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Electrical Stimulation of the Muscle Pumps of the Leg

Not Applicable
Completed
Conditions
Haemodynamic Physiology
Interventions
Device: Electrical stimulation (Digitimer)
Registration Number
NCT02532556
Lead Sponsor
Imperial College London
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
Inclusion Criteria
  • 18 years or older
  • Current good health
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Exclusion Criteria
  • History of cardiovascular disease
  • Ankle Brachial Pressure Index <0.9
  • Venous reflux>0.5s
  • Pregnancy
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Electrical stimulation (Digitimer)Stimulation of muscle in this order: vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius
6Electrical stimulation (Digitimer)Stimulation of muscle in this order: medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus
2Electrical stimulation (Digitimer)Stimulation of muscle in this order: rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials
4Electrical stimulation (Digitimer)Stimulation of muscle in this order: tibialis anterior, peroneus longus, and the medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis
7Electrical stimulation (Digitimer)Stimulation of muscle in this order: lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius,
3Electrical stimulation (Digitimer)Stimulation of muscle in this order: vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris
5Electrical stimulation (Digitimer)Stimulation of muscle in this order: peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior
Primary Outcome Measures
NameTimeMethod
Venous Haemodynamic Measurements (Volume Flow Rate)Baseline compared to that after 10-mins stimulation (2-mins to take measurements)

Measurement by ultrasound, in right femoral vein. Flow rate (ml/min).

Venous Haemodynamic Measurements (Time Averaged Maximum Velocity)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).

Secondary Outcome Measures
NameTimeMethod
Pain Grading on StimulationDuring stimulation (10-mins each muscle)

Visual analogue scale (0-minimum pain, to 100-maximum pain)

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