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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04117854




Registration number
NCT04117854
Ethics application status
Date submitted
12/06/2018
Date registered
7/10/2019

Titles & IDs
Public title
Spinal Cord Injury in the Pediatric Population - an International Multicenter Study
Scientific title
Sunnaas International Network Pediatric Spinal Cord Injury Study - an International Multicenterstudy in Seven Countries
Secondary ID [1] 0 0
SINpedSCI2018
Universal Trial Number (UTN)
Trial acronym
SINpedSCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric ALL 0 0
Spinal Cord Injuries 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Perception of psychosocial aspects
Timepoint [1] 0 0
October 2018 - June 2021
Primary outcome [2] 0 0
Organization and delivery of rehabilitation services
Timepoint [2] 0 0
October 2018 - December 2020
Secondary outcome [1] 0 0
Translation and cross-cultural adaptation of PEDI SCI in to Norwegian
Timepoint [1] 0 0
October 2020 - December 2022

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
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter New - Caulfield
Recruitment postcode(s) [1] 0 0
3162 - Caulfield
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
China
State/province [2] 0 0
Feng Tai District
Country [3] 0 0
China
State/province [3] 0 0
Sichuan
Country [4] 0 0
Israel
State/province [4] 0 0
Tel HaShomer
Country [5] 0 0
Norway
State/province [5] 0 0
Bjørnemyr
Country [6] 0 0
Palestinian Territory, occupied
State/province [6] 0 0
Bethlehem
Country [7] 0 0
Russian Federation
State/province [7] 0 0
Karelia
Country [8] 0 0
Sweden
State/province [8] 0 0
Gothenburg
Country [9] 0 0
Sweden
State/province [9] 0 0
Linköping
Country [10] 0 0
Sweden
State/province [10] 0 0
Solna

Funding & Sponsors
Primary sponsor type
Other
Name
Sunnaas Rehabilitation Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Oslo Metropolitan University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Oslo
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Karolinska Institutet
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johan K Stanghelle, Professor
Address 0 0
Sunnaas Rehabilitation Hospital, University of Oslo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wiebke Höfers, PhD student
Address 0 0
Country 0 0
Phone 0 0
+46 96869346
Fax 0 0
Email 0 0
wiehof@sunnaas.no
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04117854