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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
Date last updated
2/12/2020

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
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.
Trial website
https://clinicaltrials.gov/study/NCT04117854
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04117854