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

• ClinicalTrials.gov Identifier: NCT04117854
• Recruitment Status: Recruiting
• First Posted: October 7, 2019
• Last Update Posted: December 2, 2020
• Sponsor: Sunnaas Rehabilitation Hospital
• Collaborators: Oslo Metropolitan University; University of Oslo; Karolinska Institutet
• Information provided by (Responsible Party): Kirsti Skavberg Roaldsen, Sunnaas Rehabilitation Hospital

Study Description

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

Detailed Description:

INTRODUCTION Spinal cord injury (SCI) before the age of 15 is rare affecting less than 1 in every 100 000 children. Over the past decade the management of pediatric spinal cord injury and the long-term outcomes have received increased attention, however, most research has its origin from the US. Thus, there is a need for more knowledge about occurrence and causes, functional recovery, activity, participation and quality of life in children and adolescents in other countries than the US. Moreover, a systematic review 2011 shows that there is limited evidence about the effectiveness of interventions for the management of children with SCI.

Knowledge regarding organization of care and rehabilitation is incomplete and differences between countries are substantial. Also, comparisons of data between countries and studies have been problematic due to differences in case definitions and age limits as to what is considered pediatric as opposed to adult SCI. Therefore, there is a need for international collaboration and research within the area of pediatric SCI with uniformity in methodology in the gathering of information and publication of the data to compare results between countries.

Due to the low incidence of pediatric SCI and the demand for more knowledge and research, international cooperation is needed for purposes of building a solid and common understanding of the scope of the problem and uniformity in management and methodology.

To reach this goal in the SIN context there is a need to benchmark between units, to highlight opportunities to improve systems of care and service delivery and to provide an understanding of the context of the units and the similarities and differences between them as this will be important for interpreting the results from subsequent phases of this project when patient outcomes are reported.

Exploration of psycho-social issues from the perspective of the affected young persons and their families will assist targeting issues that are clinically and socially relevant for future service and future research cooperation. In addition, to be able to gather information to compare results between countries it is important to establish use of common outcome measures.

AIMS AND OBJECTIVES Long term aim and objective The long-term goal of this research project is to optimize organization, care and rehabilitation in Norway and cooperating rehabilitation units internationally, to increase the awareness of subjective perceptions and psychosocial aspect of young persons with spinal cord injury, and to establish the use of outcome measures in local languages. Participants will be recruited from the rehabilitation hospitals cooperating within the Sunnaas International Network for Rehabilitation; Norway, Sweden, China, Russia, US, Israel, Palestine (SIN-units).

Specific aims and objectives

• To survey the SIN units in order to describe and compare the organization and delivery of inpatient rehabilitation services and systems of care for pediatric SCI patients
• To explore qualitatively psychosocial aspects of living with spinal cord injury in children and adolescents in SIN units using individual, semi-structured interviews

MATERIAL AND METHODS Study design This project is a cross sectional international multicenter study. A PhD-student is associated with the study (Oslo Metropolitan University/ Sunnaas Rehabilitation Hospital, start September 2019).

The first stage of the project (Phase I) will comprise a descriptive part (Study I, Web survey) and an explorative part (Study II, semi-structured interviews) conducted in clinical settings in Norway, Sweden, China, Russia, US, Israel and Palestine.

Recruitment The recruitment will be done within the units cooperating in the Sunnaas International Network for Rehabilitation (SIN).

The local principle investigator in each unit will be responsible for collecting data in Study I and recruiting individuals to participate in Study II of the study. Potentially eligible individuals with SCI will be identified from the departmental or institutional database. If no suitable database is present in an investigative site, recruitment through alternative databases will be explored and discussed with project collaborators.

Once identified, the study coordinator and local investigator will agree participant identification codes for the selected individuals. The study coordinator will allocate a three letter code (the first two letters will originate from the country of the study site, and the third from the name of the institution).

Inclusion criteria´s for the target group

• Children and adolescents (< 18 years)
• Diagnoses: either a non-traumatic or traumatic SCI after the age of 7
• Has been discharged from initial rehabilitation for 6 months or more

General 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)

Participants Study I (descriptive study/ web survey). Ten rehabilitation units in Norway, Sweden, China, Russia, US, Israel and Palestine will be participating. The local principle investigator in each unit will be responsible for data collection.

