To gain more insights in the mechanical properties of soft tissue under high risk for deep tissue injury type of pressure ulcers with US and MR Elastography.
ID
Source
Brief title
Condition
- Other condition
- Spinal cord and nerve root disorders
Synonym
Health condition
Decubitus
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mechanical properties of soft tissue susceptible for the onset to deep tissue
injury.
Secondary outcome
* Compare the mechanical properties of the gluteus muscles in healthy and SCI
individuals with US and MR Elastography
* Investigate the reproducibility of muscle mechanical properties measurements
with both US and MR Elastography in healthy volunteers
* Investigate the correlation of muscle mechanical properties measurements
found with US and MR Elastography in healthy volunteers
Background summary
A spinal cord injury (SCI) is accompanied with alterations in muscle properties
and it is expected that these pathological transformations go together with
changes in tissue mechanical properties. This induces elevated pressure and
shear stresses to soft tissue, and make them prone for developing deep tissue
injury. Mechanical properties of soft tissue will be examined as predictors for
deep tissue injury development.
Elastography is a method that is capable of quantifying tissue mechanical
properties and can either be performed with ultrasound (US) or Magnetic
Resonance (MR) modalities. Therefore, elastography (US and MR) will be used to
study muscle mechanical properties in gluteus muscles of healthy subjects
versus individuals with a spinal cord injury. An exploratory study will be
performed to investigate the feasibility of the elastography technique and to
ascertain the difference and variability in muscle mechanical properties of
healthy subjects and subjects with spinal cord injury.
Study objective
To gain more insights in the mechanical properties of soft tissue under high
risk for deep tissue injury type of pressure ulcers with US and MR
Elastography.
Study design
Prospective, exploratory cohort study
Study burden and risks
The study is completely non-invasive and no contrast agents will be
administered. The participant*s main burden is the time it takes to visit the
AMC and/or Spinoza Center. The participants in the study take part once. For
the individual participant, US and/or MRI could result in unexpected findings
of deep tissue injury that may require further work-up. Participants and their
general practitioner will be informed about this. The potential value of this
study is that more knowledge in the aetiology of deep tissue injury will be
obtained, resulting the development of a reliable diagnostic method based on
elastography for early detection of deep tissue injury. This will ultimately
benefit all patients who are in high risk for development of deep tissue injury
type of pressure ulcers.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* 18 years of age or older
* The capacity to understand the patient information sheet and the ability to provide written informed consent.;Healthy controls (group 2)
* will be matched in adapted BMI (adapted in scale to match Spinal Cord Injured in equivalent way), sex and age with spinal cord subjects in group 3 of this study.;Spinal Cord Injured group (group 3):
* Lesion of lower than vertebra C5. People with higher level lesions suffer from respiratory problems and need external ventilators. These ventilators are not MR compatible.
* Lesion acquired three months ago and longer. People with a more recent Spinal Cord Injury are in spinal shock period and still in rehabilitation.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Standard contraindications to MR imaging (e.g. cardiac pacemaker, cochlear implant, claustrophobia, pregnancy).
SCI group (group 3):
In case of known MR compatible implants and/or pump in body: extra check will be performed to verify specific implant with Reference Manual for Magnetic Resonance Safety, Implants, and Devices. If check is negative, subject is excluded.
* Waist / Shoulder width larger than 70 cm (diameter of MR scanner)
* Suffer from a current pressure ulcer.
* Medical history with respect to muscular diseases
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 | NL56835.018.16 |