R2 Research and Development

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Overview of Research and Development Activities


State of the Science on Spinal Cory Injury


Research Projects: Effect of Local Cooling | Effects of Weight Shifting | Handrim Technology


Development Projects: Inflammation Modeling | Low Shear, Cool Cushion | Propulsion Training Tools


 

R2 Effects of weight shifts on pressure ulcer risk status

Task Leader(s): Kath Bogie, D.Phil

Co-Investigator: Greg Nemunaitis, MD, Melvin Mehia MD

 


Project Overview

A pilot study to determine the effects of passive weight shifting on pressure ulcer risk factors will be carried out using a repeated measure longitudinal study design. A total of 15 wheelchair users with complete spinal cord injury (SCI) will be recruited for this study. Tissue health will be assessed at three month intervals during the 18 month period of study participation.

 


Project Objective(s)

The specific aim of this project is to evaluate the effects of passive weight-shifting produced by an active pressure relief cushion on pressure ulcer risk factors.

 


Methods

Tissue health data is collected using the established laboratory protocol developed by our Skin Care Research Team (SCRT) at the Cleveland DVAMC. This standard assessment is followed by assessment of tissue blood flow using laser Doppler flowmetry.

 


Expected Findings and Deliverables

We anticipate that this research will enhance our understanding of the relative impact of passive and dynamic weight-shifting on pressure ulcer risk factors. This effort will generate several papers to be published in multidisciplinary fields, including clinical rehabilitation, biomedical engineering, physiology and technology. In addition in order to disseminate to professionals in the field, our findings will be presented at national and international meetings including the annual conferences of the American Paraplegia Society (APS) and the International Spinal Cord Society (ISCoS). It is further anticipated that our initial evaluations will be leveraged as preliminary data for larger scale clinical studies of weight-shifting devices. The potential for developing new devices and systems will also be explored.

R2F1 image

 


Project Updates

2012

At this time we have recruited seventeen people into the study to achieve Aim 1. Development of a data analysis technique to facilitate correlation of multiple tissue health measures, specifically tissue oxygen (TcPO2) and tissue blood flow has continued during this reporting period.

Specific Aim 2 was designed to evaluate the synergistic effects of dynamic weight-shifting produced by an implanted gluteal stimulation system combined with an active pressure relief cushion. This arm of the study will employ a pre/post intervention case series design. Subjects to be recruited for Aim 2 will all currently have implanted lower extremity FES systems that include stimulation of the gluteal muscles.

2011

At this time we have recruited fourteen people into the study to achieve Aim 1. Seven participants have completed the study and submitted the Quest 2.b user satisfaction questionnaire. Two active participants have completed the fifth phase of active cushion use. One new participant has been recruited and will start the study on 5/31/11. Four participants have not completed the study: two were lost to follow-up, one did not wish to continue and the other developed an ischial pressure ulcer after the second phase of active cushion use. Recruitment goals for Specific Aim 1 remain on schedule and we do not foresee any problems with meeting recruitment goals. Development of a data analysis technique to facilitate correlation of multiple tissue health measures, specifically tissue oxygen (TcPO2) and tissue blood flow has continued during this reporting period.

Specific Aim 2 was designed to evaluate the synergistic effects of dynamic weight-shifting produced by an implanted gluteal stimulation system combined with an active pressure relief cushion. Due to the withdrawal of NDI Medical from VA research partnerships, we are on hold to develop a fully implanted gluteal stimulation system specifically for pressure ulcer prevention. However, as reported last year, we have other active studies with participants using implanted gluteal stimulation. These FES studies use other technology and incorporate regular use of gluteal stimulation as a component in a larger exercise program, e.g. for balance or postural control. The dynamic weight-shifting stimulation used in these systems is the same as that used in the simpler gluteal stimulation only system. We reported last year that our plan to recruit participants for Specific Aim 2 was to recruit individuals participating in these studies. They first need to receive the implanted stimulation systems and complete all functional assessments for the FES study before being recruited to the RERC R2 study. We anticipated that we could begin recruitment for this study the 3rd quarter of 2010. However, due to delay in obtaining regulatory approval for an IDE for the new implanted system from the FDA, the study population for Aim 2 has not been available.

Because recruitment for Specific Aim 2 has been delayed, we will carry out one-time assessments of these participants rather than a repeated measures study. We will recruit people with existing implanted stimulation systems. These systems incorporate gluteal stimulation as a component in a larger exercise program, e.g. for standing or postural control. These individuals will have a weight-shifting pattern programmed for the purpose of evaluation in this study. We interact regularly with these individual who currently have implanted stimulation systems and do not foresee any problems in recruiting them to the RERC R2 study. In addition, people who receive the new implanted systems will be recruited to the study.

2010

At this time we have thirteen people enrolled in the study. Four participants have completed the study and submitted the Quest 2.b user satisfaction questionnaire. Seven participants have completed one or more phases of active cushion use (see below for details). Two participants dropped out of the study. One was lost to follow-up and the other developed an ischial pressure ulcer after the second phase of active cushion use.

