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| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | August 27, 2008 | ||||
| Start Date ICMJE | September 2005 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00175708 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pedobarographic Assessments of Clubfoot Treated Patients | ||||
| Official Title ICMJE | Pedobarographic Assessments of Clubfoot Treated Patients | ||||
| Brief Summary | The purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment. |
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| Detailed Description | Detailed Description: Using Tekscan's HRMat Pressure assessment system the distribution of force will be measured across the plantar surface of the subject' foot. The system is comprised of a 50 cm square pressure sensor connected to a computer interface. The data collection will be made up of two parts: Part I: Static Profile: The child will be asked to stand on the mat for 6 seconds for five trials. During this time the data collection software will collect force data across the foot 60 times per second. The software will then calculate centre of force as well as changes in pressure during the static trial. The foot will be assessed into the distribution of forces across the hindfoot, midfoot, forefoot, and the big toe. In addition, the centre of gravity will also be determined. Part II: Dynamic Profile: The dynamic test will involve the child walking across the mat for a total of 5 passes per foot. Measurements of force will again be taken at 60 Hz. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Clubfoot | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion criteria - all clubfoot patients seen at BC Children's Hospital who have commenced walking and compliant to the study protocol. As the goal of the study is to evaluate the utility of pedobarographs in evaluating clubfoot treatment, we will be following subjects with all presentations of clubfoot (this includes idiopathic clubfoot and clubfoot that is secondary to another global disorder). Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | 18 Months to 5 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00175708 | ||||
| Responsible Party | Dr. Christine Alvarez, University of British Columbia | ||||
| Study ID Numbers ICMJE | C03-0531 | ||||
| Study Sponsor ICMJE | University of British Columbia | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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