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| Sponsor: | University of British Columbia |
|---|---|
| Information provided by (Responsible Party): | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00175708 |
Purpose
The purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment.
| Condition |
|---|
|
Clubfoot |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pedobarographic Assessments of Clubfoot Treated Patients |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Clubfoot patients seen at BC Children's Hospital in Vancouver.
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:
Contacts and Locations| Contact: Harpreet Chhina | 604-875-2000 ext 6008 | hchhina@cw.bc.ca |
| Canada, British Columbia | |
| BC Children's Hospital Department of Orthopaedics | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Harpreet Chhina 604-875-2000 ext 6008 hchhina@cw.bc.ca | |
| Principal Investigator: Christine Alvarez, PhD | |
| Principal Investigator: | Dr. Christine Alvarez | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00175708 History of Changes |
| Other Study ID Numbers: | H03-70531 |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 19, 2011 |
| Health Authority: | Canada: Health Canada |
|
Evaluation of an outcome tool clubfoot foot pressure profiles pedobarographs |
|
Clubfoot Equinus Deformity Foot Deformities, Congenital |
Foot Deformities Musculoskeletal Diseases Foot Deformities, Acquired |
