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Electrical Stimulation of the Muscle Pumps of the Leg

NCT ID: NCT02532556

Last Updated: 2020-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Haemodynamic Physiology

Keywords

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Haemodynamic physiology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Stimulation of muscle in this order: vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius

Group Type EXPERIMENTAL

Electrical stimulation (Digitimer)

Intervention Type DEVICE

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

2

Stimulation of muscle in this order: rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials

Group Type EXPERIMENTAL

Electrical stimulation (Digitimer)

Intervention Type DEVICE

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

3

Stimulation of muscle in this order: vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris

Group Type EXPERIMENTAL

Electrical stimulation (Digitimer)

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

Electrical stimulation (Digitimer)

Intervention Type DEVICE

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

5

Stimulation of muscle in this order: peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior

Group Type EXPERIMENTAL

Electrical stimulation (Digitimer)

Intervention Type DEVICE

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

6

Stimulation of muscle in this order: medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus

Group Type EXPERIMENTAL

Electrical stimulation (Digitimer)

Intervention Type DEVICE

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

7

Stimulation of muscle in this order: lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius,

Group Type EXPERIMENTAL

Electrical stimulation (Digitimer)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alun Davies

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

References

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Evans DR, Williams KJ, Strutton PH, Davies AH. The comparative hemodynamic efficacy of lower limb muscles using transcutaneous electrical stimulation. J Vasc Surg Venous Lymphat Disord. 2016 Apr;4(2):206-14. doi: 10.1016/j.jvsv.2015.10.009. Epub 2016 Jan 12.

Reference Type DERIVED
PMID: 26993869 (View on PubMed)

Other Identifiers

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15IC2528

Identifier Type: -

Identifier Source: org_study_id