Cerebral PalsyNCT01019122
Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Bone Density, run by Akron Children's Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy, Bone Density
- What is being tested?
- Dexa Scan
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents of a long-term care facility for children with disabilities who have severe to profound CP and are non-ambulatory.
Who may be able to join
- 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
Who cannot join
- Resident of HLCCD who was not enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study
About this study
Official title: 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.
- Conditions
- Cerebral Palsy, Bone Density
- Being tested
- Dexa Scan
- Keywords
- cerebral palsy, DEXA scan, bone density
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexa ScanRadiation
Dexa scan of left and right distal femur, then lumbar spine, and whole body when possible
| Study group | Role | What they receive |
|---|---|---|
| Dexa Scan | Eligible patients from 2003 study will receive a follow-up Dexa scan. Receives: Radiation: Dexa Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Energy X-ray Absorptiometry (DEXA) scan results
Measured: 6 years from original DEXA scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kent State University, University of North Carolina, Alfred I. duPont Hospital for Children
- Investigators
- Martha Blackford, PharmD, Study chair, Akron Children's HospitalMichael Reed, PharmD, Study chair, Akron Children's HospitalRichard Henderson, MD, PhD, Study chair, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019122
- Sponsor's protocol ID
- Bone Growth in CP Patients
- Status last verified
- Mar 2011
- First submitted
- 20 Nov 2009
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Bone Growth and Development in a Facility-Based Population of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01019122
- Acronym / sponsor ID
- Bone Growth in CP Patients
- Conditions
- Cerebral Palsy, Bone Density
- Keywords
- cerebral palsy, DEXA scan, bone density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Collaborators
- Kent State University, University of North Carolina, Alfred I. duPont Hospital for Children
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 24 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexa Scan | – | Radiation: Dexa ScanEligible patients from 2003 study will receive a follow-up Dexa scan. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of a long-term care facility for children with disabilities who have severe to profound CP and are non-ambulatory.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Resident of HLCCD who was not enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexa ScanDexa scan of left and right distal femur, then lumbar spine, and whole body when possible | Radiation | Dexa Scan |
Primary outcome
Dual Energy X-ray Absorptiometry (DEXA) scan results
Time frame: 6 years from original DEXA scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Blackford, PharmD study chair
Akron Children's Hospital
Michael Reed, PharmD study chair
Akron Children's Hospital
Richard Henderson, MD, PhD study chair
University of North Carolina
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Bone Density, run by Akron Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual Energy X-ray Absorptiometry (DEXA) scan results (time frame: 6 years from original DEXA scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2011.