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

February 6, 2013 updated by: Adriana Ivonne Cervantes Vázquez., American British Cowdray Medical Center

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).

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mexico City, DF, Mexico, 05300
        • Recruiting
        • ABC Medical Center
        • Contact:
        • Principal Investigator:
          • Adriana Cervantes, MD
        • Sub-Investigator:
          • Eduardo Galvan, MD, MSc
        • Sub-Investigator:
          • Paul J Lamothe, MD
        • Sub-Investigator:
          • Roberto Rincón
        • Sub-Investigator:
          • Victor Pérez
        • Sub-Investigator:
          • Mabel Chiquillo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with spinal cord injury.

Description

Inclusion Criteria:

  • Spinal cord injury

Exclusion Criteria:

  • Patient with any other injury/lesion that produces dependence or disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SCIM scores for patients with SCI
All patients with SCI included in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Initial evaluation and 7 days after.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American British Cowdray Medical Center

Investigators

  • Principal Investigator: Adriana Ivonne Cervantes Vasquez, MD, Centro Médico ABC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

January 1, 2014

Study Registration Dates

First Submitted

February 1, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (ESTIMATE)

February 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABC-SCIM-01-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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