ClubfootmFABNCT03249805
MiracleFeet Foot Abduction Brace Sensor Trial
A study testing Steenbeek Foot Abduction Brace (SFAB) and MiracleFeet Foot Abduction Brace (mFAB) in people with Clubfoot and Telemedicine, run by MiracleFeet at 1 site in India.
Trial summary
The aim of this study is to determine the effect of a new design of FAB type on compliance and treatment outcomes of idiopathic clubfeet treated by the Ponseti method. Very little literature exists on the effect of brace type or the difference between reported and actual at-home compliance, which is integral to the… Read more about this study
- Who is it for?
- Ages 3 months to 1 year
- Conditions the study is for
- Clubfoot, Telemedicine, Patient Compliance
- What is being tested?
- Steenbeek Foot Abduction Brace (SFAB) and MiracleFeet Foot Abduction Brace (mFAB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 7 Jun 2017to 31 Dec 2018
- Phase
- Interventional
- 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 3 months to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Unilateral or bilateral cases of idiopathic clubfoot in children who have not yet started walking at first presentation, receiving a brace for the first time after successful correction with the Ponseti method of treatment, at the Bai Jerbai Wadia Hospital for Children over a period of 6 months.
Who cannot join
- All children who are already walking at presentation; All children with previous treatment; All children who have used FAB previously; All children treated with surgery other than tenotomy; All children with syndromic or neuropathic cases of clubfoot; All children with atypical clubfoot.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Bai Jerbai Wadia Hospital for Children
Mumbai, Maharashtra, 400012
Alaric Aroojis, MD, +91 9320284402, aaroojis@gmail.com
Rujuta Mehta, MD
About this study
Official title: Efficacy of a New Design of Foot Abduction Brace (FAB) Compared to Standard FAB During Ponseti Treatment of Idiopathic Clubfoot by Measuring Rate of Recurrence and Compliance Using Novel Touch Sensors
The aim of this study is to determine the effect of a new design of FAB type on compliance and treatment outcomes of idiopathic clubfeet treated by the Ponseti method. Very little literature exists on the effect of brace type or the difference between reported and actual at-home compliance, which is integral to the success of treatment with the Ponseti method. Eighty children less than 1 year of age will be enrolled in the study into two arms, using block randomization. These two groups will use two different designs of foot abduction brace (FAB). Outcomes will be measured by number of recurrences per group (using recasting and/or surgical procedures and Pirani score as indicators), time of recurrences (in months), compliance with brace wear using sensors and comparing the data with brace wear reported by parents, and parent satisfaction with FAB (measured on a modified Orthotics and Prosthetics User Sur vey). Enrollment will be on a rolling basis; subjects will be enrolled at their last cast application and followed for approximately 6 months. Recurrences, time of recurrence, parent satisfaction, and reported vs. actual compliance will be analyzed.
Read the detailed description
Clubfoot is the most common birth defect affecting 1 in every 750 live births, that is about 200,000 babies each year globally (80% mainly in developing countries). An estimated average 1 million children are currently living with untreated clubfoot. In India every 10 minutes a child is born with clubfoot i.e. over 50,000 children are born with this deformity every year (1 per 500 birth). The Ponseti Method is now recognized as the accepted standard for the medical treatment of clubfoot. The Ponseti Method is ideally suited for the developing world in that it is inexpensive, non-surgical and the casting component can be completed by trained medical and paramedical personnel. Clubfoot causes the feet of the affected individual to point downward and inward. Left untreated, clubfoot causes a permanent physical disability, preventing the individual from walking normally and limiting his or her mobility. Decreased ambulation can lead to the inability to perform daily tasks, such as going to school, leading to increased dependency and a negative economic impact on the family. Furthermore, deformity caused by neglected clubfoot can lead to limited social integration and stigma for both the individual and the family.
The gold standard of clubfoot treatment is the Ponseti method, which consists of 6-8 weeks of serial castings followed by a percutaneous Tendo Achilles tenotomy in the majority of cases. The casting is followed by the use of a foot abduction brace (FAB) for approximately 4 years. The goal of the treatment is to correct the deformity so that the patient has a functional, painless, plantigrade foot with full mobility without the need for orthotics. The 6-8 weeks of serial casting corrects the clubfoot deformity while the use of the FAB after casting prevents the deformity from reoccurring and is required for successful treatment. Noncompliance of FAB use increases the risk of relapse 17-fold.
Currently, the Steenbeek Foot Abduction Brace (SFAB), a version of the Denis Browne splint, is the only low-cost FAB available. The SFAB is made by hand by artisans, limiting its large-scale production. Furthermore, it can be challenging to put on a child due to the shoes being attached to the bar and lacking a strap in addition to laces, potentially leading to noncompliance.
The more recently developed MiracleFeet Foot Abduction Brace (mFAB) is made of injection molded plastic, making it easy to mass produce, and includes removable shoes with a strap to hold the heel in place, claiming to be more comfortable and easier to use, leading to improved compliance.