Study II (explorative study/semi-structured interviews). Two individuals in each of the ten SIN units, fulfilling the inclusion criteria's, will be recruited. A maximum of 20 young informants 13-17 years will be interviewed and constitute the study group of the International qualitative study. In addition, all norwegian youth with SCI rehabilitated at Sunnaas Rehabilitation Hospital fulfilling the inclusion criteria and beeing13-17 years of age during the inclusion period, will be recruited and constitute the study group of the Norwegian qualitative study (6-10 persons). Pilot interviews will be conducted prior to data collection.

Data collection and analyzing Study I (descriptive study/ web survey) A web-survey based on clinical expertise and literature review have been developed in cooperation between Dr Peter W New, Spinal Rehabilitation Service, Caulfield Hospital, Australia and Norwegian clinicians and researchers with experience in pediatric SCI. The survey is a development and an adapted version of the survey used to conduct an international comparison of the organization of rehabilitation services and systems of care for adult patients with non-traumatic SCI in Italy, Ireland, India, Pakistan, Switzerland, the Netherlands, US, Australia and Canada.

The survey will be used to gather descriptive data to review the various forms of care and rehabilitation services available to children and adolescents with SCI in SIN unit catchment areas. In addition, telephone or Skype-interviews will be used to complement data when necessary.

The following main issues will be explored (detailed questionnaire is available):

I. Hospital setting, interaction with acute hospitals and referral processes II. Rehabilitation beds and patient case-mix III. Spinal rehabilitation and staffing and therapy intensity IV. Availability of secondary staff, ancillary services and support V. Life long follow-up

Also, the following background information will be collected:

1. SCI-prevention programmes in the region
2. Brief review of the implementation of child protection in each region

The questionnaire will be available both electronically and in a paper version in English and will be completed by the local principal investigator (PI) or by a representative from each of the participating units chosen by the local PI. The local PI will be a bilingual person with good local knowledge. Clarification of responses will occur in cooperation between the local PI and the project manager at Sunnaas. Descriptive analysis will be performed with the median and interquartile range (IQR) reported for numerical data not normally distributed.

Study II (explorative study/ interviews) An inductive, exploratory study with a qualitative design will be chosen to obtain a detailed description and understanding of how children aged of 13-17 years, perceive living with SCI in SIN-unit catchment areas.

Individual, face-to-face interviews will be conducted based on a thematic, semi-structured interview guide with relevant follow-up questions. The interviews will take place in the informant's home or another place chosen by the informant. Ninety minutes or more will be allowed for each interview. Due to Corona restrictions virual interviews on a safe digital platform like Teams or Norske Helsenett will be allowed. This apply especially for the additional Norwegian interviews as they are planned to take place during the autumn of 2020 and spring of 2021.

A semi-structured interview guide has been developed in cooperation between researchers and clinicians with experience in working with children and adolescents. Appropriate open ended questions are listed within each main area of the interview and key-questions are marked to assure that they are asked for. A salutogenic approach with strength based questions built on established principles and guidelines for psychosocial screening in young persons has been used (EuTEACH; HEEADSSS assessment; HEADSSS assessment, Clinical Practice Guidelines).

Themes in the semi-structured interview guide (detailed interview guide is available):

• The injury/ the accident
• Acute care, rehabilitation and follow-up
• Daily living with SCI with a pediatric onset
• Home, education/employment, eating, activities, drugs, sexuality, suicide/depression/self-image, safety (HEEADSSS)
• Resources and networks
• Health
• Peer learning/ role models
• The future/ life goals

Pilot interviews will be conducted to test the interview guide before deciding on a final version that will be translated to all relevant languages.

To assure that all interviews are conducted in a good manner in different units, an educational curriculum will be developed. Also, the interviewers will be trained in a 2-day seminar. All interviews will be taped with a digital voice recorder and transcribed verbatim in each unit. The transcripts will be translated to Norwegian by bilingual translators with knowledge of neurological rehabilitation and analyzed using inductive qualitative content analysis seeking to identify both manifest categories and underlying, latent meanings.

