Pedobarographic Assessments of Clubfoot Treated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00175708
Recruitment Status : Unknown
Verified May 2016 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : June 1, 2016
Information provided by (Responsible Party):
University of British Columbia

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

Condition or disease

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pedobarographic Assessments of Clubfoot Treated Patients
Study Start Date : September 2005
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00175708

Contact: Harpreet Chhina 604-875-2000 ext 6008

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   
Principal Investigator: Christine Alvarez, PhD         
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Dr. Christine Alvarez University of British Columbia

Responsible Party: University of British Columbia Identifier: NCT00175708     History of Changes
Other Study ID Numbers: H03-70531
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016

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

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