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

Spinal Cord Injuries Clinical Trial

Official title:

Reliability and Validity of the International Standards for Neurological Classification of Spinal Cord Injury in Patients With Non-traumatic Spinal Cord Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949763
• Other study ID #: CE/PROG.838 29-05-20
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 15, 2021

Study information

• Verified date: June 2021
• Source: I.R.C.C.S. Fondazione Santa Lucia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 15, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Other:
• rehabilitation
Patients underwent ususal rehabilitation treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
I.R.C.C.S. Fondazione Santa Lucia

References & Publications (1)

Rupp R, Biering-Sørensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interanational Standards for Neurological Classification of Spinal Cord Injury	standards to evaluate neurological status of subject with spinal cord injury	1 year
Secondary	Spinal Cord Independence Maesure	Outcome measure to evaluate the independence in daily life activities for subjects with spinal cord injury	1 year