Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy

March 8, 2011 updated by: Akron Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

56

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dual Energy X-ray Absorptiometry (DEXA) scan results
Time Frame: 6 years from original DEXA scan
6 years from original DEXA scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akron Children's Hospital

Collaborators

Alfred I. duPont Hospital for Children
University of North Carolina
Kent State University

Investigators

  • Study Chair: Michael Reed, PharmD, Akron Children's Hospital
  • Study Chair: Richard Henderson, MD, PhD, University of North Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 24, 2009

Study Record Updates

Last Update Posted (Estimate)

March 10, 2011

Last Update Submitted That Met QC Criteria

March 8, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bone Growth in CP Patients

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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