Paediatric Spinal Cord Injury and Long-term Social Outcomes.

To provide the overall quality of life (QOL), activity and participation values for adults with paediatric onset spinal cord injury (SCI), stratified by injury level, neurological status and compare it with matched controls with adults with adult-onset SCI.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries

Detailed Description

Evidence obtained from adult studies demonstrate that SCI can be a devastating experience that may result in reduced independence and change one's ability to participate in meaningful roles and activities.

Sadly, there is a paucity of similar studies into paediatric onset SCI. The profile of paediatric patients with SCI is different from adults and their long-term wellbeing outcomes are not well researched. Maximizing activity and participation following SCI is an important aspect of rehabilitation. Community integration is a long process that might take months to years after discharge from hospital after the initial injury. After discharge from hospital the subsequent management is done by community team comprising of physio and occupational therapists who are pivotal in supporting re-engagement in social activities.

There is a need for thorough analysis regarding the social outcomes of adults living with paediatric onset SCI. Quality of life, or life satisfaction, is arguably the most important outcome for children and adolescents with SCIs. This outcome may be the key to assessing the success of our treatment pathways and will allow us to target the resources available for rehabilitation to maximize the effects of rehabilitation programs.

There are large gaps in the literature regarding paediatric SCIs. Clinicians often struggle to give informed answers to questions such as:

• Will a child with SCI experience good quality of life in adulthood?
• Is there a difference in social activity and participation between adult onset and paediatric onset injuries?
• What helps social activity and participation of SCI patients?
• Is tetraplegia worse than paraplegia for social participation?
• Does social participation affect quality of life?
• Where can we target resources in rehabilitation program?

This study aspires to address these questions by conducting this questionnaire study to understand the factors that affect social participation. This will enable to highlight areas to target future resources for rehabilitation programmes.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Charlotte Perkins; Phone Number: 01691 404142; Email: charlotteperkins1@nhs.net
• Study Contact Backup: Name: Julie Steen, BSc (Hons); Phone Number: 01691 404210; Email: julie.steen@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult and paediatric onset SCI patients who have had their SCI for over 5 years.

Description

Inclusion Criteria:

• Age 18- 60 years
• SCI for over 5 years duration

Exclusion Criteria:

• Patients unable to speak and understand English
• Patients not able to speak on phone
• Patients with intellectual disability affecting their ability to speak without aids.
• Cauda equina syndrome

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Adult onset SCI; Spinal cord injury accident when the patient is over the age of 18 years old.
Paediatric onset SCI; Spinal cord injury accident when the patient is under the age of 18 years old.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare long term quality of life between paediatric and adult-onset SCI patients.	By interviewing the participant, using a validated questionnaire from the International SCI data set, the Quality of Life basic data set, version 1.0, the long term quality of life can be assessed.	This interview (a combination of these validated questionnaires) will take place within 30 days of seeking consent from the participant. Once the interview has taken place, the participant has completed the research study.
To compare long term social activity and social participation between paediatric and adult-onset SCI patients.	By interviewing the participant, using a validated questionnaire from the International SCI data set, Activities and participation basic data set, Version 1.0, August 2012, the social activity and social participation can be assessed.	This interview (a combination of these validated questionnaires) will take place within 30 days of seeking consent from the participant. Once the interview has taken place, the participant has completed the research study.

Collaborators and Investigators

• Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Publications and helpful links

General Publications

• Vogel LC, Betz RR, Mulcahey MJ. Spinal cord injuries in children and adolescents. Handb Clin Neurol. 2012;109:131-48. doi: 10.1016/B978-0-444-52137-8.00008-5.
• Parent S, Mac-Thiong JM, Roy-Beaudry M, Sosa JF, Labelle H. Spinal cord injury in the pediatric population: a systematic review of the literature. J Neurotrauma. 2011 Aug;28(8):1515-24. doi: 10.1089/neu.2009.1153. Epub 2011 Jun 9.
• Vogel L, Mulcahy MJ, Betz RR. The child with a spinal cord injury. Dev Med Child Neurol. 1997 Mar;39(3):202-7. doi: 10.1111/j.1469-8749.1997.tb07411.x. No abstract available.
• Vogel LC, Klaas SJ, Lubicky JP, Anderson CJ. Long-term outcomes and life satisfaction of adults who had pediatric spinal cord injuries. Arch Phys Med Rehabil. 1998 Dec;79(12):1496-503. doi: 10.1016/s0003-9993(98)90409-9.
• Kulshrestha R, Kumar N, Chowdhury JR, Osman A, El Masri W. Long-term outcome of paediatric spinal cord injury. Trauma, 2017, 19,1_suppl: 75-82.
• Post MW, van Leeuwen CM. Psychosocial issues in spinal cord injury: a review. Spinal Cord. 2012 May;50(5):382-9. doi: 10.1038/sc.2011.182. Epub 2012 Jan 24.
• Barclay L, Lentin P, Bourke-Taylor H, McDonald R. The experiences of social and community participation of people with non-traumatic spinal cord injury. Aust Occup Ther J. 2019 Feb;66(1):61-67. doi: 10.1111/1440-1630.12522. Epub 2018 Aug 29.
• Barclay L, Callaway L, McDonald R, Farnworth L, Brown T, Broom L. Time Use following Spinal Cord Injury: An Examination of the Literature. British Journal of Occupational Therapy. 2011; 74 (12): 573-580
• Biering-Sorensen F, Charlifue S, DeVivo M, Noonan V, Post M, Stripling T, Wing P. International Spinal Cord Injury Data Sets. Spinal Cord. 2006 Sep;44(9):530-4. doi: 10.1038/sj.sc.3101930.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (ACTUAL): June 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: RL1 815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No