ETHICAL CONSIDERATIONS Ethical approval will be applied for in each country (Norway, Sweden, China, Russia, US, Israel and Palestine). All encoded material will be entered in a database at the Department of Research, Sunnaas Rehabilitation Hospital. Passkey will be stored separately and locked in a fireproof safe. Recorded/taped interviews will be transcribed and encoded and both the audio file (also encoded) and the transcript will be stored in a locked, fireproof safe.

Candidate participants will be approached and informed about the study by a letter. The letter will explain (1) the purpose of the study, (2) the procedures and (3) confidentiality. The participant will be informed about their right to withdraw at any time and for any reason without affecting your treatment by any means. The letter will include an 'Informed Consent Form' that he/she and his/her caregivers must sign and date and return to their study site before they can participate.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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 ]
   PEDI SCI

Eligibility Criteria

• 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.

Criteria

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)

Contacts and Locations

Contacts

Contact: Wiebke Höfers, PhD student; +46 96869346; wiehof@sunnaas.no

Contact: Kirsti S Roaldsen, Professor; +46 708776790; kirsti.skavberg.roaldsen@ki.se

Locations

United States, New York

Rusk Institute of Rehabilitation Medicine; Recruiting

New York, New York, United States, 10016

Contact: Tamara Bushnik, PhD Tamara.bushnik@nyumc.org

Sub-Investigator: Renat Sukhov, MD

Sub-Investigator: Afua Asante, MD

Australia

Peter New; Not yet recruiting

Caulfield, Australia, 3162

Contact: Peter New, PhD MD p.new@alfred.org.au

China, Feng Tai District

China Rehabilitation and Research Center (CRRC); Recruiting

Beijing, Feng Tai District, China, 100068

Contact: Liu Genlin, MD Liugenlin2001@126.com

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 443839625@qq.com

Sub-Investigator: Qin Yu-Xi, MD

Israel

The Edmond & Lily Safra Children's Hospital, the Chaim Sheba Medical Center; Recruiting

Tel Aviv, Tel HaShomer, Israel, 52621

Contact: Dafna Guttman, MD Dafna.gutman@sheba.health.gov.il

Sub-Investigator: Tal Krasovsky, PhD PT

Norway

Björneveien 11; Recruiting

Oslo, Bjørnemyr, Norway, 1453

Contact: Wiebke Höfers, PhD student +46 708776790 wiehof@sunnaas.no

Contact: Kirsti S Roaldsen, Professor PT +46 708776790 kirsti.skavberg.roaldsen@ki.se

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 atheer@basr.org

Sub-Investigator: Eman Hamdan

Russian Federation

Policlinica 2 & Petrozavodsk City Children's Hospital; Recruiting

Petrozavodsk, Karelia, Russian Federation, 185003

Contact: Olga Zakharova, MD drzov@mail.ru

Sub-Investigator: Zinaida Trukhankana, MD

Sweden

Sahlgrenska University Hospital; Recruiting

Gothenburg, Sweden

Contact: Ann L Söderberg, RN Ann.l.soderberg@vgregion.se

Sub-Investigator: Katharina S Sunnerhagen, PhD MD

Linköping University Hospital; Recruiting

Linköping, Sweden

Contact: Per Ertzgaard, MD Per.ertzgaard@liu.se

Sub-Investigator: Marika Augutis, PhD PT

Rehab Station Stockholm/ Spinalis; Recruiting

Solna, Sweden, 16989

Contact: Kerstin Wahman, PhD kerstin.wahman@rehabstation.se

Sub-Investigator: Kerstin Wahman, PhD PT

Sponsors and Collaborators

Sunnaas Rehabilitation Hospital

Oslo Metropolitan University

University of Oslo

Karolinska Institutet

Investigators

• 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

More Information

• Responsible Party: Kirsti Skavberg Roaldsen, Professor, Sunnaas Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT04117854
• Other Study ID Numbers: SINpedSCI2018
• First Posted: October 7, 2019
• Last Update Posted: December 2, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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; pediatric; qualitative interviews; web survey; international; multicenter; traumatic SCI; atraumatic SCI

Additional relevant MeSH terms:

Spinal Cord Injuries; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System