Pedobarographic Assessments of Clubfoot Treated Patients

This study is currently recruiting participants.

Verified October 2011 by University of British Columbia

First Received on September 13, 2005. Last Updated on October 19, 2011 History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health

U.S. FDA Resources

Further study details as provided by University of British Columbia:

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:

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

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

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:	October 19, 2011
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
Foot Deformities, Acquired

ClinicalTrials.gov processed this record on February 12, 2012