Validation of a Translation Into Spanish (Mexico) of the Spinal Cord Independence Measure III

Spinal Cord Injury Clinical Trial

Official title:

Validation of a Translation Into Spanish (Mexico) of the Spinal Cord Independence Measure III

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01785277
• Other study ID #: ABC-SCIM-01-2013
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2013
• Last updated: February 6, 2013
• Start date: January 2013

Study information

• Verified date: February 2013
• Source: American British Cowdray Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Council of Science and Technology
• Study type: Observational

Clinical Trial Summary

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).

Description:

The worldwide estimated annual incidence of SCI has a broad spectrum, ranging from 236 to 1009 cases per million of people. In Mexico there is an estimate of 18.1 cases per million people, affecting primary men in their productive age (25-34 years old).

Most of the patients have disabilities after the injury, and become dependent of their families or professional care providers. The cornerstone treatment in the long therm is rehabilitation and the main goal is to achieve patient independence.

Over the last two decades many disability measure instruments have been developed, like the Functional Interdisciplinary Measure (FIM). This scale though it is very useful for patients' general outcome, it does not grade patients' independence entirely. In 1997, Dr. Amiram Catz developed the first version of the Spinal Cord Independence Measure (SCIM). Since its first version, it showed to be a very powerful tool to assess patients' independence. Recently, the SCIM-III has been validated in a multicenter study, showing validity, reliability and internal consistency.

The aim of this study is to perform a translate and trans-cultural adaptation of the SCIM-III into Spanish and to perform also its validation in Mexican population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
Mexico	ABC Medical Center	Mexico City	DF

Sponsors (1)

Lead Sponsor	Collaborator
American British Cowdray Medical Center

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

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

Outcome

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