Study to Assess the Validity and Reliability of the Spinal Cord Independence Measure (SCIM III)
|First Submitted Date||December 12, 2007|
|First Posted Date||December 14, 2007|
|Last Update Posted Date||November 4, 2010|
|Start Date||September 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00573976 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Study to Assess the Validity and Reliability of the Spinal Cord Independence Measure (SCIM III)|
|Official Title||United States Multi-Center Study to Assess the Validity and Reliability of the Spinal Cord Independence Measure (SCIM III)|
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.
STUDY PURPOSE This clinical research study will be 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).
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.
Aim 2: Examine the reliability of SCIM III evaluations.
Aim 3: Examine the sensitivity of the SCIM III to functional change.
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.
|Study Design||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
The characteristics of the proposed subject population include:
|Condition||Spinal Cord Injury|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Completion Date||September 2010|
|Primary Completion Date||Not Provided|
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Not Provided|
|Removed Location Countries|
|Other Study ID Numbers||OCRT07019
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Kimberly D. Anderson, Ph.D, University of California, Irvine|
|Study Sponsor||University of California, Irvine|
|PRS Account||University of California, Irvine|
|Verification Date||November 2010|