Purpose

The purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment.


Condition
Clubfoot

MedlinePlus related topics:   Foot Health  

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Longitudinal, Defined Population, Prospective Study
Official Title:   Pedobarographic Assessments of Clubfoot Treated Patients

Further study details as provided by University of British Columbia:

Estimated Enrollment:   100
Estimated Study Completion Date:   September 2009

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%u2019 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

Criteria

Inclusion Criteria:

Inclusion criteria %u2013 all clubfoot patients seen at BC Children%u2019s 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175708

Contacts
Contact: Mary De Vera     604-875-2000 ext 6008     mdevera@cw.bc.ca    

Locations
Canada, British Columbia
BC Children%u2019s Hospital Department of Orthopaedics     Recruiting
      Vancouver, British Columbia, Canada, V6H 3V4
      Contact: Mary De Vera     604-875-2000 ext 6008     mdevera@cw.bc.ca    
      Principal Investigator: Christine Alvarez, PhD            

Sponsors and Collaborators
University of British Columbia

Investigators
Principal Investigator:     Dr. Christine Alvarez     University of British Columbia    
Contact: Mary De Vera     604-875-2000 ext 6008     mdevera@cw.bc.ca    
Canada, British Columbia
BC Children%u2019s Hospital Department of Orthopaedics     Recruiting
      Vancouver, British Columbia, Canada, V6H 3V4
      Contact: Mary De Vera     604-875-2000 ext 6008     mdevera@cw.bc.ca    
      Principal Investigator: Christine Alvarez, PhD            
University of British Columbia
Principal Investigator:     Dr. Christine Alvarez     University of British Columbia    
  More Information

Study ID Numbers:   C03-0531
First Received:   September 13, 2005
Last Updated:   September 13, 2005
ClinicalTrials.gov Identifier:   NCT00175708
Health Authority:   Canada: Health Canada

Keywords provided by University of British Columbia:
Evaluation of an outcome tool  
clubfoot  
foot pressure profiles  
pedobarographs  

Study placed in the following topic categories:
Musculoskeletal Diseases
Talipes equinovarus
Clubfoot
Equinus Deformity
Congenital Abnormalities
Foot Deformities

Additional relevant MeSH terms:
Foot Deformities, Acquired
Clubfoot
Foot Deformities, Congenital
Equinus Deformity

Source: National Library of Medicine (NLM) July 07, 2008