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Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy

This study has been completed.
Sponsor:
Collaborators:
Kent State University
University of North Carolina
Alfred I. duPont Hospital for Children
Information provided by:
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT01019122
First received: November 20, 2009
Last updated: March 8, 2011
Last verified: March 2011
History of Changes
  Purpose

In 2003, observational growth and bone density data was obtained on children with cerebral palsy (CP) living at Hattie Larlham as part of a study comparing growth with an existing database of children with CP who live at home. The original residents included in that study are now of adult age. Due to the lack of longitudinal bone density measurements in facility-based adults with severe CP, the investigators' objective is to obtain 6-year follow-up data from the residents enrolled in the original study.


Condition Intervention
Cerebral Palsy
Bone Density
 Radiation: Dexa Scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Assessment of Bone Growth and Development in a Facility-Based Population of Children With Cerebral Palsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • Dual Energy X-ray Absorptiometry (DEXA) scan results [ Time Frame: 6 years from original DEXA scan ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dexa Scan
Eligible patients from 2003 study will receive a follow-up Dexa scan.
 Radiation: Dexa Scan
Dexa scan of left and right distal femur, then lumbar spine, and whole body when possible

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Residents of a long-term care facility for children with disabilities who have severe to profound CP and are non-ambulatory.

Criteria

Inclusion Criteria:

  • Resident of Hattie Larlham Center for Children with Disabilities (HLCCD)
  • Previously enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study in 2003

Exclusion Criteria:

  • Resident of HLCCD who was not enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019122

Sponsors and Collaborators
Akron Children's Hospital
Kent State University
University of North Carolina
Alfred I. duPont Hospital for Children
Investigators
Study Chair: Martha Blackford, PharmD Akron Children's Hospital
Study Chair: Michael Reed, PharmD Akron Children's Hospital
Study Chair: Richard Henderson, MD, PhD University of North Carolina
  More Information

No publications provided

Responsible Party: Richard Grossberg, MD, Hattie Larlham Center for Children with Disabilities
ClinicalTrials.gov Identifier: NCT01019122     History of Changes
Other Study ID Numbers: Bone Growth in CP Patients
Study First Received: November 20, 2009
Last Updated: March 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
cerebral palsy
DEXA scan
bone density

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013