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United States Multi-Center Study to Assess the Validity and Reliability of the Spinal Cord Independence Measure (SCIM III)
Sponsor study identifier
Secondary identifiers
observational
660
0 countries
N/A
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2010
Actual (reported)In the past two decades there have been great strides made in understanding the biological changes resulting from spinal cord injury (SCI). The future holds promise of the development of therapies that will promote degrees of repair and recovery of function for people living with SCI. Lessons learned from past "failed" SCI clinical trials, however, demonstrate that, in order to accurately evaluate the overall effectiveness of SCI therapies, more sensitive outcomes measures are needed. Specifically, and reflecting the ultimate goal of clinical interventions - inducing functional recovery - the Spinal Cord Independence Measure (SCIM), has been recommended for further testing and development for use as a measure of functional ability in future SCI clinical studies. The SCIM is a very simple questionnaire and score sheet that an evaluator uses to determine how independently a person with SCI can perform certain tasks. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 12, 2007
Actual (reported)December 14, 2007
Actual (reported)September 2010
Actual (reported)The characteristics of the proposed subject population include: * Males and females 18 years of age or older * Adults who are competent to give informed consent * Subjects who are able to read or speak English
Kimberly D Anderson, Ph.D.
University of California, Irvine
First Submitted
December 12, 2007
First Posted
December 14, 2007
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
September 2010
Actual (reported)Contact the study team to confirm eligibility.
Last Updated
November 4, 2010
Record last verified: 2010-11
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Source: ClinicalTrials.gov.
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