The MiracleFeet Foot Abduction Brace (mFAB) is a Denis Browne Splint used for the treatment of clubfoot. Use of the Denis Browne Split is standard in clubfoot treatment and the mFAB complies with the standards for foot abduction braces for clubfoot:
- Adjustable to 65 and 45 degrees to accommodate unilateral and bilateral clubfoot
- 10 degrees dorsiflexion
The mFAB was designed with the following additional features, based on requests from parents and providers:
- Large window to view the heel, ensuring it lays flat in the shoe
- Dorsal strap to secure the heel, allowing the shoe to be tied with two hands
- Removable shoes so that the shoes may be applied and then clipped into the bar
- A flat bottom
- The bar is made of strong injection-modeled plastic, in order to be reused
- The shoes are meant to be worn only by 1 child and then discarded
The mFAB shoes are made of canvas and polyester and the bar and shoe plates are made of ortholite and T90 and are manufactured using the injected-molded plastic process in Batavia, Illinois, USA.
The mFAB has been tested in Nicaragua, Brazil, South Africa and the Philippines and is currently in use in 10 countries. Both braces meet the specifications as detailed by the Ponseti method and the same bracing protocol is used for both.
This study will compare treatment outcomes and compliance using the two brace designs, SFAB and mFAB. We will compare the number and time of recurrences, as well as the reported compliance and actual compliance, which will be measured by novel sensors. Few studies exist that compare brace types or actual versus reported compliance and FABs with sensors are a novel technology. Of the literature that exists, FAB use was show to decline significantly during the first 3 months and actual wear is less than reported wear.
- Conditions
- Clubfoot, Telemedicine, Patient Compliance
- Being tested
- Steenbeek Foot Abduction Brace (SFAB), MiracleFeet Foot Abduction Brace (mFAB)
- Keywords
- LMIC, Medical device efficacy
- 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.
Steenbeek Foot Abduction Brace (SFAB)Device
Also called Denis Browne splint
The FAB will be equipped with discretely hidden sensors; subjects and their families will not be aware of the actual function of the sensor in order to avoid increased compliance due to the sensor. Sensors work on the principle of force-sensing resistor material whose resistance changes when a force or pressure is applied. Force-sensing resistors consist of a conductive polymer, which changes resistance in a predictable manner following application of force to its surface. On the top of braces sole we have fixed force resistive sensor (FSR), which changes resistance whenever force is applied. Threshold of detection is 30-40 gram. The changes of resistance is detected by using micro-controller.
MiracleFeet Foot Abduction Brace (mFAB)Device
Also called Denis Browne splint
Sensors in the mFAB will measure whether the shoe is on, the foot is in contact with the sole of the shoe and the shoes are clipped into the bar. Sensors work on the principle of force-sensing resistor material whose resistance changes when a force or pressure is applied. Force-sensing resistors consist of a conductive polymer, which changes resistance in a predictable manner following application of force to its surface. On the top of braces sole we have fixed force resistive sensor (FSR), which changes resistance whenever force is applied. Threshold of detection is 30-40 gram. The changes of resistance is detected by using micro-controller.
| Study group | Role | What they receive |
|---|---|---|
| Steenbeek Foot Abduction Brace (SFAB) | Experimental | The study will follow the subject for 6 months after their enrollment, beginning at first FAB use. The Steenbeek Foot Abduction Brace (SFAB) is a fixed metal bar attached to two leather shoes with laces. The shoes have laces and a strap. The FABs provide 10 degrees of dorsiflexion and 45 or 65 degrees of abduction, and will be equipped with sensors to measure at-home FAB compliance. After the last cast is removed, a brace will be worn for 23 hours/day for the first 3 months and the time will be gradually decreased thereafter to a 'nights and naps' protocol for a total of 12 hours/day. At follow-up appointments the brace will be checked for fit and Pirani score recorded. Receives: Device: Steenbeek Foot Abduction Brace (SFAB) |
| MiracleFeet Foot Abduction Brace (mFAB) | Experimental | The study will follow the subject for 6 months after their enrollment, beginning at first FAB use. The MiracleFeet Foot Abduction Brace (mFAB) is an injected plastic molded bar with fabric shoes that clip off and on. The shoes have laces and a strap. Both FABs provide 10 degrees of dorsiflexion and 45 or 65 degrees of abduction, and will be equipped with sensors to measure at-home FAB compliance. After the last cast is removed, a brace will be worn for 23 hours/day for the first 3 months and the time will be gradually decreased thereafter to a 'nights and naps' protocol for a total of 12 hours/day. At follow-up appointments the brace will be checked for fit and Pirani score recorded. Receives: Device: MiracleFeet Foot Abduction Brace (mFAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pirani Score
The Pirani score is a standardized tool measuring that severity of clubfoot deformity. It will be assessed at all visits - baseline, during treatment and follow-up - to evaluate gradual recurrence of clubfoot deformity.
