NCT04949763

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

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, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

3.5 years

First QC Date

June 22, 2021

Last Update Submit

June 30, 2021

Conditions

Spinal Cord Injuries

Keywords

non traumatic spinal cord injuryISNCSCIinter-rater reliabilityrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Interanational Standards for Neurological Classification of Spinal Cord Injury

    standards to evaluate neurological status of subject with spinal cord injury

    1 year

Secondary Outcomes (1)

  • Spinal Cord Independence Maesure

    1 year

Interventions

rehabilitationOTHER

Patients underwent ususal rehabilitation treatment

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with non traumatic spinal cord lesions

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34108832BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 22, 2021

First Posted

July 2, 2021

Study Start

January 1, 2017

Primary Completion

June 30, 2020

Study Completion

January 15, 2021

Last Updated

July 2, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Anonymized data will be available upon reasonable request