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Long-Term Outcomes and Life Satisfaction of Adults With Pediatric-Onset Spinal Cord Injuries
This study is currently recruiting participants.
Verified by Shriners Hospitals for Children, April 2009
First Received: April 3, 2009   No Changes Posted
Sponsored by: Shriners Hospitals for Children
Information provided by: Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00876837
  Purpose

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.


Condition
Spinal Cord Injuries

MedlinePlus related topics: Spinal Cord Injuries
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Long-Term Outcomes and Life Satisfaction of Adults With Pediatric-Onset Spinal Cord Injuries

Further study details as provided by Shriners Hospitals for Children:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 411
Study Start Date: March 1998
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adults with pediatric-onset SCI

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.

  Eligibility

Ages Eligible for Study:   24 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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 24 years of age and older and who were injured at age 18 years or younger.

Criteria

Inclusion Criteria:

  • Individuals who are 24 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

Exclusion Criteria:

  • Non-english speaking individuals due to lack of measures in languages other than English and lack of foreign-speaking research assistants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876837

Contacts
Contact: Kathy Zebracki, Ph.D. 773-385-5832 kzebracki@shrinenet.org
Contact: Lawrence Vogel, M.D. 773-385-5528 lvogel@shrinenet.org

Locations
United States, Illinois
Shriners Hospitals for Children Recruiting
Chicago, Illinois, United States, 60707
Principal Investigator: Kathy Zebracki, Ph.D.            
Principal Investigator: Lawrence Vogel, M.D.            
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Kathy Zebracki, Ph.D. Shriners Hospitals for Children, Chicago
Principal Investigator: Lawrence Vogel, M.D. Shriners Hospitals for Children, Chicago
  More Information

Publications:
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.
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.
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.
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:S76-82.
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.
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.
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.
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.
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.
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.

Responsible Party: Shriners Hospitals for Children, Chicago ( Kathy Zebracki, Ph.D., Pediatric Psychologist )
Study ID Numbers: SHC-SCI-LT
Study First Received: April 3, 2009
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00876837     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on May 07, 2009