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Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01019122
Recruitment Status : Completed
First Posted : November 24, 2009
Last Update Posted : March 10, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cerebral Palsy Bone Density Radiation: Dexa Scan

Study Design

Study Type : Observational
Estimated Enrollment : 56 participants
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
Study Start Date : October 2009
Primary Completion Date : July 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Dual Energy X-ray Absorptiometry (DEXA) scan results [ Time Frame: 6 years from original DEXA scan ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 24, 2009    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011

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

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