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Spinal Cord Injury Energy Management Program

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ClinicalTrials.gov Identifier: NCT01184365
Recruitment Status : Completed
First Posted : August 18, 2010
Last Update Posted : March 17, 2014
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:

Fatigue is a common complaint of persons with spinal cord injury (SCI) that negatively affects physical function, participation in daily activities, employment, and community involvement. No behavioural intervention for fatigue has been reported for SCI, though the benefits of such programs have been proven in persons with neurological conditions like multiple sclerosis and arthritis. Based on a study with people with SCI, an energy management program (EnMP-1) was developed. The focus of this study is to test EnMP-1. Adults with SCI living in the community and reporting fatigue as a problem will participate in the program.

Hypothesis: Participants in the EnMP-1 group will show significantly lower fatigue impact scores and higher self-efficacy scores immediately after, 3 months, and 6 months post-intervention than EnMP-2 participants.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Behavioral: Energy Management Program Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Spinal Cord Injury Energy Management Program
Study Start Date : August 2010
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: EnMP-1
The goal of the EnMP-1 is to enable participants, through a behavioural, psycho-educational intervention, to better manage and understand their fatigue. This program is provided in four, two-hour sessions held weekly.
Behavioral: Energy Management Program
The program content over the four sessions is structured as follows: Session 1 is an introduction to the group, important concepts, and upcoming session topics; Session 2 further elaborates on the concepts introduced in session 1 and encourages self-reflection; Session 3 is the peer to peer contact by phone or in person to assist with problems and share tips that really worked; and Session 4 concludes the program and serves to consolidate information learned.
Active Comparator: EnMP-2
The goal of the EnMP-2 is to control for group effects
Behavioral: Energy Management Program
The goal of the EnMP-2 is to control for group effects

Primary Outcome Measures :
  1. To test a behavioural (not pharmaceutical or surgical) intervention for fatigue in SCI [ Time Frame: Six months ]
    The primary outcome measure evaluates fatigue impact and is the Modified Fatigue Impact Scale (MFIS-SCI) which was originally developed for individuals with MS and was modified and tested by members of the research team in a study of fatigue in a sub-acute sample of individuals with SCI.

Secondary Outcome Measures :
  1. Evaluates self-efficacy and is the Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA) [ Time Frame: Six months ]
    The measure consists of items regarding confidence in employing various means of energy conservation and is answered on a scale of 1-10, with one being not at all confident to ten being completely confident.

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • must reside in the community in the Lower Mainland of Vancouver, British Columbia, Canada
  • must be an adult (19-65 years old)
  • be English speaking
  • have a spinal cord injury and is living in the community
  • experiencing problems with managing energy that may or may not result in difficulty participating at home, work or in the community.

Exclusion Criteria:

  • have a severe brain injury that may prevent their participation in the study
  • have other conditions such as arthritis, multiple sclerosis, cancer, or anemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184365

Canada, British Columbia
Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Susan J. Forwell, PhD, OT(C), FCAOT University of British Columbia
Study Director: William C. Miller, Dr. University of British Columbia
Study Director: Andrea Townson, Dr. University of British Columbia
Study Director: Karen Hammell, Dr. University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01184365     History of Changes
Other Study ID Numbers: H10-01037
NSP-104021 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014

Keywords provided by University of British Columbia:
energy management
spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System