To investigate whether daily electrical stimulation of gluteal and hamstring muscles combined with usual care is more effective than only usual in individuals with chronic SCI who often have PU*s and/or are at high of recurring PU*s regarding: 1)…
ID
Source
Brief title
Daily electrical stimulation to prevent pressure ulcers
Condition
- Other condition
- Spinal cord and nerve root disorders
Synonym
Health condition
dwarslaesie, decubitus
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter is PU incidence during one year.
Secondary outcome
Secondary outcome parameters are PU risk factors (interface pressure
distribution, local circulation, muscle size), participation, and
health-related quality of life. Other outcome parameters are societal as well
as healthcare cost, process evaluation and the usability of the electrical
stimulation system.
Background summary
Pressure ulcers (PU*s) are among the most prevalent complication in individuals
with spinal cord injury (SCI), resulting from sitting for extended periods,
disuse atrophy, increased sitting pressure, and reduced circulation. PU*s can
limit mobility, independence and decrease quality of life, are an important
cause of re-hospitalization, can lead to osteomyelitis, sepsis and even death.
Compared with usual care, activation of paralyzed muscles using electrical
stimulation has been shown to markedly increase paralyzed muscle mass and
improve circulation of skin and muscle, and might therefore be a useful method
to reduce PU incidence.
Study objective
To investigate whether daily electrical stimulation of gluteal and hamstring
muscles combined with usual care is more effective than only usual in
individuals with chronic SCI who often have PU*s and/or are at high of
recurring PU*s regarding: 1) reducing PU incidence; 2) improving a) factors
related to PU risk: interface- pressure distribution, local circulation, and
muscle size; b) mobility, participation, and quality of life.
The 3rd objective is to evaluate the association between risk factors (sitting
pressure distribution, blood circulation, muscle size) and PU
development/incidence. The last three objectives are: 4) To determine the
cost-effectiveness of this method compared with usual care alone; 5) To
investigate facilitators and barriers for the implementation and sustainability
of daily electrical stimulation within usual care; 6) To evaluate the long-term
usability and user-friendliness of this electrical stimulation system.
Study design
A prospective multicenter RCT design will be used with an economic and process
evaluation alongside. Follow-up will be 12 months.
Intervention
In addition to usual care, the intervention group will receive surface
electrical stimulation of the gluteal and hamstring muscles during one year (>1
hr/day, >4 days/wk).
Study burden and risks
Participants are asked to visit a rehabilitation center five times in 12
months. One appointment will be for checking whether the participant is
eligible for the study. The other 4 appointments consist of measuring blood
flow, muscle mass and siting pressure distribution. This will take about 90-150
minutes in total. To measure the PU incidence the experimental group and the
control group will get a notification or email every 2 weeks. To ask whether
there is a new PU or not. In addition to this, a picture of the gluteal area is
taken and sent every month to evaluate the sacral or ischial tuberosity*s
region. Participants will be asked to fill in an online questionnaire at
baseline and every 3 months.
Possible benefits of participating in this study are a lower PU incidence,
improved muscle mass, improved blood flow and a better sitting pressure
distribution due to electrical stimulation. Next to that participants will get
a 2 weeks wound check-up for free which can create more awareness for wound
prevention.
V.d. Boechorststraat 7-9
Amsterdam 1081 BT
NL
V.d. Boechorststraat 7-9
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a participant must meet
all of the following criteria for the objective:
- Individuals (Male/Female) either a complete or incomplete chronic SCI*
- Age 18 and older
- Intact gluteal and hamstring muscles.**
- Individuals within a 5 year time since injury and a minimal incidence of 1 PU
or more***
- Individuals with a more than 5 year time since injury and a minimal incidence
of 1 PU or more within the last 5 years.***
- Can lay in a prone position for at least 10 minutes (safety neck,
comfortable, not compromising breathing and possibly due to contractures)
*In this study, a chronic SCI is defined as follow: *Every individual with an
SCI who is discharged from a rehabilitation center whether this is after 3, 6
or 12 months of first inpatient rehabilitation.*
** Potential participant who underwent flap surgery or another kind of plastic
surgery can still be included if they got a good muscle contraction.
***Only PU*s within the (Category 2-4) In the sacral or ischial tuberosity*s
region according to the European pressure Ulcer Advisory Panel.(28).
Exclusion criteria
- current PU*s in the gluteal or sacral area
- flaccid paralysis (areflexia)
- a history of severe autonomic dysreflexia
- Insufficient mastery of the Dutch language (speaking and reading)
- severe cognitive or communicative disorders
- intolerance to or contra indication for electrical stimulation (cancer,
pregnant)
- recent or current participation in an electrical stimulation-induced exercise
program
- participation will be excluded if they participated in an ES study or ES
therapy 6 months prior to the study
- severe psychiatric illness or disorders (to the discretion of the treating
rehabilitation physician).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74020.029.20 |
| Other | NL9469 |