Daily electrical stimulation to prevent recurring pressure ulcers in patients with a spinal cord injury compared to usual care

Recruiting

• Conditions: 10041543; dwarslaesie, decubitus; Bedsores; Pressure ulcers

• Registration Number: NL-OMON54487
• Lead Sponsor: Vrije Universiteit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameter is PU incidence during one year.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters are PU risk factors (interface pressure<br /><br>distribution, local circulation, muscle size), participation, and<br /><br>health-related quality of life. Other outcome parameters are societal as well<br /><br>as healthcare cost, process evaluation and the usability of the electrical<br /><br>stimulation system.</p><br>