Spinal Cord InjuriesNCT05421260
Paediatric Spinal Cord Injury and Long-term Social Outcomes.
An observational study of Spinal Cord Injuries, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult and paediatric onset SCI patients who have had their SCI for over 5 years.
Who may be able to join
- Age 18- 60 years
- SCI for over 5 years duration
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421260
- Sponsor's protocol ID
- RL1 815
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23098710Parent 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.
PubMed 21501096Vogel 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.
PubMed 9112971Vogel 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.
PubMed 9862289Kulshrestha 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.
PubMed 22270190Barclay 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.
PubMed 30156293Barclay 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.
PubMed 16955072
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Spinal Cord Injury and Long-term Social Outcomes.
- ClinicalTrials.gov ID
- NCT05421260
- Acronym / sponsor ID
- RL1 815
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult and paediatric onset SCI patients who have had their SCI for over 5 years.
Key inclusion criteria (2 listed)
- Age 18- 60 years
- SCI for over 5 years duration
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare long term quality of life between paediatric and adult-onset SCI patients.
Time frame: 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.
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.
To compare long term social activity and social participation between paediatric and adult-onset SCI patients.
Time frame: 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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Background: PubMed 23098710Vogel 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.
- Background: PubMed 21501096Parent 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.
- Background: PubMed 9112971Vogel 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.
- Background: PubMed 9862289Vogel 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.
- BackgroundKulshrestha 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.
- Background: PubMed 22270190Post 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.
- Background: PubMed 30156293Barclay 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.
- BackgroundBarclay 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
- Background: PubMed 16955072Biering-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Perkins (01691 404142, charlotteperkins1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare long term quality of life between paediatric and adult-onset SCI patients. (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05421260, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.