NCT01019122

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 10, 2011

Status Verified

March 1, 2011

Enrollment Period

9 months

First QC Date

November 20, 2009

Last Update Submit

March 8, 2011

Conditions

Cerebral PalsyBone Density

Keywords

cerebral palsyDEXA scanbone density

Outcome Measures

Primary Outcomes (1)

  • Dual Energy X-ray Absorptiometry (DEXA) scan results

    6 years from original DEXA scan

Study Arms (1)

Dexa Scan

Eligible patients from 2003 study will receive a follow-up Dexa scan.

Radiation: Dexa Scan

Interventions

Dexa ScanRADIATION

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

Dexa Scan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Resident of HLCCD who was not enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 24, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2010

Study Completion

November 1, 2010

Last Updated

March 10, 2011

Record last verified: 2011-03