The main purpose of this study is to evaluate the effects of surface electrical stimulation of the gluteal and hamstring muscles on sitting pressure under the buttocks during daily life (3 hours). A second purpose is to compare the effects of only…
ID
Source
Brief title
Condition
- Other condition
- Spinal cord and nerve root disorders
Synonym
Health condition
dwarslaesie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sitting pressure distribution and user friendliness of the electrical
stimulation method.
Secondary outcome
not applicable
Background summary
Pressures sores are mainly caused by pressure, shear forces, friction, or a
combination of these and usually occur over bony prominences such as the
ischial tuberosity. Wheelchair users with spinal cord injuries (SCI) sit for
long periods, resulting in long lasting high pressures of the tissue, which may
be even higher due to atrophy of the paralyzed muscles, leading to higher local
peak pressures. In addition, blood flow is reduced below the lesion due to a
loss of capillary network, failure of the skeletal muscle pump mechanism, drop
in blood pressure and occlusion of blood vessels.
Several methods have been developed to prevent pressure sores by improving the
sitting pressure distribution, e.g. special cushions and protective behavior
(e.g., lifting). Although the cushions can improve sitting pressure
distribution, they do not reduce muscle atrophy or improve blood flow.
Protective behavior has no unambiguous effect on the development of pressure
sores. Apparently, these methods may not be completely adequate, indicating a
need for additional methods.
A method to accomplish a better sitting pressure distribution, reduced muscle
atrophy, and increased blood flow is by activating the gluteal muscles using
electrical stimulation (ES), temporarily changing the buttock shape and
concomitantly the sitting pressure distribution. Until now, not much is known
about this method.
Study objective
The main purpose of this study is to evaluate the effects of surface electrical
stimulation of the gluteal and hamstring muscles on sitting pressure under the
buttocks during daily life (3 hours). A second purpose is to compare the
effects of only gluteal muscle activation with a combined gluteal-hamstring
muscle stimulation.
Study design
Intervention study, no control group.
Intervention
Activation of the paralyzed gluteal and hamstring muscles by electrical
stimulation.
Study burden and risks
The extra physical burden on the subjects is minimal. The paralyzed muscles
will contract but this will have hardly any effect on the subject. He/she will
be able to perform daily activities as usual. The time needed for this project
is limited to 14 hours for each subject, divided ovcer 2 sessions. There is a
small chance that the subjects find the stimulation painful. In that case, the
current will be decreased immediately. In about 10% of the population,
electrical stimulation may induce autonomic dysreflexia (high blood pressure).
This will be determined in a screening session. If this occurs, subjects will
be excluded from the experiments. The stimulation may induce some redness of
the skin, but this will disappear after a few hours.
Van der Boechorststraat 9
1081BT Amsterdam
Nederland
Van der Boechorststraat 9
1081BT Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- spinal cord injury
- age: 18-70 yrs.
- intact patella tendon reflex (upper motor neuron lesion)
- intact mm. gluteï maximi en hamstrings
Exclusion criteria
- presence of a pressure sore on buttocks
- flaccid paralysis (no muscle activation by surface electrical stimulation possible)
- occurrence of autonomic dysreflexia with electrical stimulation
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 | NL22712.029.08 |