Pedobarographic Assessments of Clubfoot Treated Patients
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pedobarographic Assessments of Clubfoot Treated Patients|
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Detailed Description: Using Tekscan's HRMat Pressure assessment system or EMED pedobarography system the distribution of force will be measured across the plantar surface of the subject' foot. The Tekscan 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.
The EMED-x400 sensor is rectangular and its dimensions are 47.5 cm by 32 cm. Measurements of force will be recorded at up to rates of 400 Hz. Foam pieces (included with the EMED platform) are constructed around the platform to establish a levelled and safe runway for the patient to walk along. The EMED platform is connected to a computer interface which operates on the Novel analysis software. The subject will be asked to walk across the mat independently at their ordinary pace. The foot is required to land in the centre of the mat, at a minimum of three trials per foot10. Plantar pressure recording takes 10-20 minutes for each subject.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175708
|Contact: Harpreet Chhina||604-875-2000 ext firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Christine Alvarez, PhD|
|Principal Investigator:||Dr. Christine Alvarez||University of British Columbia|