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

NCT04117854 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-12-02

No results posted yet for this study

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.

Conditions

  • Pediatric ALL
  • Spinal Cord Injuries

Sponsors & Collaborators

  • Oslo Metropolitan University

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Sunnaas Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Johan K Stanghelle, Professor · Sunnaas Rehabilitation Hospital, University of Oslo

  • Kirsti S Roaldsen, Professor · Sunnaas Rehab Hospital, Karolinska Institutet and Oslo Met

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2022-12-31
Completion
2024-12-31

Countries

  • United States
  • Australia
  • China
  • Israel
  • Norway
  • Palestinian Territories
  • Russia
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04117854 on ClinicalTrials.gov