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Spinal Cord Injury in the Pediatric Population - an International Multicenter Study (SINpedSCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04117854
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : December 2, 2020
Oslo Metropolitan University
University of Oslo
Karolinska Institutet
Information provided by (Responsible Party):
Kirsti Skavberg Roaldsen, Sunnaas Rehabilitation Hospital

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.

Condition or disease
Pediatric ALL Spinal Cord Injuries

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Sunnaas International Network Pediatric Spinal Cord Injury Study - an International Multicenterstudy in Seven Countries
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Primary Outcome Measures :
  1. Perception of psychosocial aspects [ Time Frame: October 2018 - June 2021 ]
    Qualitative individual indepth interviews

  2. Organization and delivery of rehabilitation services [ Time Frame: October 2018 - December 2020 ]
    Web survey

Secondary Outcome Measures :
  1. Translation and cross-cultural adaptation of PEDI SCI in to Norwegian [ Time Frame: October 2020 - December 2022 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents between the age of 13-17 years of age diagnosed with a non-traumatic or a traumatic SCI after the age 7.

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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04117854

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Contact: Wiebke Höfers, PhD student +46 96869346
Contact: Kirsti S Roaldsen, Professor +46 708776790

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United States, New York
Rusk Institute of Rehabilitation Medicine Recruiting
New York, New York, United States, 10016
Contact: Tamara Bushnik, PhD   
Sub-Investigator: Renat Sukhov, MD         
Sub-Investigator: Afua Asante, MD         
Peter New Not yet recruiting
Caulfield, Australia, 3162
Contact: Peter New, PhD MD   
China, Feng Tai District
China Rehabilitation and Research Center (CRRC) Recruiting
Beijing, Feng Tai District, China, 100068
Contact: Liu Genlin, MD   
Sub-Investigator: Qi Zhang, MSc PT         
Sub-Investigator: Gao Feng, MD         
China, Sichuan
No 81 Rehabilitation Center Recruiting
Chengdu, Sichuan, China, 611135
Contact: Chen Yang, MD   
Sub-Investigator: Qin Yu-Xi, MD         
The Edmond & Lily Safra Children's Hospital, the Chaim Sheba Medical Center Recruiting
Tel Aviv, Tel HaShomer, Israel, 52621
Contact: Dafna Guttman, MD   
Sub-Investigator: Tal Krasovsky, PhD PT         
Björneveien 11 Recruiting
Oslo, Bjørnemyr, Norway, 1453
Contact: Wiebke Höfers, PhD student    +46 708776790   
Contact: Kirsti S Roaldsen, Professor PT    +46 708776790   
Sub-Investigator: Kristine Marie Vege, MD         
Sub-Investigator: Vivien Jørgensen, PhD PT         
Sub-Investigator: Wiebke Höfers, PhD student         
Principal Investigator: Kirsti S Roaldsen, Professor PT         
Sub-Investigator: Kristine E Sørland, RN         
Sub-Investigator: Johan K Stanghelle, Professor MD         
Palestinian Territory, occupied
Bethlehem Arab Society of Specialized Rehabilitation and Surgery Hospital Recruiting
Bethlehem, Palestinian Territory, occupied, 100
Contact: Atheer A Ghatasheh, MD   
Sub-Investigator: Eman Hamdan         
Russian Federation
Policlinica 2 & Petrozavodsk City Children's Hospital Recruiting
Petrozavodsk, Karelia, Russian Federation, 185003
Contact: Olga Zakharova, MD   
Sub-Investigator: Zinaida Trukhankana, MD         
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Ann L Söderberg, RN   
Sub-Investigator: Katharina S Sunnerhagen, PhD MD         
Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Per Ertzgaard, MD   
Sub-Investigator: Marika Augutis, PhD PT         
Rehab Station Stockholm/ Spinalis Recruiting
Solna, Sweden, 16989
Contact: Kerstin Wahman, PhD   
Sub-Investigator: Kerstin Wahman, PhD PT         
Sponsors and Collaborators
Sunnaas Rehabilitation Hospital
Oslo Metropolitan University
University of Oslo
Karolinska Institutet
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Study Director: Johan K Stanghelle, Professor Sunnaas Rehabilitation Hospital, University of Oslo
Principal Investigator: Kirsti S Roaldsen, Professor Sunnaas Rehab Hospital, Karolinska Institutet and Oslo Met
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Responsible Party: Kirsti Skavberg Roaldsen, Professor, Sunnaas Rehabilitation Hospital Identifier: NCT04117854    
Other Study ID Numbers: SINpedSCI2018
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirsti Skavberg Roaldsen, Sunnaas Rehabilitation Hospital:
spinal cord injury
qualitative interviews
web survey
traumatic SCI
atraumatic SCI
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System