Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI

Spinal Cord Injuries Clinical Trial

Official title:

Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987243
• Other study ID #: 16-007531
• Secondary ID: 1R21AG050640-01A
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: September 11, 2017

Study information

• Verified date: June 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine two interventions to increase weight shifts, overall trunk movement, and self‐efficacy related to pressure ulcer prevention in wheelchair users with a spinal cord injury (SCI).

Description:

Participants will use a mobile seat interface pressure mapping system that gives them live, real‐time, visual feedback on the distribution of pressure between them and their seat cushion. This type of feedback works as a compensatory strategy for lack of sensation and allows the individual to visually observe pressure distribution they are not able to feel. Additionally, the participants will be provided with structured pressure ulcer prevention education, grounded in the principles of social cognitive theory, regarding pressure ulcer risk and use of weight shifts.

The pressure mapping system, which will be used during training, provides virtual modeling of the desired outcome (reduced pressure) and is an important part of the education module.

The findings of this study will inform clinicians and investigators of whether use of mobile seat interface pressure mapping as a compensatory‐based intervention has a positive impact on trunk movement and self‐efficacy for completing weight shifts in wheelchair users who lack sensation. Another contribution of this work is an exploration of the relationship between self‐efficacy and movement in wheelchair users.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 11, 2017
• Est. primary completion date: September 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Individuals with a spinal cord injury (C4 and below, traumatic or non-traumatic, with onset greater than 12 months at enrollment)

• Individuals who use a wheelchair as their primary form of mobility

• Individuals who are willing to participate and able to make 2 visits to the Mayo Clinic in Rochester, MN

Exclusion Criteria:

• Documented active pressure ulcer of any stage at initiation of study

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Behavioral:
• Structured Pressure Ulcer Prevention Education
Structured education for performance weight shift maneuvers and pressure ulcer prevention will occur during the initial visit for each subject. The education method used aligns with principles of the social cognitive theory to facilitate learning. The purpose in providing the education is to ensure all of the participants receive uniform instruction in how to perform weight shifts and to facilitate understanding of the importance of completing them as a protective measure against pressure ulcer development. Because each participant will come into the study at varying levels of understanding about pressure ulcer risk and knowledge of how to complete weight shift maneuvers, the education component is critical to ensure all participants are provided with the same information in the same way.

Other:
• Mobile Seat Interface Pressure Mapping System (IPM)
This mobile IPM system was designed to provide visual information about seat interface pressure distribution to compensate for lack of sensation on the sitting surface. This variable will be toggled on and off between the intervention and control phases of the study. The participants will have access to the visual feedback while learning how to complete weight shift maneuvers at the initial visit and then again at home during the intervention phases (weeks 2 and 4). During the control phases (weeks 1 and 3), they will not have access to the visual feedback from the pressure map

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Aging (NIA), University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (33)

Akins JS, Karg PE, Brienza DM. Interface shear and pressure characteristics of wheelchair seat cushions. J Rehabil Res Dev. 2011;48(3):225-34. — View Citation

Barnett RI, Shelton FE 4th. Measurement of support surface efficacy: pressure. Adv Wound Care. 1997 Nov-Dec;10(7):21-9. Erratum in: Adv Wound Care 1998 Mar-Apr;11(2):94. — View Citation

Bates-Jensen BM, Guihan M, Garber SL, Chin AS, Burns SP. Characteristics of recurrent pressure ulcers in veterans with spinal cord injury. J Spinal Cord Med. 2009;32(1):34-42. — View Citation

Bogie K, Wang X, Fei B, Sun J. New technique for real-time interface pressure analysis: getting more out of large image data sets. J Rehabil Res Dev. 2008;45(4):523-35, 10 p following 535. — View Citation

Brienza DM, Karg PE, Geyer MJ, Kelsey S, Trefler E. The relationship between pressure ulcer incidence and buttock-seat cushion interface pressure in at-risk elderly wheelchair users. Arch Phys Med Rehabil. 2001 Apr;82(4):529-33. — View Citation

Clark FA, Jackson JM, Scott MD, Carlson ME, Atkins MS, Uhles-Tanaka D, Rubayi S. Data-based models of how pressure ulcers develop in daily-living contexts of adults with spinal cord injury. Arch Phys Med Rehabil. 2006 Nov;87(11):1516-25. — View Citation

Consortium for Spinal Cord Medicine Clinical Practice Guidelines. Pressure ulcer prevention and treatment following spinal cord injury: a clinical practice guideline for health-care professionals. J Spinal Cord Med. 2001 Spring;24 Suppl 1:S40-101. — View Citation

Crawford SA, Stinson MD, Walsh DM, Porter-Armstrong AP. Impact of sitting time on seat-interface pressure and on pressure mapping with multiple sclerosis patients. Arch Phys Med Rehabil. 2005 Jun;86(6):1221-5. — View Citation

Crawford SA, Strain B, Gregg B, Walsh DM, Porter-Armstrong AP. An investigation of the impact of the Force Sensing Array pressure mapping system on the clinical judgement of occupational therapists. Clin Rehabil. 2005 Mar;19(2):224-31. — View Citation

Dunn CA, Carlson M, Jackson JM, Clark FA. Response factors surrounding progression of pressure ulcers in community-residing adults with spinal cord injury. Am J Occup Ther. 2009 May-Jun;63(3):301-9. — View Citation

Eitzen I. Pressure mapping in seating: a frequency analysis approach. Arch Phys Med Rehabil. 2004 Jul;85(7):1136-40. — View Citation

