Spinal Cord Injury Clinical Trial
Official title:
Validation of a Translation Into Spanish (Mexico) of the Spinal Cord Independence Measure III
The propose of the study is to validate in Mexico a spanish translation of the Spinal Cord
Independence Measure (SCIM) Version III, in patients with spinal cord injury (SCI).
Internal consistency, reproducibility and reliability will be addressed scoring the results
of the translated version at two time frames and also of the same patients by different
examiners (physicians, nurses and technicians).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: - Spinal cord injury Exclusion Criteria: - Patient with any other injury/lesion that produces dependence or disability |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Mexico | ABC Medical Center | Mexico City | DF |
Lead Sponsor | Collaborator |
---|---|
American British Cowdray Medical Center |
Mexico,
Bluvshtein V, Front L, Itzkovich M, Aidinoff E, Gelernter I, Hart J, Biering-Soerensen F, Weeks C, Laramee MT, Craven C, Hitzig SL, Glaser E, Zeilig G, Aito S, Scivoletto G, Mecci M, Chadwick RJ, El Masry WS, Osman A, Glass CA, Silva P, Soni BM, Gardner BP, Savic G, Bergström EM, Catz A. SCIM III is reliable and valid in a separate analysis for traumatic spinal cord lesions. Spinal Cord. 2011 Feb;49(2):292-6. doi: 10.1038/sc.2010.111. Epub 2010 Sep 7. — View Citation
Catz A, Itzkovich M, Agranov E, Ring H, Tamir A. SCIM--spinal cord independence measure: a new disability scale for patients with spinal cord lesions. Spinal Cord. 1997 Dec;35(12):850-6. — View Citation
Catz A, Itzkovich M, Agranov E, Ring H, Tamir A. The spinal cord independence measure (SCIM): sensitivity to functional changes in subgroups of spinal cord lesion patients. Spinal Cord. 2001 Feb;39(2):97-100. — View Citation
Cripps RA, Lee BB, Wing P, Weerts E, Mackay J, Brown D. A global map for traumatic spinal cord injury epidemiology: towards a living data repository for injury prevention. Spinal Cord. 2011 Apr;49(4):493-501. doi: 10.1038/sc.2010.146. Epub 2010 Nov 23. Review. — View Citation
Ho CH, Wuermser LA, Priebe MM, Chiodo AE, Scelza WM, Kirshblum SC. Spinal cord injury medicine. 1. Epidemiology and classification. Arch Phys Med Rehabil. 2007 Mar;88(3 Suppl 1):S49-54. Review. — View Citation
Kirshblum SC, Priebe MM, Ho CH, Scelza WM, Chiodo AE, Wuermser LA. Spinal cord injury medicine. 3. Rehabilitation phase after acute spinal cord injury. Arch Phys Med Rehabil. 2007 Mar;88(3 Suppl 1):S62-70. Review. — View Citation
Wyndaele M, Wyndaele JJ. Incidence, prevalence and epidemiology of spinal cord injury: what learns a worldwide literature survey? Spinal Cord. 2006 Sep;44(9):523-9. Epub 2006 Jan 3. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's change in independence measured by the translated SCIM-III version | The objective of this outcome is to evaluate the ability of the translated SCIM-III version to asses the patients grade of independence in two different time frames and by two different examiners. | Initial evaluation and 7 days after. | No |
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