Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI
13 de junho de 2019 atualizado por: 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).
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
19
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: 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.
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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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Trunk Movement
Prazo: 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.
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The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement.
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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.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Total Vector Magnitude of Movement
Prazo: 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.
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The vector magnitude for each second of data during wear-times will be classified as a period of activity or inactivity.
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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.
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Forward and Lateral Tilt
Prazo: 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.
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Forward and lateral tilt will be assessed with the raw triaxial accelerometer data by determining the angles between gravity and the off-axes
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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.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Melissa MB Morrow, PhD, Mayo Clinic
- Investigador principal: Tamara L Vos-Draper, PhD, University of Minnesota
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
14 de fevereiro de 2017
Conclusão Primária (Real)
11 de setembro de 2017
Conclusão do estudo (Real)
11 de setembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
11 de junho de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de junho de 2019
Primeira postagem (Real)
14 de junho de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de junho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de junho de 2019
Última verificação
1 de junho de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 16-007531
- 1R21AG050640-01A1 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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