Visual analogue scale (0-minimum pain, to 100-maximum pain)
During stimulation (10-mins each muscle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimate)

August 25, 2015

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15IC2528

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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