NCT01785277

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

February 1, 2013

Last Update Submit

February 6, 2013

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Independence MeasureSCIMSpinal cord injuryTraumatic spine injury

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

SCIM scores for patients with SCI

All patients with SCI included in the study

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with spinal cord injury.

You may qualify if:

  • Spinal cord injury

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ABC Medical Center

Mexico City, Mexico City, 05300, Mexico

RECRUITING

Related Publications (7)

  • 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.

    PMID: 21102572BACKGROUND

  • 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. doi: 10.1016/j.apmr.2006.12.001.

    PMID: 17321849BACKGROUND

  • 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. doi: 10.1038/sj.sc.3101893. Epub 2006 Jan 3.

    PMID: 16389270BACKGROUND

  • 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. doi: 10.1016/j.apmr.2006.12.003.

    PMID: 17321851BACKGROUND

  • 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. doi: 10.1038/sj.sc.3101118.

    PMID: 11402366BACKGROUND

  • 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. doi: 10.1038/sj.sc.3100504.

    PMID: 9429264BACKGROUND

  • 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, Bergstrom 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.

    PMID: 20820178BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Adriana Ivonne Cervantes Vasquez, MD

    Centro Medico ABC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Rehabilitation Department

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 7, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

ME(1)