Regular electrical stimulation induced muscle activation increases muscle mass and volume and augments muscle, subcutaneous and skin blood flow in individuals with a spinal cord injury. Moreover, electrical stimulation applied to the ischial…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
-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.
Background summary
Pressure ulcers are the most prevalent secondary complication in individuals
with a spinal cord injury. 80% of people with a spinal cord injury suffer from
a pressure ulcer, and 91% of those are at risk of developing a recurrent
pressure ulcer. Pressure ulcers lead to radical consequences such as decreased
mobility and independence, delayed rehabilitation, rehospitalisation, and
exclusion from social activities. Furthermore, pressure ulcers have a
tremendous impact on the individual*s physical ability to participate in daily
life activities. Therefore, pressure ulcers place an enormous
physical/emotional/financial burden on the individual, their caregivers and
society. This highlights the need for interventions to prevent pressure ulcers.
Entrapment of soft tissue between bony prominences and an external surface
(such as a wheelchair) represents the primary cause of pressure ulcers.
Consequently, this leads to mechanical deformation, increased peak sitting
pressures and prolonged periods of relative hypoxia (reduced oxygen supply to
the tissue). The marked leg muscle loss in individuals with spinal cord injury
contributes importantly to the increase in mechanical deformation and increased
sitting pressures, whilst the impaired blood flow after a spinal cord injury
contributes to a local tissue oxygen deficiency. Consequently, these changes in
muscle size, sitting pressure and blood flow importantly contribute to the
increased risk for developing pressure ulcers in individuals with a spinal cord
injury.
Study objective
Regular electrical stimulation induced muscle activation increases muscle mass
and volume and augments muscle, subcutaneous and skin blood flow in individuals
with a spinal cord injury. Moreover, electrical stimulation applied to the
ischial tuberosity area (sitting bone) improves sitting pressure distribution.
Long term electrical stimulation of the gluteal muscles improves blood flow and
even increases gluteal muscle thickness. Although electrical stimulation is
potent in improving these key components in pressure ulcer development, current
electrical stimulation methods are limited by their laboratory based nature,
the need for trained personnel and expensive machinery; this importantly limits
the practicality of electrical stimulation. Therefore the proposed research
project is significant in that it involves the use of a home-based electrical
stimulation garment (shorts) with built in electrodes that overcomes these
limitations and can be used at home and in the community.
The aim of this study is to explore whether 3 months, daily use of electrical
stimulation in a home-based setting in individuals with SCI improves sitting
pressure distribution, muscle mass, skin circulation and dermatology quality of
life.
Study design
Twenty individuals with a spinal cord injury will receive an electrical
stimulation garment for 3 months.
Stimulation causes effective, comfortable levels of electrical stimulation with
visible muscle contractions, without significant limb movement
(checked/adjusted weekly if necessary). Participants will undergo daily
electrical stimulation..
Intervention
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 gluteal muscles above the
sitting area and 1 over halfway of the hamstring muscles, on both sides. The
surface electrodes (with conductive gel) are connected to elastic conductors,
guided through the side of the shorts to the front, ensuring the participant
does not sit on the wires. An eight-channel electrical stimulator connected to
the shorts will be used. Stimulation will be delivered biphasically at 50Hz to
induce a (visible) tetanic contraction. This amplitude will be applied with a
duty cycle of 1 s stimulation and 4 s rest for 3min with 16 min between each
block of stimulation. The average current amplitude using this stimulation
protocol has been 94±12.5mA, ranging from 70 to 115mA in our previous studies.
The current amplitude will be adjusted for each subject by increasing the
current amplitude in steps of 5mA to a point that doesn*t cause discomfort or
excessive muscle contractions that may disturb normal sitting. Weekly
telephone/skype questionnaires will also provide the opportunity to adjust the
intervention/stimulation.
The stimulation protocol will be delivered for 8 hours each day (during waking
hours). In the initial 2 weeks we will use an incremental 'dosage' protocol
whereby in the first week participants will undergo 4 hours of stimulation and
then 6 hours of stimulation in the 2nd week with 8 hours of stimulation
starting in week 3.
Study burden and risks
The paralyzed gluteal and hamstring muscles of the participants will be
activated. This will cause no pain and will not be uncomfortable. A small risk
of skin irritation under the electrodes exists, but this irritation will
disappear quickly after removal of the electrode.
Van der Boechorststraat 9
Amsterdam 1081BT
NL
Van der Boechorststraat 9
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
* Age 18-75 years
* ASIA Impairment Scale A-B with intact reflex arcs (i.e. spastic paralysis)
* Lesion level * Time since injury >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
* 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL58476.048.16 |