Acute effects of unilateral lower limb electrical stimulation induced muscle activation on peripheral vascular blood flow in SCI

Acute effects of unilateral lower limb electrical stimulation induced muscle activation on peripheral vascular blood flow in SCI - Electrical stimulation and blood flow

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43259

Enrollment

Registered

2016-10-28

Start date

2016-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paraplegia spinal cord injury

Interventions

The ES intervention consists of a portable functional electrical stimulation box (Neuropro, BerkelBikes, Sint-Michielsgestel, The Netherlands) connected to a wearable garment (shorts), which will sa

circulation

electrical stimulation

pressure sores

spinal cord injury

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Age 18-75 years * ASIA Impairment Scale A-B with intact reflex arcs (i.e. spastic paralysis) * Lesion level 6 months * Able to tolerate stimulation (i.e. no autonomic dysreflexia induced)

Exclusion criteria

Exclusion criteria: * An intolerance to or contraindication for electrical stimulation * A history of severe autonomic dysreflexia or severe cognitive or communicative disorders * A flaccid paralysis or areflexia

Design outcomes

Primary

Measure	Time frame
Profunda femoral artery blood flow: The profunda is a deep artery of the thigh that travels more posteriorly than the rest of the femoral artery to supply the gluteal and hamstring muscles. Using a 2-dimensional echo Doppler ultrasound device, scans of the prounda femoral artery will be collected to determine artery diameter and blood flow (BF). Measurements will be performed at baseline (rest), every 15 minutes during the 2-hour stimulation protocol 30 minutes and 1-hour post stimulation in the intervention leg. Measurements in the unstimulated control leg will be performed pre and post stimulation. All measurements will be recorded for later offline analysis using custom-designed edge detection and wall tracking software Skin vascular function (CVC): Cutaneous blood flow will be measured on the gluteal/thigh area using laser-Doppler flowmetry (Periflux 5001, Sweden). Measurements will be performed pre, during and post stimulation in the control and intervention legs. Local skin temperature will be controlled at 33 °C using local heating units (Perimed 455, Sweden). Cutaneous vascular conductance (CVC) will be calculated as flux (AU) divided by MAP (mmHg).	—

Measure

Time frame

Profunda femoral artery blood flow: The profunda is a deep artery of the thigh that travels more posteriorly than the rest of the femoral artery to supply the gluteal and hamstring muscles. Using a 2-dimensional echo Doppler ultrasound device, scans of the prounda femoral artery will be collected to determine artery diameter and blood flow (BF). Measurements will be performed at baseline (rest), every 15 minutes during the 2-hour stimulation protocol 30 minutes and 1-hour post stimulation in the intervention leg. Measurements in the unstimulated control leg will be performed pre and post stimulation. All measurements will be recorded for later offline analysis using custom-designed edge detection and wall tracking software Skin vascular function (CVC): Cutaneous blood flow will be measured on the gluteal/thigh area using laser-Doppler flowmetry (Periflux 5001, Sweden). Measurements will be performed pre, during and post stimulation in the control and intervention legs. Local skin temperature will be controlled at 33 °C using local heating units (Perimed 455, Sweden). Cutaneous vascular conductance (CVC) will be calculated as flux (AU) divided by MAP (mmHg).

—

Secondary

Measure	Time frame
Energy Expenditure: Participants will wear a facemask and energy expenditure will be calculated based on oxygen consumption measured by open-circuit spirometry (COSMED K4b2, Rome, Italy). Mean energy expenditure without ES will be calculated during the first 10 minutes of the resting period before the start of ES. Mean energy expenditure during ES will be calculated over each block of ES during the 2-hour protocol.	—

Measure

Time frame

Energy Expenditure: Participants will wear a facemask and energy expenditure will be calculated based on oxygen consumption measured by open-circuit spirometry (COSMED K4b2, Rome, Italy). Mean energy expenditure without ES will be calculated during the first 10 minutes of the resting period before the start of ES. Mean energy expenditure during ES will be calculated over each block of ES during the 2-hour protocol.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)