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

This study has been completed.
Sponsor:
Collaborators:
University of Pittsburgh
University of Texas Southwestern Medical Center
Rancho Los Amigos National Rehabilitation Center
University of Missouri-Columbia
Long Beach VA Medical Center
Allina Hospitals and Clinics
University of Kentucky
Mayo Clinic
University of Louisville
Rehabilitation Institute of Chicago
Carolinas Healthcare System
Kessler Foundation
MedStar National Rehabilitation Network
MetroHealth Rehabilitation Institute of Ohio
Touro Rehabilitation Center
Mount Sinai School of Medicine
Medical College of Wisconsin
St. Joseph Hospital Health Center
Thomas Jefferson University
The Institute for Rehabilitation and Research
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00573976
First received: December 12, 2007
Last updated: November 2, 2010
Last verified: November 2010
  Purpose

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.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: United States Multi-Center Study to Assess the Validity and Reliability of the Spinal Cord Independence Measure (SCIM III)

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Estimated Enrollment: 660
Study Start Date: September 2007
Study Completion Date: September 2010
Detailed Description:

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.

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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
Criteria

Inclusion Criteria:

  • Any level SCI
  • 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:

  • Cognitive impairments
  • Any additional condition, other than SCI and SCI-related secondary conditions, that may influence everyday function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573976

Sponsors and Collaborators
University of California, Irvine
University of Pittsburgh
University of Texas Southwestern Medical Center
Rancho Los Amigos National Rehabilitation Center
University of Missouri-Columbia
Long Beach VA Medical Center
Allina Hospitals and Clinics
University of Kentucky
Mayo Clinic
University of Louisville
Rehabilitation Institute of Chicago
Carolinas Healthcare System
Kessler Foundation
MedStar National Rehabilitation Network
MetroHealth Rehabilitation Institute of Ohio
Touro Rehabilitation Center
Mount Sinai School of Medicine
Medical College of Wisconsin
St. Joseph Hospital Health Center
Thomas Jefferson University
The Institute for Rehabilitation and Research
Investigators
Principal Investigator: Kimberly D Anderson, Ph.D. University of California, Irvine
  More Information

No publications provided

Responsible Party: Kimberly D. Anderson, Ph.D, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573976     History of Changes
Other Study ID Numbers: OCRT07019, 2007-5854
Study First Received: December 12, 2007
Last Updated: November 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
SCIM
SCIM III
Multi-Center
United States

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

ClinicalTrials.gov processed this record on April 17, 2014