- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01019122
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.
|
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
Collaborators
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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