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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04117854
Registration number
NCT04117854
Ethics application status
Date submitted
12/06/2018
Date registered
7/10/2019
Date last updated
2/12/2020
Titles & IDs
Public title
Spinal Cord Injury in the Pediatric Population - an International Multicenter Study
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Scientific title
Sunnaas International Network Pediatric Spinal Cord Injury Study - an International Multicenterstudy in Seven Countries
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Secondary ID [1]
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SINpedSCI2018
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Universal Trial Number (UTN)
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Trial acronym
SINpedSCI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pediatric ALL
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Spinal Cord Injuries
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Injuries and Accidents
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Other injuries and accidents
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Neurological
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Other neurological disorders
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Perception of psychosocial aspects
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Assessment method [1]
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Qualitative individual indepth interviews
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Timepoint [1]
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October 2018 - June 2021
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Primary outcome [2]
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Organization and delivery of rehabilitation services
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Assessment method [2]
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Web survey
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Timepoint [2]
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October 2018 - December 2020
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Secondary outcome [1]
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Translation and cross-cultural adaptation of PEDI SCI in to Norwegian
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Assessment method [1]
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PEDI SCI
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Timepoint [1]
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October 2020 - December 2022
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Eligibility
Key inclusion criteria
- Children and adolescents (< 18 years)
- Diagnoses: either a non-traumatic or traumatic SCI after the age of 7
- Has been discharged from acute treatment phase for 6 months or more
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Minimum age
13
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Diagnosis of severe neurological conditions affecting the cognition of the child or
adolescent (e.g. as a result of encephalocele or acquired brain injury)
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peter New - Caulfield
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Recruitment postcode(s) [1]
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3162 - Caulfield
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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China
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State/province [2]
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Feng Tai District
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Country [3]
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China
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State/province [3]
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Sichuan
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Country [4]
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Israel
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State/province [4]
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Tel HaShomer
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Country [5]
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Norway
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State/province [5]
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Bjørnemyr
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Country [6]
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Palestinian Territory, occupied
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State/province [6]
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Bethlehem
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Country [7]
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Russian Federation
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State/province [7]
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Karelia
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Country [8]
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Sweden
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State/province [8]
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Gothenburg
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Country [9]
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Sweden
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State/province [9]
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Linköping
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Country [10]
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Sweden
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State/province [10]
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Solna
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Funding & Sponsors
Primary sponsor type
Other
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Name
Sunnaas Rehabilitation Hospital
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Oslo Metropolitan University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Oslo
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Karolinska Institutet
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
INTRODUCTION: Due to the low incidence of pediatric spinal cord injury (SCI) and the high
demand for knowledge and research, international cooperation is needed to build a solid and
shared understanding of the extent of the problem, and also uniformity in treatment and
measurement methods. The aim of the study is to map organization of care and rehabilitation
of children and adolescents < 18 years of age with SCI, to explore qualitatively psychosocial
aspects of individuals and to establish use of common outcome measures in 10 rehabilitation
units from seven countries, cooperating within the Sunnaas International Network in
Rehabilitation (SIN); China, USA, Russia, Israel, Palestine, Norway and Sweden.
METHOD: In Phase I two cross-sectional studies will be conducted to set the scene for the
outcome studies following in Phase II (2020-2022). Phase I consists of a quantitative
descriptive study using a websurvey to describe and compare the systems of care and delivery
of inpatient rehabilitation services for pediatric SCI patients. In addition, a qualitative
study will explore the psychosocial aspects of living with a childhood acquired SCI. Two
adolescents, aged 13-17 years and at least 6 months post-acute treatment, from each unit will
interviewed using a semi-structured interview guide. Ethical approval has been applied for in
each unit, and the study is registered at ClinicalTrial-gov. A workshop for the 24 study team
members, where the main focus was to ensure that data collection is conducted in a good
manner, was held in May 2018, and data collection is expected finalized by 2020. Phase II
(planning stage) will consist of methodological outcome studies.
DISCUSSION: Phase I of the study will broaden the body of knowledge on pediatric SCI
internationally, thus enabling comparison, discussion and development of organizational
models and quality of care and rehabilitation for young persons with SCI. Phase II will
contribute to the use of common and reliable outcome measures for these patients.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04117854
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Johan K Stanghelle, Professor
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Address
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Sunnaas Rehabilitation Hospital, University of Oslo
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Wiebke Höfers, PhD student
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Address
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Country
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Phone
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+46 96869346
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04117854
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