Study to Assess the Validity and Reliability of the Spinal Cord Independence Measure (SCIM III)
NCT ID: NCT00573976
Last Updated: 2010-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
660 participants
OBSERVATIONAL
2007-09-30
2010-09-30
Brief Summary
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A panel of SCI researchers recommended the SCIM as the most suitable among four candidate measures of functional recovery reviewed at a special meeting sponsored by the National Institute on Disability and Rehabilitation Research (NIDRR) at a joint meeting of the American Spinal Injury Association and the International Spinal Cord Society (ASIA-ISCoS) in Boston, MA, in June 2006. It was recommended that a large-scale, multi-center, prospective trial be conducted in the United States, which would mirror a recently published multi-site international study.
The proposed research on the SCIM III, the latest and most sensitive version of the SCIM, would test the hypothesis that the SCIM III is a valid, reliable, and sensitive measure of functional ability in persons with SCI. Twenty-two rehabilitation centers throughout the United States will enroll a maximum of 660 subjects. Functional ability will be measured with the SCIM III during the first week of admittance into inpatient acute rehabilitation and within one week of discharge from the same rehabilitation program. Statistical analyses will be used to test the validity, reliability, and sensitivity of the SCIM III. The results will demonstrate whether the SCIM III is a suitable outcome measure to assess SCI specific functional ability in future clinical trials.
Detailed Description
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Aims and Hypothesis:
Overall hypothesis - The SCIM III is a valid, reliable, and sensitive measure of functional ability in persons with SCI.
Aim 1: Examine the validity of the SCIM III as an outcome measure to assess functional ability in persons with SCI.
1. Criterion-related validity
2. Construct validity of components
Aim 2: Examine the reliability of SCIM III evaluations.
1. Inter-rater reliability
2. Internal consistency
Aim 3: Examine the sensitivity of the SCIM III to functional change.
1. Sensitivity to functional change compared to the Functional Independence Measure (FIM).
2. Sensitivity to functional change over time
STUDY DESIGN This is a multi-center, prospective clinical research study performed to assess the validity, reliability, and sensitivity of the Spinal Cord Independence Measure (SCIM III) in measuring functional ability in persons with spinal cord injury (SCI).
UCI will act as the coordinating center for this study, collecting and performing statistical data analysis. There will be approximately 22 rehabilitation centers participating in this study. De-identified data will be transferred from these sites to Dr. Kim Anderson at UCI.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Traumatic or non-traumatic cause of spinal injury
* ASIA Impairment Scale grade A, B, C, or D
* Males and females 18 years of age or older
Exclusion Criteria
* Any additional condition, other than SCI and SCI-related secondary conditions, that may influence everyday function
18 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
University of Texas Southwestern Medical Center
OTHER
Rancho Los Amigos National Rehabilitation Center
OTHER
University of Missouri-Columbia
OTHER
James A. Haley Veterans Administration Hospital
FED
VA Long Beach Healthcare System
FED
Allina Health System
OTHER
University of Kentucky
OTHER
Mayo Clinic
OTHER
University of Louisville
OTHER
Shirley Ryan AbilityLab
OTHER
Wake Forest University Health Sciences
OTHER
Kessler Foundation
OTHER
MedStar National Rehabilitation Network
OTHER
MetroHealth Rehabilitation Institute of Ohio
UNKNOWN
Touro Rehabilitation Center
UNKNOWN
Icahn School of Medicine at Mount Sinai
OTHER
Medical College of Wisconsin
OTHER
Unity Health Toronto
OTHER
Thomas Jefferson University
OTHER
The Institute for Rehabilitaion and Research Foundation
OTHER
University of California, Irvine
OTHER
Responsible Party
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University of California, Irvine
Principal Investigators
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Kimberly D Anderson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Other Identifiers
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2007-5854
Identifier Type: -
Identifier Source: secondary_id
OCRT07019
Identifier Type: -
Identifier Source: org_study_id