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

NCT ID: NCT04949763

Last Updated: 2021-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-01-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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rehabilitation

Patients underwent ususal rehabilitation treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S. Fondazione Santa Lucia

OTHER

Sponsor Role lead

Responsible Party

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Giorgio Scivoletto

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Rupp R, Biering-Sorensen F, Burns SP, Graves DE, Guest J, Jones L, Read MS, Rodriguez GM, Schuld C, Tansey-Md KE, Walden K, Kirshblum S. International Standards for Neurological Classification of Spinal Cord Injury: Revised 2019. Top Spinal Cord Inj Rehabil. 2021 Spring;27(2):1-22. doi: 10.46292/sci2702-1. No abstract available.

Reference Type BACKGROUND
PMID: 34108832 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CE/PROG.838 29-05-20

Identifier Type: -

Identifier Source: org_study_id

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