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

NCT00573976 | Completed

• 2 other identifiers: OCRT070192007-5854
• Study Type: observational
• Target: 660
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

SCIM; SCIM III; Multi-Center; United States

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairments
• Any additional condition, other than SCI and SCI-related secondary conditions, that may influence everyday function

Sponsors & Collaborators

• University of California, Irvine: lead
• University of Pittsburgh: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Rancho Los Amigos National Rehabilitation Center: collaborator
• University of Missouri-Columbia: collaborator
• James A. Haley Veterans Administration Hospital: collaborator
• VA Long Beach Healthcare System: collaborator
• Allina Health System: collaborator
• University of Kentucky: collaborator
• Mayo Clinic: collaborator
• University of Louisville: collaborator
• Shirley Ryan AbilityLab: collaborator
• Wake Forest University Health Sciences: collaborator
• Kessler Foundation: collaborator
• MedStar National Rehabilitation Network: collaborator
• MetroHealth Rehabilitation Institute of Ohio: collaborator
• Touro Rehabilitation Center: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Medical College of Wisconsin: collaborator
• Unity Health Toronto: collaborator
• Thomas Jefferson University: collaborator
• The Institute for Rehabilitaion and Research Foundation: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kimberly D Anderson, Ph.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: September 1, 2007
• Study Completion: September 1, 2010
• Last Updated: November 4, 2010

Record last verified: 2010-11