Novel, user-friendly, home-based electrostimulation-induced muscle activation in people with a spinal cord injury*

Novel, user-friendly, home-based electrostimulation-induced muscle activation in people with a spinal cord injury* - Electrical muscle stimulation and pressure ulcers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45626

Enrollment

Registered

2017-08-10

Start date

2017-07-01

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 garment (Axiobionics, Ann Arbor, MI, USA) will be custom-developed lycra shorts which house wires and surface electrodes. Two built-in surface electrodes are placed over the upper part of the

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 * No current pressure ulcers/damage to skin covering the ischial tuberosities and/or lower limbs * 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
The primary outcome measure will be the feasibility of using the shorts garment during the 3 months. More specifically: * Compliance (% of days worn, average time worn per day) * Recruitment rate (ratio of patients recruited and total number of patients invited) * Willingness of participants to be randomised into a randomised controlled trial * Time spent for instrumentation * Ability to wear the ES garment under normal clothing without discomfort/difficulties * Able to continue with day to day activities without impairment * Able to put the garment on themselves * Willingness to continue to use the garment	—

Measure

Time frame

The primary outcome measure will be the feasibility of using the shorts garment during the 3 months. More specifically: * Compliance (% of days worn, average time worn per day) * Recruitment rate (ratio of patients recruited and total number of patients invited) * Willingness of participants to be randomised into a randomised controlled trial * Time spent for instrumentation * Ability to wear the ES garment under normal clothing without discomfort/difficulties * Able to continue with day to day activities without impairment * Able to put the garment on themselves * Willingness to continue to use the garment

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Secondary

Measure	Time frame
-Muscle mass. Leg circumference measurement. -Perfusion on gluteal/thigh areas. Skin blood flow/vascular function (laser-Doppler flowmetry) Small areas (5 cm2) of the skin will be heated using small increments (1 deg C) every 5 min up to 44 deg C. The participant will lie sideways or on their front on a large purpose built bed during these tests. Muscle blood flow and Tissue oxygenation (reflection spectroscopy and laser-Doppler flowmetry) Small non-invasive probes will be placed on the gluteal/thigh skin areas. Oxygenation and perfusion data will be obtained using an Oxygen To See device (O2C, LEA Medizintechnik GmbH, Giessen, Germany). Assessments will be made in the participant*s wheelchair during various maneuvers (randomised order, 5-min seated rest before each condition): bending forward, leaning sideward (to the right side to release the probe), and push up (2-min maximum). -Pressure distribution. Ischial tuberosities interface pressure and pressure gradients will be assessed continuously (1Hz) using a force-sensitive mapping system (Force sensitive array, mFlex) placed between the wheelchair and buttocks. A thin 42 x 42cm soft flex mat containing 256 pressure sensors (1.82cm2 per sensor) will be used. -Clinical effects -Skin quality/pressure ulcer incidence. A clinician will score the quality of the skin, including possible incidence/severity of any pressure ulcers. -Quality of life. The self-completed Dermatology Life Quality Index will be used; a scoring list for individuals with (risk of) skin problems.	—

Measure

Time frame

-Muscle mass. Leg circumference measurement. -Perfusion on gluteal/thigh areas. Skin blood flow/vascular function (laser-Doppler flowmetry) Small areas (5 cm2) of the skin will be heated using small increments (1 deg C) every 5 min up to 44 deg C. The participant will lie sideways or on their front on a large purpose built bed during these tests. Muscle blood flow and Tissue oxygenation (reflection spectroscopy and laser-Doppler flowmetry) Small non-invasive probes will be placed on the gluteal/thigh skin areas. Oxygenation and perfusion data will be obtained using an Oxygen To See device (O2C, LEA Medizintechnik GmbH, Giessen, Germany). Assessments will be made in the participant*s wheelchair during various maneuvers (randomised order, 5-min seated rest before each condition): bending forward, leaning sideward (to the right side to release the probe), and push up (2-min maximum). -Pressure distribution. Ischial tuberosities interface pressure and pressure gradients will be assessed continuously (1Hz) using a force-sensitive mapping system (Force sensitive array, mFlex) placed between the wheelchair and buttocks. A thin 42 x 42cm soft flex mat containing 256 pressure sensors (1.82cm2 per sensor) will be used. -Clinical effects -Skin quality/pressure ulcer incidence. A clinician will score the quality of the skin, including possible incidence/severity of any pressure ulcers. -Quality of life. The self-completed Dermatology Life Quality Index will be used; a scoring list for individuals with (risk of) skin problems.

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Countries

Netherlands, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)