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Reliability and Validity of the ISNCSCI in Patients With Non-traumatic Spinal Cord Lesions

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: NCT04949763
Recruitment Status : Completed
First Posted : July 2, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Giorgio Scivoletto, I.R.C.C.S. Fondazione Santa Lucia

Study Description
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Brief Summary:
Aim of the study is to assess the psychometric properties of the International Standards for Neurological Classification of Spinal Cord Injury in subjects with non traumatic lesions.

Condition or disease Intervention/treatment
Spinal Cord Injuries Other: rehabilitation

Detailed Description:
All patients with non-traumatic SCI consecutively admitted to three Italian SCI centers (IRCCS Fondazione Santa Lucia, Montecatone Rehabilitation Hospital and Istituti Clinici Scientifici Maugeri IRCCS of Pavia) between January 1st 2017 and June 30th 2020 have been prospectively enrolled in the study.
Study Design
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Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability and Validity of the International Standards for Neurological Classification of Spinal Cord Injury in Patients With Non-traumatic Spinal Cord Lesions
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: rehabilitation
    Patients underwent ususal rehabilitation treatment

Outcome Measures
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Primary Outcome Measures :
  1. Interanational Standards for Neurological Classification of Spinal Cord Injury [ Time Frame: 1 year ]
    standards to evaluate neurological status of subject with spinal cord injury


Secondary Outcome Measures :
  1. Spinal Cord Independence Maesure [ Time Frame: 1 year ]
    Outcome measure to evaluate the independence in daily life activities for subjects with spinal cord injury


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with non traumatic spinal cord lesions
Criteria

Inclusion Criteria:

  • having a non-traumatic SCI
  • acute / subacute phase
  • any level and severity (ASIA Impairment Scale) of injury
  • having a cognitive status that allows collaboration in the exam.

Exclusion Criteria:

  • presence of dementia or cognitive decline;
  • having a pathology of the peripheral nervous system that may affect the evaluation of ISNCSCI;
  • having a multiple sclerosis
Contacts and Locations
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No Contacts or Locations Provided
  Study Documents (Full-Text)

Documents provided by Giorgio Scivoletto, I.R.C.C.S. Fondazione Santa Lucia:
Study Protocol and Statistical Analysis Plan  [PDF] May 1, 2021

More Information
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Publications:

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Responsible Party: Giorgio Scivoletto, MD, PhD, I.R.C.C.S. Fondazione Santa Lucia
ClinicalTrials.gov Identifier: NCT04949763    
Other Study ID Numbers: CE/PROG.838 29-05-20
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymized data will be available upon reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giorgio Scivoletto, I.R.C.C.S. Fondazione Santa Lucia:
non traumatic spinal cord injury
ISNCSCI
inter-rater reliability
rehabilitation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System