Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI
13 juni 2019 uppdaterad av: Melissa M. Morrow, Ph.D., Mayo Clinic
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).
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
19
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Minnesota
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Intervention
Two interventions will be provided.
The first intervention is a structured education regarding pressure ulcer prevention through weight shifts at start of study.
The second intervention is the use of a mobile seat interface pressure map (IPM), which will occur during two intervention phases.
|
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.
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Trunk Movement
Tidsram: 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.
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total Vector Magnitude of Movement
Tidsram: 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.
|
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.
|
|
Forward and Lateral Tilt
Tidsram: 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.
|
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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Melissa MB Morrow, PhD, Mayo Clinic
- Huvudutredare: Tamara L Vos-Draper, PhD, University of Minnesota
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Krause JS. Skin sores after spinal cord injury: relationship to life adjustment. Spinal Cord. 1998 Jan;36(1):51-6. doi: 10.1038/sj.sc.3100528.
- 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. doi: 10.1191/0269215503cr692oa.
- 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.
- Akins JS, Karg PE, Brienza DM. Interface shear and pressure characteristics of wheelchair seat cushions. J Rehabil Res Dev. 2011;48(3):225-34. doi: 10.1682/jrrd.2009.09.0145.
- 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. doi: 10.1080/10790268.2009.11760750.
- 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. doi: 10.1097/00002060-198806000-00007.
- 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.
- Staas WE Jr, Cioschi HM. Pressure sores--a multifaceted approach to prevention and treatment. West J Med. 1991 May;154(5):539-44.
- 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. doi: 10.3949/ccjm.68.8.704.
- 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.
- 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.
- 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. doi: 10.1080/10790268.2001.11753592. No abstract available.
- 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. doi: 10.1016/j.apmr.2006.08.329.
- 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. doi: 10.5014/ajot.63.3.301.
- Stinson MD, Porter-Armstrong AP, Eakin PA. Pressure mapping systems: reliability of pressure map interpretation. Clin Rehabil. 2003 Aug;17(5):504-11. doi: 10.1191/0269215503cr643oa.
- 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. doi: 10.1191/0269215505cr826oa.
- Norman D. Measuring interface pressure: validity and reliability problems. J Wound Care. 2004 Feb;13(2):78-80. doi: 10.12968/jowc.2004.13.2.26576.
- 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. doi: 10.1682/jrrd.2010.05.0102.
- 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. doi: 10.1053/apmr.2001.21854.
- 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. doi: 10.5014/ajot.56.2.185.
- 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.
- 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. doi: 10.1682/jrrd.2007.03.0046.
- 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. doi: 10.1016/j.apmr.2004.08.010.
- Eitzen I. Pressure mapping in seating: a frequency analysis approach. Arch Phys Med Rehabil. 2004 Jul;85(7):1136-40. doi: 10.1016/j.apmr.2003.09.007.
- 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.
- 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.
- 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. doi: 10.1682/jrrd.2007.06.0089.
- 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.
- 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.
- 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.
- Sprigle S, Dunlop W, Press L. Reliability of bench tests of interface pressure. Assist Technol. 2003 Summer;15(1):49-57. doi: 10.1080/10400435.2003.10131889.
- 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.
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
14 februari 2017
Primärt slutförande (Faktisk)
11 september 2017
Avslutad studie (Faktisk)
11 september 2017
Studieregistreringsdatum
Först inskickad
11 juni 2019
Först inskickad som uppfyllde QC-kriterierna
13 juni 2019
Första postat (Faktisk)
14 juni 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 juni 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 juni 2019
Senast verifierad
1 juni 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 16-007531
- 1R21AG050640-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Ryggmärgsskador
-
Herlev and Gentofte HospitalRekrytering
-
Weill Medical College of Cornell UniversityRekryteringTethered Cord Syndrome | Tjudd sladd | Spina Bifida Occulta | Ockult Spina BifidaFörenta staterna
-
Xuanwu Hospital, BeijingChinese PLA General Hospital; The First Hospital of Hebei Medical University och andra samarbetspartnersHar inte rekryterat ännuÅterkommande vuxen Tethered Cord SyndromeKina
-
Tehran University of Medical SciencesOkändTumör | Tethered Cord Syndrome | Fibrolipom av Filum Terminale | Lipomyelomeningocele | Missbildning av delad sladd | Dermal sinusIran, Islamiska republiken
-
University of VersaillesAvslutadCentral ryggmärgssyndrom | Central Cord Injury SyndromeFrankrike
-
Rambam Health Care CampusAvslutadIntrassling av fostersträngenIsrael
-
University of Texas Southwestern Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AvslutadAkut pung | TestikeltorsionFörenta staterna
-
University of VirginiaRekryteringUrologiska sjukdomar | Myelomeningocele | Neurogen blåsan | Tethered Cord Syndrome | Blåsa, neurogen | Neurologisk dysfunktionFörenta staterna
-
Centre Hospitalier Universitaire, AmiensAvslutadBarn | Diagnos | NIRS | Testikeltorsion | Diagnostiskt testFrankrike
Kliniska prövningar på Structured Pressure Ulcer Prevention Education
-
University of MalayaAvslutadTryckskada | Begränsning, rörlighetMalaysia
-
Wake Forest University Health SciencesPatient-Centered Outcomes Research Institute; Atrium Health Levine Cancer...AvslutadSicklecellanemiFörenta staterna
-
West Chester University of PennsylvaniaAvslutadFörebyggande av röststörningar hos lärarstudenterFörenta staterna
-
Centers for Disease Control and PreventionColorado Department of Public Health and Environment; San Francisco Department... och andra samarbetspartnersAvslutadSexuellt överförbara sjukdomar | HIV