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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Stimulation of muscle in this order: vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius |
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| 2 | Experimental | Stimulation of muscle in this order: rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials |
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| 3 | Experimental | Stimulation of muscle in this order: vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris |
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| 4 | Experimental | Stimulation of muscle in this order: tibialis anterior, peroneus longus, and the medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis |
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| 5 | Experimental | Stimulation of muscle in this order: peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical stimulation (Digitimer) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Venous Haemodynamic Measurements (Volume Flow Rate) | 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) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Grading on Stimulation | Visual analogue scale (0-minimum pain, to 100-maximum pain) | During stimulation (10-mins each muscle) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alun Davies | Imperial College London | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26993869 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Electrical Muscle Stimulation Participants | All participants for electrical stimulation of respective muscles (tibialis anterior, peroneus longus, gastrocnemius, vastus lateralis, rectus femoris, vastus medialis) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Electrical Muscle Stimulation Participants | All participants for electrical stimulation of respective muscles (tibialis anterior, peroneus longus, gastrocnemius, vastus lateralis, rectus femoris, vastus medialis) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Venous Haemodynamic Measurements (Volume Flow Rate) | Measurement by ultrasound, in right femoral vein. Flow rate (ml/min). | Muscle stimulated | Posted | Median | Standard Deviation | ml/min | Baseline compared to that after 10-mins stimulation (2-mins to take measurements) |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electrical Muscle Stimulation Participants | All participants for electrical stimulation of respective muscles (tibialis anterior, peroneus longus, gastrocnemius, vastus lateralis, rectus femoris, vastus medialis) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miss Kate Williams | Imperial College London | k.williams@imperial.ac.uk |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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| 6 | Experimental | Stimulation of muscle in this order: medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus |
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| 7 | Experimental | Stimulation of muscle in this order: lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| OG004 | Gastrocnemius (Lateral) |
| OG005 | Tibialis Anterior |
| OG006 | Peroneus Longus |
|
|
|
| Primary | Venous Haemodynamic Measurements (Time Averaged Maximum Velocity) | Measurement by ultrasound, in right femoral vein. Time averaged maximum velocity (cm/s). | Muscle stimulated | Posted | Median | Standard Deviation | cm/s | Baseline compared to that after 10-mins stimulation (2-mins to take measurements) |
|
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|
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| Secondary | Pain Grading on Stimulation | Visual analogue scale (0-minimum pain, to 100-maximum pain) | Muscle stimulated | Posted | Mean | Standard Deviation | scores on a scale | During stimulation (10-mins each muscle) |
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|
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| Stimulation |
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