Validation of a Translation Into Spanish (Mexico) of the Spinal Cord Independence Measure III
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01785277|
Recruitment Status : Unknown
Verified February 2013 by Adriana Ivonne Cervantes Vázquez., American British Cowdray Medical Center.
Recruitment status was: Recruiting
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
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).
|Condition or disease|
|Spinal Cord Injury|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Validation of a Translation Into Spanish (Mexico) of the Spinal Cord Independence Measure III|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2014|
SCIM scores for patients with SCI
All patients with SCI included in the study
- Patient's change in independence measured by the translated SCIM-III version [ Time Frame: Initial evaluation and 7 days after. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785277
|ABC Medical Center||Recruiting|
|Mexico City, DF, Mexico, 05300|
|Contact: Adriana Cervantes, MD 55 52308000 email@example.com|
|Principal Investigator: Adriana Cervantes, MD|
|Sub-Investigator: Eduardo Galvan, MD, MSc|
|Sub-Investigator: Paul J Lamothe, MD|
|Sub-Investigator: Roberto De Leo, MD|
|Sub-Investigator: Roberto Rincón|
|Sub-Investigator: Victor Pérez|
|Sub-Investigator: Mabel Chiquillo|
|Principal Investigator:||Adriana Ivonne Cervantes Vasquez, MD||ABC Medical Center|