Study to Assess the Validity and Reliability of the Spinal Cord Independence Measure (SCIM III)

Summary

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.

Conditions

• Spinal Cord Injury

Sponsors & Collaborators

• University of Pittsburgh

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Rancho Los Amigos National Rehabilitation Center

  collaborator OTHER

• University of Missouri-Columbia

  collaborator OTHER

• James A. Haley Veterans Administration Hospital

  collaborator FED

• VA Long Beach Healthcare System

  collaborator FED

• Allina Health System

  collaborator OTHER

• University of Kentucky

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Louisville

  collaborator OTHER

• Shirley Ryan AbilityLab

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Kessler Foundation

  collaborator OTHER

• MedStar National Rehabilitation Network

  collaborator OTHER

• MetroHealth Rehabilitation Institute of Ohio

  collaborator UNKNOWN

• Touro Rehabilitation Center

  collaborator UNKNOWN

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• The Institute for Rehabilitaion and Research Foundation

  collaborator OTHER

• University of California, Irvine

  lead OTHER

Principal Investigators

• Kimberly D Anderson, Ph.D. · University of California, Irvine

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-09-30

Completion

2010-09-30