One (1) participant has completed the fifth phase of active cushion use.
One (1) participant has completed the fourth phase of active cushion use.
Two (2) participants have completed the third phase of active cushion use.
Two (2) participants have completed the second phase of active cushion use.
One (1) participant has completed the first phase of active cushion use

Recruitment goals for Specific Aim 1 remain on schedule and we do not foresee any problems with meeting recruitment goals.

Specific Aim 2 will evaluate the synergistic effects of dynamic weight-shifting produced by an implanted gluteal stimulation system combined with an active pressure relief cushion. Due to the withdrawal of NDI Medical from VA research partnerships, we are on hold to develop a fully implanted gluteal stimulation system specifically for pressure ulcer prevention. However, we have other active studies with participants using implanted gluteal stimulation. These FES studies use other technology and incorporate regular use of gluteal stimulation as a component in a larger exercise program, e.g. for balance or postural control. The dynamic weight-shifting stimulation used in these systems is the same as that used in the simpler gluteal stimulation only system.

In order to recruit participants for Specific Aim 2, we will recruit individuals participating in these studies. They will receive implanted stimulation systems and complete all functional assessments for the FES study before being recruited to the RERC R2 study. Based on the timeline for these associated studies, we will commence recruitment for the second arm of the study in the 3rd quarter of 2010. Therefore, recruitment for Specific Aim 2 has been shifted as participants must complete activities in other studies prior to enrollment in the RERC R2 protocol. We will be interacting regularly with these individuals prior to enrollment and do not foresee any problems in recruiting them to the RERC R2 study.

A data analysis technique is being developed to facilitate correlation of multiple tissue health measures, specifically tissue oxygen (TcPO2) and tissue blood flow.

2009

Following initial regulatory and administrative approval of the project, obtained at the end of May 2008, enrollment to the study was opened in June 2008. At this time we have nine people recruited to the study. Five participants have completed one or more phases of active cushion use. One participant is in the interval between baseline and first phase of active cushion use. Three further study participants have completed the screening process and baseline assessments are being scheduled. A data analysis technique is being developed to facilitate correlation of multiple tissue health measures, specifically tissue oxygen (TcPO2) and tissue blood flow.

2008

Two study participants have been recruited and baseline assessments have been completed. They are currently using the cushion and will be returning for their first intervention assessments.
Two further subjects have been recruited and will be scheduled for baseline assessments.
We are collecting tissue health data using the established laboratory protocol developed by our Skin Care Research Team (SCRT) at the Cleveland DVAMC. This standard assessment is followed by assessment of tissue blood flow using laser Doppler flowmetry.
A poster on the study was presented at the MetroHealth Research Festival, Cleveland OH on September 25th, 2008

 


Publications

Wu GA, Mejia, M, Nemunaitis G, Bogie K. Pressure ulcer risk after use of an active pressure cushion, Poster presentation at MetroHealth Medical Center Research Day, September, 2009.

Wu GA, Bogie K. Determining the effects of a dynamic cushion for at-risk users using a multi-factorial tissue health assessment protocol, Poster presentation at Research ShowCASE at Case Western Reserve University, April, 2010.

Wu GA, Bogie K. Multi-factorial tissue health assessment protocol: Determining the effects of a dynamic cushion for at-risk users, Poster presentation at 17th Congress of the European Society of Biomechanics in Edinburgh Scotland, UK, July, 2010.

Wu G, Mejia M, Nemunaitis G, Bogie K. (2010). Multi-factorial Approach to Determine Effects of Weight Shifting With a Dynamic Cushion on Tissue Health of At-Risk Users. MetroHealth Medical Center Research Day.

Wu G, Mejia M, Nemunaitis G, Bogie KM (2011). Multifactorial tissue health assessment of at-risk users and effects of weight shifting with a dynamic cushion. Topics in Spinal Cord Injury Rehabilitation, 16.1, 29.

Wu, G.; Bogie, K.; Nemunaitis, G.; Mejia, M. (2011). Tissue Health Effects of a Dynamic Cushion for Pressure Redistribution in Persons with SCI: Oxygenation and Component Analysis of Blood Flow. MetroHealth Medical Center Research Day.

Wu, G.; Bogie, K. (2012). Comparison of The Effects of Conventional Weight-Shifting and Dynamic Wheelchair Cushions Using a Multi-Factorial Tissue Health Assessment Protocol. Proceedings of the 2012 RESNA Conference. Baltimore, MD: RESNA Press.  

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This work is funded by the National Institute on Disability and Rehabilitation Research (NIDRR),
Rehabilitation Engineering Research Center (RERC) on Spinal Cord Injury, Grant #H133E070024
The ideas and opinions expressed herein are those of the authors and not necessarily reflective of the NIDRR.

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Last Updated: 07.10.2012 | 16:10

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