dwarslaesie, decubitus Bedsores Pressure ulcers
Conditions
Interventions
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).
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome parameter is PU incidence during one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed