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Spinal Cord InjuriesNCT00876837

Long-term Outcomes and Life Satisfaction of Adults With Pediatric-Onset Spinal Cord Injuries

An observational study of Spinal Cord Injuries, run by Shriners Hospitals for Children at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess life satisfaction and long-term outcomes (i.e., medical and psychosocial) of adults who sustained spinal cord injuries (SCI) as children or adolescents. Read more about this study

Who is it for?
Ages 19 to 100 years
Conditions the study is for
Spinal Cord Injuries
How many people
514 participants
Where
1 siteUnited States
Study dates
Mar 1998to 25 Aug 2020
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 19 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The subjects for this study are adults who have received care in the SCI Programs of the Shriners Hospitals in Chicago, Philadelphia, or Northern California, who are 19 years of age and older and who were injured at age 18 years or younger.

Who may be able to join

  • Individuals who are 19 years of age and older
  • Were injured at the age of 18 years or younger
  • Received care at Shriners Hospitals for Children in Chicago, Philadelphia, or Northern California

Who cannot join

  • Non-English speaking individuals due to lack of measures in languages other than English and lack of foreign-speaking research assistants
  • severe brain injury

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Shriners Hospitals for Children

    Chicago, Illinois, 60707

Other trials in United States

About this study

The purpose of this study is to assess life satisfaction and long-term outcomes (i.e., medical and psychosocial) of adults who sustained spinal cord injuries (SCI) as children or adolescents.

Read the detailed description

The ultimate goal of rehabilitation for children and adolescents with spinal cord injuries (SCIs) is to assure that they can grow up to have as productive and satisfying lives as their peers. Understanding factors associated with these outcomes of our patients after they have become adults may help to identify interventions and rehabilitation strategies that will optimize long-term outcomes. Long-term studies of adults with pediatric-onset SCI are needed to identify important outcomes, including survival, participation, health status and health-related quality of life, and life-satisfaction. Further, these outcomes need to be compared to population norms. Predictive models of important outcomes will be developed using independent factors, including demographic, impairment, functional limitation, participation, and environmental and personal factors. In addition, the impact of age at injury, upper extremity reconstruction or functional electrical stimulation implants, and the Mitrofanoff procedure on adult outcomes will be assessed. The stability of selected outcomes in comparison to normative and census data will be determined and factors associated with changes in these outcomes will be assessed.

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 groups in NCT00876837
Study groupRoleWhat they receive
Adults with pediatric-onset SCINot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. medical complications

    Assessment of medical complications, including pressure ulcers, spasticity, UTIs, hospitalizations

    Measured: annually

Secondary outcomes (1)

  1. psychological outcomes

    assessment of current psychological functioning, including depression, anxiety, happiness, and life satisfaction

    Measured: annually

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2009 (estimated)
  2. Study startMar 1998
  3. Primary completion25 Aug 2020
  4. Study completion25 Aug 2020

Resources

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
514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00876837
Sponsor's protocol ID
SHC-SCI-LT
Status last verified
Aug 2020
First submitted
3 Apr 2009
Last updated
26 Aug 2020
Results posted
No
Data monitoring committee
No

Publications

  • Deane KC, Chlan KM, Vogel LC, Zebracki K. Use of Appraisals of DisAbility Primary and Secondary Scale-Short Form (ADAPSS-sf) in individuals with pediatric-onset spinal cord injury. Spinal Cord. 2020 Mar;58(3):290-297. doi: 10.1038/s41393-019-0375-0. Epub 2019 Nov 7.

    PubMed 31700146

  • Anderson CJ, Vogel LC, Betz RR, Willis KM. Overview of adult outcomes in pediatric-onset spinal cord injuries: implications for transition to adulthood. J Spinal Cord Med. 2004;27 Suppl 1:S98-106. doi: 10.1080/10790268.2004.11753545.

    PubMed 15503711

  • Chen Y, Anderson CJ, Vogel LC, Chlan KM, Betz RR, McDonald CM. Change in life satisfaction of adults with pediatric-onset spinal cord injury. Arch Phys Med Rehabil. 2008 Dec;89(12):2285-92. doi: 10.1016/j.apmr.2008.06.008.

    PubMed 19061740

  • Anderson CJ, Vogel LC, Chlan KM, Betz RR. Coping with spinal cord injury: strategies used by adults who sustained their injuries as children or adolescents. J Spinal Cord Med. 2008;31(3):290-6. doi: 10.1080/10790268.2008.11760725.

    PubMed 18795479

  • Anderson CJ, Vogel LC, Chlan KM, Betz RR, McDonald CM. Depression in adults who sustained spinal cord injuries as children or adolescents. J Spinal Cord Med. 2007;30 Suppl 1(Suppl 1):S76-82. doi: 10.1080/10790268.2007.11754609.

    PubMed 17874691

  • Anderson CJ, Vogel LC, Willis KM, Betz RR. Stability of transition to adulthood among individuals with pediatric-onset spinal cord injuries. J Spinal Cord Med. 2006;29(1):46-56. doi: 10.1080/10790268.2006.11753856.

    PubMed 16572565

  • Vogel LC, Krajci KA, Anderson CJ. Adults with pediatric-onset spinal cord injuries: part 3: impact of medical complications. J Spinal Cord Med. 2002 Winter;25(4):297-305. doi: 10.1080/10790268.2002.11753632.

    PubMed 12482173

  • Anderson CJ, Krajci KA, Vogel LC. Life satisfaction in adults with pediatric-onset spinal cord injuries. J Spinal Cord Med. 2002 Fall;25(3):184-90. doi: 10.1080/10790268.2002.11753620.

    PubMed 12214905

  • Vogel LC, Krajci KA, Anderson CJ. Adults with pediatric-onset spinal cord injury: part 2: musculoskeletal and neurological complications. J Spinal Cord Med. 2002 Summer;25(2):117-23. doi: 10.1080/10790268.2002.11753611.

    PubMed 12137215

  • Vogel LC, Krajci KA, Anderson CJ. Adults with pediatric-onset spinal cord injury: part 1: prevalence of medical complications. J Spinal Cord Med. 2002 Summer;25(2):106-16. doi: 10.1080/10790268.2002.11753610.

    PubMed 12137214

  • Anderson CJ, Vogel LC. Employment outcomes of adults who sustained spinal cord injuries as children or adolescents. Arch Phys Med Rehabil. 2002 Jun;83(6):791-801. doi: 10.1053/apmr.2002.32742.

    PubMed 12048657

  • Zebracki, K., Anderson, C., Chlan, K., & Vogel, L. (2010). Outcomes of adults with pediatric-onset spinal cord injury: Longitudinal findings and implications on transition to adulthood. Topics in Spinal Cord Injury Rehabilitation, 16(1), 17-25. Doi: 10.1310/sci1601-17

  • Vogel LC, Chlan KM, Zebracki K, Anderson CJ. Long-term outcomes of adults with pediatric-onset spinal cord injuries as a function of neurological impairment. J Spinal Cord Med. 2011;34(1):60-6. doi: 10.1179/107902610X12883422813787.

    PubMed 21528628

  • Chlan KM, Zebracki K, Vogel LC. Spirituality and life satisfaction in adults with pediatric-onset spinal cord injury. Spinal Cord. 2011 Mar;49(3):371-5. doi: 10.1038/sc.2010.80. Epub 2010 Jul 6.

    PubMed 20603633

  • Hwang M, Chlan KM, Vogel LC, Zebracki K. Substance use in young adults with pediatric-onset spinal cord injury. Spinal Cord. 2012 Jul;50(7):497-501. doi: 10.1038/sc.2012.8. Epub 2012 Feb 28.

    PubMed 22370762

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injuries, run by Shriners Hospitals for Children at 1 site in United States.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

medical complications (time frame: annually). 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 NCT00876837, which also lists 28 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 26 Aug 2020.

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