Spinal Cord InjuryNCT00573976
Study to Assess the Validity and Reliability of the Spinal Cord Independence Measure (SCIM III)
An observational study of Spinal Cord Injury, run by University of California, Irvine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 660 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Cognitive impairments
- Any additional condition, other than SCI and SCI-related secondary conditions, that may influence everyday function
About this study
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.
Read the 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.
- Criterion-related validity
- Construct validity of components
Aim 2: Examine the reliability of SCIM III evaluations.
- Inter-rater reliability
- Internal consistency
Aim 3: Examine the sensitivity of the SCIM III to functional change.
- Sensitivity to functional change compared to the Functional Independence Measure (FIM).
- 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.
- Conditions
- Spinal Cord Injury
- Keywords
- SCIM, SCIM III, Multi-Center, United States
- Medical subject headings
- Spinal Cord Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startSep 2007
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, University of Texas Southwestern Medical Center, Rancho Los Amigos National Rehabilitation Center, University of Missouri-Columbia, James A. Haley Veterans Administration Hospital, VA Long Beach Healthcare System, Allina Health System, University of Kentucky, Mayo Clinic, University of Louisville, Shirley Ryan AbilityLab, Wake Forest University Health Sciences, Kessler Foundation, MedStar National Rehabilitation Network, MetroHealth Rehabilitation Institute of Ohio, Touro Rehabilitation Center, Icahn School of Medicine at Mount Sinai, Medical College of Wisconsin, Unity Health Toronto, Thomas Jefferson University, The Institute for Rehabilitaion and Research Foundation
- Investigators
- Kimberly D Anderson, Ph.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573976
- Sponsor's protocol ID
- OCRT07019
- Other IDs
- 2007-5854
- Status last verified
- Nov 2010
- First submitted
- 12 Dec 2007
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- United States Multi-Center Study to Assess the Validity and Reliability of the Spinal Cord Independence Measure (SCIM III)
- ClinicalTrials.gov ID
- NCT00573976
- Acronym / sponsor ID
- OCRT07019
- Conditions
- Spinal Cord Injury
- Keywords
- SCIM, SCIM III, Multi-Center, United States
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of Pittsburgh, University of Texas Southwestern Medical Center, Rancho Los Amigos National Rehabilitation Center, University of Missouri-Columbia, James A. Haley Veterans Administration Hospital, VA Long Beach Healthcare System, Allina Health System, University of Kentucky, Mayo Clinic, University of Louisville, Shirley Ryan AbilityLab, Wake Forest University Health Sciences, Kessler Foundation, MedStar National Rehabilitation Network, MetroHealth Rehabilitation Institute of Ohio, Touro Rehabilitation Center, Icahn School of Medicine at Mount Sinai, Medical College of Wisconsin, Unity Health Toronto, Thomas Jefferson University, The Institute for Rehabilitaion and Research Foundation
- Study start
- Sep 2007
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- Criterion-related validity
- Construct validity of components
Aim 2: Examine the reliability of SCIM III evaluations.
- Inter-rater reliability
- Internal consistency
Aim 3: Examine the sensitivity of the SCIM III to functional change.
- Sensitivity to functional change compared to the Functional Independence Measure (FIM).
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive impairments
- Any additional condition, other than SCI and SCI-related secondary conditions, that may influence everyday function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly D Anderson, Ph.D. principal investigator
University of California, Irvine
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by University of California, Irvine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2010.