Pedobarographic Assessments of Clubfoot Treated Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175708
First received: September 13, 2005
Last updated: August 20, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Estimated Enrollment: 100
Study Start Date: September 2005
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Clubfoot patients seen at BC Children's Hospital in Vancouver.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Harpreet Chhina 604-875-2000 ext 6008 hchhina@cw.bc.ca

Locations
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         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Dr. Christine Alvarez University of British Columbia
  More Information

No publications provided

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: August 20, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Clubfoot
Equinus Deformity
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Foot Deformities, Acquired

ClinicalTrials.gov processed this record on August 28, 2014