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

This study is currently recruiting participants.
Verified February 2013 by American British Cowdray Medical Center
Sponsor:
Information provided by (Responsible Party):
Adriana Ivonne Cervantes Vázquez., American British Cowdray Medical Center
ClinicalTrials.gov Identifier:
NCT01785277
First received: February 1, 2013
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Translation Into Spanish (Mexico) of the Spinal Cord Independence Measure III

Resource links provided by NLM:


Further study details as provided by American British Cowdray Medical Center:

Primary Outcome Measures:
  • Patient's change in independence measured by the translated SCIM-III version [ Time Frame: Initial evaluation and 7 days after. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
SCIM scores for patients with SCI
All patients with SCI included in the study

Detailed 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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with spinal cord injury.

Criteria

Inclusion Criteria:

  • Spinal cord injury

Exclusion Criteria:

  • Patient with any other injury/lesion that produces dependence or disability
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785277

Locations
Mexico
ABC Medical Center Recruiting
Mexico City, DF, Mexico, 05300
Contact: Adriana Cervantes, MD    55 52308000    adrivoncv@hotmail.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         
Sponsors and Collaborators
American British Cowdray Medical Center
Investigators
Principal Investigator: Adriana Ivonne Cervantes Vasquez, MD ABC Medical Center
  More Information

Publications:

Responsible Party: Adriana Ivonne Cervantes Vázquez., Chief of the Rehabilitation Department, American British Cowdray Medical Center
ClinicalTrials.gov Identifier: NCT01785277     History of Changes
Other Study ID Numbers: ABC-SCIM-01-2013
Study First Received: February 1, 2013
Last Updated: February 6, 2013
Health Authority: Mexico: National Council of Science and Technology

Keywords provided by American British Cowdray Medical Center:
Spinal Cord Independence Measure
SCIM
Spinal cord injury
Traumatic spine injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 17, 2014