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Interdisciplinary Pressure Management & Mobility Program as an Alternative to Usual Care: A Pilot Study (WOUND)
This study is currently recruiting participants.
Verified by University of Western Ontario, Canada, November 2008
Sponsors and Collaborators: University of Western Ontario, Canada
Ontario Neurotrauma Foundation
Information provided by: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT00796042
  Purpose

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
Pressure Ulcer
Other: Usual care
Other: Pressure management and Mobility program
Phase III

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources
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

Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • Wound healing: We will measure changes in wound size and appearance using acetate tracings with Visatrak system, digital photography, and the Photographic wound assessment tool (PWAT). [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost Effectiveness [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]
  • Quality of Life (SF-12 and Cardiff Wound Impact Questionnaire) [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]
  • Motor Performance (Canadian Occupational Performance Measure (COPM)), [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]
  • Secondary complications [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]
  • Caregiver Burden [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]
  • Compliance (diary) [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2008
Estimated Study Completion Date: August 2009
Arms Assigned Interventions
1: Active Comparator
Usual Care
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.
2: Experimental
Individualized, Community-based, Pressure management and Mobility program:
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (18-80 yrs) with a spinal cord injury (SCI) resulting in quadriplegia or paraplegia
  • Stage II-IV pressure ulcer located anywhere on the body that is likely to heal over the 6 month study period.
  • Requires a wheelchair for locomotion
  • Able to travel to local wound centre to undergo detailed wound and medical assessment that includes blood analysis and wound culture.
  • Provides consent to access relevant medical records.
  • Able to adhere with study protocol, pressure management and mobility program, wound care protocol, and evaluation procedures for 8 month study period.

Exclusion Criteria:

  • Unable to achieve adequate pressure relief using available resources provided by research study.
  • Stage IV deep pressure sore +/- osteomyelitis that requires surgical closure.
  • Medically unstable or has or any other medical condition that would prevent the individual from sitting in wheelchair for at least 2 hours (e.g. Orthostatic hypotension).
  • Has a limited life expectancy that is not sufficient to complete the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796042

Contacts
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

Locations
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            
Sponsors and Collaborators
University of Western Ontario, Canada
Ontario Neurotrauma Foundation
Investigators
Principal Investigator: Pamela Houghton, BScPT, PhD University of Western Ontario, Canada
Principal Investigator: Linda Norton, OT (Reg) Shoppers Home Health Care
  More Information

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  
Health Authority: Canada: Health Canada;   Canada: Ethics Review Committee

Keywords provided by University of Western Ontario, Canada:
Pressure Ulcer
Bed Sores
Bedsore
Decubitus Ulcer
Pressure Sore
Best rest
mobility
pressure management

Study placed in the following topic categories:
Skin Diseases
Ulcer
Skin Ulcer
Pressure Ulcer

ClinicalTrials.gov processed this record on January 15, 2009