ClubfootNCT01481324
Outcomes of Compliance With Brace Wear in Clubfoot
An observational study of Clubfoot, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
It has been shown that compliance with brace wear can significantly improve the treatment outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be around 30-41% with initial orthosis wear after successful treatment with serial castings. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Clubfoot
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: All clubfoot patients scheduled to be placed in a foot ankle orthosis (FAO)
Who may be able to join
- Unilateral or bilateral clubfoot
- Birth to 3 years of age
- Has been successfully treated with Ponseti casting protocol
Who cannot join
- Any other prior treatment for clubfoot
- Other existing diagnoses or conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children
Lexington, Kentucky, 40502
About this study
Official title: Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor
It has been shown that compliance with brace wear can significantly improve the treatment outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be around 30-41% with initial orthosis wear after successful treatment with serial castings. These studies have depended on family logs and not objective data. With the development of a monitoring device, this study hopes to examine: (1) actual patient compliance, (2) comparisons of actual wear time and assumed wear time and (3) the relationship of patient wear with clinical outcomes.
Hypothesis:
Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported compliance and noncompliance is correlated to future surgeries.
Read the detailed description
It is necessary that treatment teams avoid making any assumptions about patient compliance. This study will objectively measure brace wear-rate in patients with clubfoot that have already been prescribed a foot ankle orthosis. The use of a monitoring device will be able to give objective data on actual patient compliance with brace wear. It is hypothesized that objective compliance data will allow physicians to better assess the patient's therapy progress and outcome, troubleshoot problems or issues associated with barriers to brace wear, and better educate families confronted with having a child with clubfoot. Long term goals will then attempt to determine whether certain brace designs can increase wear time thus decreasing the rate of clubfoot recurrence.
- Conditions
- Clubfoot
- Keywords
- Clubfoot, Compliance, Brace wear
- Medical subject headings
- Clubfoot, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Functioning Pressure Sensor Group | This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning. | |
| Non-Functioning Pressure Sensor Group | This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning. | |
| No Sensor Group | This group will not have a pressure sensor placed on the foot ankle orthosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ClubfootStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- Kosair Charities, Inc.
- Responsible party
- Principal investigator, Todd Milbrandt, Shriners Hospitals for Children
- Investigators
- Todd A Milbrandt, MD, Principal investigator, Shriners Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481324
- Sponsor's protocol ID
- SHC-Lex-101
- Status last verified
- Nov 2014
- First submitted
- 15 Nov 2011
- Last updated
- 24 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Changulani M, Garg NK, Rajagopal TS, Bass A, Nayagam SN, Sampath J, Bruce CE. Treatment of idiopathic club foot using the Ponseti method. Initial experience. J Bone Joint Surg Br. 2006 Oct;88(10):1385-7. doi: 10.1302/0301-620X.88B10.17578.
PubMed 17012432Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64.
PubMed 10934626Haft GF, Walker CG, Crawford HA. Early clubfoot recurrence after use of the Ponseti method in a New Zealand population. J Bone Joint Surg Am. 2007 Mar;89(3):487-93. doi: 10.2106/JBJS.F.00169.
PubMed 17332096Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, Gurnett CA. Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet. J Bone Joint Surg Am. 2004 Jan;86(1):22-7. doi: 10.2106/00004623-200401000-00005.
PubMed 14711941Thacker MM, Scher DM, Sala DA, van Bosse HJ, Feldman DS, Lehman WB. Use of the foot abduction orthosis following Ponseti casts: is it essential? J Pediatr Orthop. 2005 Mar-Apr;25(2):225-8. doi: 10.1097/01.bpo.0000150814.56790.f9.
PubMed 15718907
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor
- ClinicalTrials.gov ID
- NCT01481324
- Acronym / sponsor ID
- SHC-Lex-101
- Conditions
- Clubfoot
- Keywords
- Clubfoot, Compliance, Brace wear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- Kosair Charities, Inc.
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Posted 24 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been shown that compliance with brace wear can significantly improve the treatment outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be around 30-41% with initial orthosis wear after successful treatment with serial castings. These studies have depended on family logs and not objective data. With the development of a monitoring device, this study hopes to examine: (1) actual patient compliance, (2) comparisons of actual wear time and assumed wear time and (3) the relationship of patient wear with clinical outcomes.
Hypothesis:
Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported compliance and noncompliance is correlated to future surgeries.
Detailed description
It is necessary that treatment teams avoid making any assumptions about patient compliance. This study will objectively measure brace wear-rate in patients with clubfoot that have already been prescribed a foot ankle orthosis. The use of a monitoring device will be able to give objective data on actual patient compliance with brace wear. It is hypothesized that objective compliance data will allow physicians to better assess the patient's therapy progress and outcome, troubleshoot problems or issues associated with barriers to brace wear, and better educate families confronted with having a child with clubfoot. Long term goals will then attempt to determine whether certain brace designs can increase wear time thus decreasing the rate of clubfoot recurrence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functioning Pressure Sensor Group | – | –This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning. |
| Non-Functioning Pressure Sensor Group | – | –This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning. |
| No Sensor Group | – | –This group will not have a pressure sensor placed on the foot ankle orthosis. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All clubfoot patients scheduled to be placed in a foot ankle orthosis (FAO)
Key inclusion criteria (3 listed)
- Unilateral or bilateral clubfoot
- Birth to 3 years of age
- Has been successfully treated with Ponseti casting protocol
Key exclusion criteria (2 listed)
- Any other prior treatment for clubfoot
- Other existing diagnoses or conditions
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
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
Time frame: 3 months
Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17012432Changulani M, Garg NK, Rajagopal TS, Bass A, Nayagam SN, Sampath J, Bruce CE. Treatment of idiopathic club foot using the Ponseti method. Initial experience. J Bone Joint Surg Br. 2006 Oct;88(10):1385-7. doi: 10.1302/0301-620X.88B10.17578.
- Background: PubMed 10934626Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64.
- Background: PubMed 17332096Haft GF, Walker CG, Crawford HA. Early clubfoot recurrence after use of the Ponseti method in a New Zealand population. J Bone Joint Surg Am. 2007 Mar;89(3):487-93. doi: 10.2106/JBJS.F.00169.
- Background: PubMed 14711941Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, Gurnett CA. Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet. J Bone Joint Surg Am. 2004 Jan;86(1):22-7. doi: 10.2106/00004623-200401000-00005.
- Background: PubMed 15718907Thacker MM, Scher DM, Sala DA, van Bosse HJ, Feldman DS, Lehman WB. Use of the foot abduction orthosis following Ponseti casts: is it essential? J Pediatr Orthop. 2005 Mar-Apr;25(2):225-8. doi: 10.1097/01.bpo.0000150814.56790.f9.
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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.
Todd A Milbrandt, MD principal investigator
Shriners Hospital for Children
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 Shriners Hospitals for Children at 1 site in United States.
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 3 inclusion and 2 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 24 Nov 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481324, which also lists 5 linked publications.
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 24 Nov 2014; AzTrials last refreshed its copy on 8 Nov 2026.