ClubfootNCT00175708
Pedobarographic Assessments of Clubfoot Treated Patients
An observational study of Clubfoot, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment. Read more about this study
- Who is it for?
- Ages 18 months to 5 years
- Conditions the study is for
- Clubfoot
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Clubfoot patients seen at BC Children's Hospital in Vancouver.
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital Department of Orthopaedics
Vancouver, British Columbia, V6H 3V4
About this study
The purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment.
Read the 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.
- Conditions
- Clubfoot
- Keywords
- Evaluation of an outcome tool, clubfoot, foot pressure profiles, pedobarographs
- Medical subject headings
- Clubfoot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJun 2016
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Alvarez, University of British Columbia
- Investigators
- Dr. Christine Alvarez, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175708
- Sponsor's protocol ID
- H03-70531
- Status last verified
- May 2017
- First submitted
- 13 Sep 2005
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedobarographic Assessments of Clubfoot Treated Patients
- ClinicalTrials.gov ID
- NCT00175708
- Acronym / sponsor ID
- H03-70531
- Conditions
- Clubfoot
- Keywords
- Evaluation of an outcome tool, clubfoot, foot pressure profiles, pedobarographs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Clubfoot patients seen at BC Children's Hospital in Vancouver.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Related trials for Clubfoot
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Flat Feet, Lower-Limb Muscle Activation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Christine Alvarez principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.