Fortune E, Lugade V, Morrow M, Kaufman K. Validity of using tri-axial accelerometers to measure human movement - Part II: Step counts at a wide range of gait velocities. Med Eng Phys. 2014 Jun;36(6):659-69. doi: 10.1016/j.medengphy.2014.02.006. Epub 2014 Mar 20. — View Citation

Fuhrer MJ, Garber SL, Rintala DH, Clearman R, Hart KA. Pressure ulcers in community-resident persons with spinal cord injury: prevalence and risk factors. Arch Phys Med Rehabil. 1993 Nov;74(11):1172-7. — View Citation

Jackson J, Carlson M, Rubayi S, Scott MD, Atkins MS, Blanche EI, Saunders-Newton C, Mielke S, Wolfe MK, Clark FA. Qualitative study of principles pertaining to lifestyle and pressure ulcer risk in adults with spinal cord injury. Disabil Rehabil. 2010;32(7):567-78. doi: 10.3109/09638280903183829. — View Citation

Krause JS. Skin sores after spinal cord injury: relationship to life adjustment. Spinal Cord. 1998 Jan;36(1):51-6. — View Citation

Lugade V, Fortune E, Morrow M, Kaufman K. Validity of using tri-axial accelerometers to measure human movement - Part I: Posture and movement detection. Med Eng Phys. 2014 Feb;36(2):169-76. doi: 10.1016/j.medengphy.2013.06.005. Epub 2013 Jul 27. — View Citation

Maurer CL, Sprigle S. Effect of seat inclination on seated pressures of individuals with spinal cord injury. Phys Ther. 2004 Mar;84(3):255-61. — View Citation

Mawson AR, Biundo JJ Jr, Neville P, Linares HA, Winchester Y, Lopez A. Risk factors for early occurring pressure ulcers following spinal cord injury. Am J Phys Med Rehabil. 1988 Jun;67(3):123-7. — View Citation

Niazi ZB, Salzberg CA, Byrne DW, Viehbeck M. Recurrence of initial pressure ulcer in persons with spinal cord injuries. Adv Wound Care. 1997 May-Jun;10(3):38-42. — View Citation

Norman D. Measuring interface pressure: validity and reliability problems. J Wound Care. 2004 Feb;13(2):78-80. Review. — View Citation

Pipkin L, Sprigle S. Effect of model design, cushion construction, and interface pressure mats on interface pressure and immersion. J Rehabil Res Dev. 2008;45(6):875-82. — View Citation

Raghavan P, Raza WA, Ahmed YS, Chamberlain MA. Prevalence of pressure sores in a community sample of spinal injury patients. Clin Rehabil. 2003 Dec;17(8):879-84. — View Citation

Reenalda J, Jannink M, Nederhand M, IJzerman M. Clinical use of interface pressure to predict pressure ulcer development: a systematic review. Assist Technol. 2009 Summer;21(2):76-85. doi: 10.1080/10400430903050437. Review. — View Citation

Saunders LL, Krause JS, Acuna J. Association of race, socioeconomic status, and health care access with pressure ulcers after spinal cord injury. Arch Phys Med Rehabil. 2012 Jun;93(6):972-7. doi: 10.1016/j.apmr.2012.02.004. Epub 2012 Apr 10. — View Citation

Sprigle S, Dunlop W, Press L. Reliability of bench tests of interface pressure. Assist Technol. 2003 Summer;15(1):49-57. — View Citation

Sprigle S, Sonenblum S. Assessing evidence supporting redistribution of pressure for pressure ulcer prevention: a review. J Rehabil Res Dev. 2011;48(3):203-13. Review. — View Citation

Staas WE Jr, Cioschi HM. Pressure sores--a multifaceted approach to prevention and treatment. West J Med. 1991 May;154(5):539-44. — View Citation

Stinson M, Porter A, Eakin P. Measuring interface pressure: a laboratory-based investigation into the effects of repositioning and sitting. Am J Occup Ther. 2002 Mar-Apr;56(2):185-90. — View Citation

Stinson M, Schofield R, Gillan C, Morton J, Gardner E, Sprigle S, Porter-Armstrong A. Spinal cord injury and pressure ulcer prevention: using functional activity in pressure relief. Nurs Res Pract. 2013;2013:860396. doi: 10.1155/2013/860396. Epub 2013 Apr 9. — View Citation

Stinson MD, Porter-Armstrong AP, Eakin PA. Pressure mapping systems: reliability of pressure map interpretation. Clin Rehabil. 2003 Aug;17(5):504-11. — View Citation

Thietje R, Giese R, Pouw M, Kaphengst C, Hosman A, Kienast B, van de Meent H, Hirschfeld S. How does knowledge about spinal cord injury-related complications develop in subjects with spinal cord injury? A descriptive analysis in 214 patients. Spinal Cord. 2011 Jan;49(1):43-8. doi: 10.1038/sc.2010.96. Epub 2010 Sep 7. — View Citation

Thomas DR. Prevention and treatment of pressure ulcers: what works? what doesn't? Cleve Clin J Med. 2001 Aug;68(8):704-7, 710-14, 717-22. Review. — View Citation

Verschueren JH, Post MW, de Groot S, van der Woude LH, van Asbeck FW, Rol M. Occurrence and predictors of pressure ulcers during primary in-patient spinal cord injury rehabilitation. Spinal Cord. 2011 Jan;49(1):106-12. doi: 10.1038/sc.2010.66. Epub 2010 Jun 8. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trunk Movement	The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement.	For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
Secondary	Total Vector Magnitude of Movement	The vector magnitude for each second of data during wear-times will be classified as a period of activity or inactivity.	For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
Secondary	Forward and Lateral Tilt	Forward and lateral tilt will be assessed with the raw triaxial accelerometer data by determining the angles between gravity and the off-axes	For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.

External Links

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