Interdisciplinary Pressure Management & Mobility Program as an Alternative to Usual Care: A Pilot Study

NCT00796042 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-06-05

No results posted yet for this study

Summary

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.

Conditions

  • Pressure Ulcer

Interventions

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.

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.

Sponsors & Collaborators

  • Ontario Neurotrauma Foundation

    collaborator OTHER
  • University of Western Ontario, Canada

    lead OTHER

Principal Investigators

  • Pamela Houghton, BScPT, PhD · Western University, Canada

  • Linda Norton, OT (Reg) · Shoppers Home Health Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00796042 on ClinicalTrials.gov