Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Longitudinal Assessment of Bone Growth and Development in a Facility-Based Population of Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019122
• Other study ID #: Bone Growth in CP Patients
• Status: Completed
• Phase: N/A
• First received: November 20, 2009
• Last updated: March 8, 2011
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2011
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Density
• Cerebral Palsy

Intervention

Radiation:
• Dexa Scan
Dexa scan of left and right distal femur, then lumbar spine, and whole body when possible

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Akron Children's Hospital	Alfred I. duPont Hospital for Children, Kent State University, University of North Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dual Energy X-ray Absorptiometry (DEXA) scan results		6 years from original DEXA scan	No