Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175708
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2005-09-13
Brief Title:
Pedobarographic Assessments of Clubfoot Treated Patients
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Pedobarographic Assessments of Clubfoot Treated Patients
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment
Detailed Description:
Detailed Description Using Tekscans 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 475 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
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 475 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None