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

Recruiting

Conditions: Spinal Cord Injury, Pressure Ulcers

Registration Number: NL-OMON21504

Lead Sponsor: VU, Vrije Universiteit Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

To be eligible to participate in this study, an individual must meet all of the following criteria:
-Individuals (male/female) with either a complete (AIS A) or incomplete (AIS B, C and D) chronic SCI*
-Age 18 years and older
-Intact gluteal and hamstring muscles.**
-Individuals with a time since injury < 5 years and a minimal incidence of 1 PU or more, or Individuals with a time since injury = 5 years and a minimal incidence of 1 PU or more within the last 5 years.***
-Able to lie in a prone position for at least 10 minutes (safely for the neck, comfortable, not compromising breathing and taking possible contractures into account)
*In this study, a chronic SCI is defined as follow: ‘Every individual with an SCI who has been discharged from a rehabilitation center.’
** Potential participants who underwent flap surgery or some other form of plastic surgery can still be included if the stimulation can induce a good muscle contraction.
***Only individuals with a PU in (Category 2-4) in the sacral or ischial tuberosity’s region will be included, according to the European pressure Ulcer Advisory Panel.(22).

Exclusion Criteria

Exclusion criteria are:
-Current PUs 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 ES (cancer, pregnant, metal implants in stimulation area)
-Recent or current participation in an ES-induced exercise program or study (up to 6 months prior to this 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
The primary outcome is the incidence of PUs, assessed by a blinded person assessing the presence or absence of a PU on a photo made by the participant or his/her caregiver. The incidence of a PU will be evaluated every 2 weeks.

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes include: interface pressure distribution, local circulation of the profunda femoris artery, muscle thickness of the hamstrings and gluteal muscles and questionnaires about different dimensions of life; participation, quality of life, etc. The secondary outcomes will be measured at baseline and 3, 6, 9 and 12 months after randomization.