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Sponsors and Collaborators: |
University of Western Ontario, Canada Ontario Neurotrauma Foundation |
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Information provided by: | University of Western Ontario, Canada |
ClinicalTrials.gov Identifier: | NCT00796042 |
People with spinal cord injuries posses many factors that increase their risk of developing pressure ulcers. Not surprisingly, approximately 82% of persons with spinal cord injury (SCI) will experience a pressure ulcer at sometime during their life. Earlier guidelines for the assessment and treatment of pressure ulcers produced by RNAO in 20027 recommended that "a client who has a pressure ulcer on a seating surface should avoid sitting." Unfortunately, this recommendation has fueled the long standing view that people with pressure ulcers should stop using their wheelchairs and return to bed. The strength of evidence assigned for this recommendation was Level=C reflecting the paucity of research evidence to support this common practice.
Not only do the benefits of bed rest on healing remain to be demonstrated, there is mounting evidence that bed rest can be harmful to a person's overall health and well being. Bed rest has been shown to be strongly associated with complications in most body systems including respiratory, cardiovascular, musculoskeletal, cerebrovascular, gastrointestinal, and genital-urinary. Psychosocial complications and cognitive impacts are also well documented.
Without evidence to dispel the myth that "bed rest is best" it will be difficult to change practice and avoid many of the secondary complications. This study is a pilot study to 1) determine whether pressure ulcers heal faster in individuals with SCI who receive an individualized community-based, pressure management and mobility program compared to a similar group assigned to usual care (bed rest), 2) determine the strength of the association between the intervention (pressure/mobility or bedrest) and wound healing, motor performance/independence and quality of life while adjusting for motivation to regain independence, degree of caregiver burden, and compliance with the intervention, 3) determine whether individuals with SCI who participate in a pressure/mobility management program experience fewer secondary complications than those who do not participate, 4) determine the cost-effectiveness of providing a time-efficient, pressure management and mobility program compared to bed rest.
Condition | Intervention | Phase |
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Pressure Ulcer |
Other: Usual care Other: Pressure management and Mobility program |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Interdisciplinary Pressure Management & Mobility Program as an Alternative to Bed Rest: A Pilot Study |
Estimated Enrollment: | 20 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | August 2009 |
Arms | Assigned Interventions |
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1: Active Comparator
Usual Care
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Other: Usual care
Subjects will be encouraged to implement the standard wound care protocol that is consistent with the National (CAWC) and Provincial (RNAO) best practice guidelines for the treatment of pressures ulcers. This wound care program will be customized to subject's needs based on the results of the assessment performed by the wound care specialist. A registered dietitian will review blood values associated with nutritional status and make recommendations for dietary changes. Wherever possible, implementation of this wound care program will be coordinated with the subjects' current health care team and appropriate referrals to home care agencies or specialists will be initiated where needed. Subjects assigned to this group will continue their current level of activity (bed rest). Any equipment or services will be obtained through the usual provider agencies.
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2: Experimental
Individualized, Community-based, Pressure management and Mobility program:
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Other: Pressure management and Mobility program
Subjects are provided with the same customized wound care program as the usual care group and a pressure management and mobility program that is customized to the individual's needs. This program is based on an in depth home assessment performed by a registered Occupational (OT) or Physical Therapist (PT). Pressure Management Program: A qualified OT or PT will examine the subject on all in-use surfaces and observe all transfers to identify sources of friction and shear, and any strength or balance deficits, identifying what equipment/services are required to manage pressure, improve mobility, and reduce friction and shear. Mobility Program: A qualified PT will assess strength, balance, range of motion, and functional independence with transfers and other ADLs and will develop a mobility program to optimize functional independence and improve strength and balance required for safe and effective transfers. Program to be implemented within one month of this evaluation.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Orthostatic hypotension).
Contact: Pamela Houghton, BScPT, PhD | 519-661-2111 ext 88862 | phoughto@uwo.ca |
Contact: Dianne Bryant, MSc, PhD | 519-661-2111 ext 83947 | dianne.bryant@uwo.ca |
Canada, Ontario | |
Women's College Hospital & Mississauga Dermatology Clinic | Recruiting |
Toronto & Mississauga, Ontario, Canada | |
Contact: Linda Norton, OT (Reg) | |
Sub-Investigator: Gary Sibbald, MD, FRCPC, MACP, DABD | |
Principal Investigator: Linda Norton, OT (Reg) | |
Sub-Investigator: Patricia Coutts, RN | |
Sub-Investigator: Kevin Woo, RN, ACNP, GNG(c), MSc | |
Sub-Investigator: Gail Woodbury, BScPT, MSc, PhD | |
University of Western Ontario | Recruiting |
London, Ontario, Canada | |
Contact: Pamela Houghton, BScPT, PhD 519-661-2111 ext 88862 phoughto@uwo.ca | |
Contact: Dianne Bryant, MSc, PhD 519-661-2111 ext 83947 dianne.bryant@uwo.ca | |
Principal Investigator: Pamela Houghton, BScPT, PhD | |
Sub-Investigator: Dianne Bryant, MSc, PhD | |
Sub-Investigator: Chris Fraser, HBSc |
Principal Investigator: | Pamela Houghton, BScPT, PhD | University of Western Ontario, Canada |
Principal Investigator: | Linda Norton, OT (Reg) | Shoppers Home Health Care |
Responsible Party: | Shoppers Home Health Care & University of Western Ontario ( Linda Norton/ OT Reg. (ONT) & Pamela Houghton/ BScPT, PhD ) |
Study ID Numbers: | ONF-2004-SCI-SC-01, ONF-2004-SCI-SC-01 |
Study First Received: | November 21, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00796042 History of Changes |
Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee |
Pressure Ulcer Bed Sores Bedsore Decubitus Ulcer |
Pressure Sore Best rest mobility pressure management |
Skin Diseases Ulcer Skin Ulcer Pressure Ulcer |
Skin Diseases Skin Ulcer Pressure Ulcer |