Measured: One year
Secondary outcomes (1)
Orthotics Prosthetics User Survey (OPUS) Results
Parent satisfaction with the FABs will be determined by administering an OPUS to them at each follow-up visit.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start7 Jun 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a hospital-based study with single blinding of the investigator. Subjects will be randomized in order to prevent systematic differences between the groups to prevent bias. Our groups will be parallel, there will be no crossover. The two parallel groups will use two different versions of FABs; the Steenbeek Foot Abduction Brace (SFAB) and the MiracleFeet Foot Abduction Brace (mFAB). Both types of FAB will be equipped with discretely hidden sensors; subjects and their families will not be aware of the actual function of the sensor to avoid increased compliance due to the sensor. Due to practical constraints (the brace being visibly identifiable), the study will not be blind. This study will use number of recurrences in the two groups as the primary outcome of interest. Recurrence will be checked for at each scheduled follow-up visit (see schedule below) and recorded in event of occurrence. A process of rolling recruitment will be used until our groups are complete.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiracleFeet
- Sponsor type
- University, hospital or other
- Collaborators
- Bai Jerbai Wadia Hospital for Children, Mumbai, India, Metwiz Materials, CURE, Biomedical Engineering and Technology (Incubation) Center, Bombay
- Responsible party
- Sponsor
- Investigators
- Alaric Aroojis, MD, Principal investigator, Bai Jerbai Wadia Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249805
- Sponsor's protocol ID
- 0001
- Acronym
- mFAB
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ponseti IV. Treatment of congenital club foot. J Bone Joint Surg Am. 1992 Mar;74(3):448-54. No abstract available.
PubMed 1548277Morcuende JA, Dolan LA, Dietz FR, Ponseti IV. Radical reduction in the rate of extensive corrective surgery for clubfoot using the Ponseti method. Pediatrics. 2004 Feb;113(2):376-80. doi: 10.1542/peds.113.2.376.
PubMed 14754952Morgenstein A, Davis R, Talwalkar V, Iwinski H Jr, Walker J, Milbrandt TA. A randomized clinical trial comparing reported and measured wear rates in clubfoot bracing using a novel pressure sensor. J Pediatr Orthop. 2015 Mar;35(2):185-91. doi: 10.1097/BPO.0000000000000205.
PubMed 24787312Zionts LE, Frost N, Kim R, Ebramzadeh E, Sangiorgio SN. Treatment of idiopathic clubfoot: experience with the Mitchell-Ponseti brace. J Pediatr Orthop. 2012 Oct-Nov;32(7):706-13. doi: 10.1097/BPO.0b013e3182694f4d.
PubMed 22955535Boehm S, Sinclair M. Foot abduction brace in the Ponseti method for idiopathic clubfoot deformity: torsional deformities and compliance. J Pediatr Orthop. 2007 Sep;27(6):712-6. doi: 10.1097/BPO.0b013e3181425508.
PubMed 17717477Chen RC, Gordon JE, Luhmann SJ, Schoenecker PL, Dobbs MB. A new dynamic foot abduction orthosis for clubfoot treatment. J Pediatr Orthop. 2007 Jul-Aug;27(5):522-8. doi: 10.1097/bpo.0b013e318070cc19.
PubMed 17585260Garg S, Porter K. Improved bracing compliance in children with clubfeet using a dynamic orthosis. J Child Orthop. 2009 Aug;3(4):271-6. doi: 10.1007/s11832-009-0182-9. Epub 2009 Jun 3.
PubMed 19495824Hemo Y, Segev E, Yavor A, Ovadia D, Wientroub S, Hayek S. The influence of brace type on the success rate of the Ponseti treatment protocol for idiopathic clubfoot. J Child Orthop. 2011 Apr;5(2):115-9. doi: 10.1007/s11832-010-0321-3. Epub 2010 Dec 24.
PubMed 22468155Janicki JA, Wright JG, Weir S, Narayanan UG. A comparison of ankle foot orthoses with foot abduction orthoses to prevent recurrence following correction of idiopathic clubfoot by the Ponseti method. J Bone Joint Surg Br. 2011 May;93(5):700-4. doi: 10.1302/0301-620X.93B5.24883.
PubMed 21511939Kessler JI. A new flexible brace used in the Ponseti treatment of talipes equinovarus. J Pediatr Orthop B. 2008 Sep;17(5):247-50. doi: 10.1097/BPB.0b013e32830cc3e5.
PubMed 19471177Sangiorgio SN, Ho NC, Morgan RD, Ebramzadeh E, Zionts LE. The Objective Measurement of Brace-Use Adherence in the Treatment of Idiopathic Clubfoot. J Bone Joint Surg Am. 2016 Oct 5;98(19):1598-1605. doi: 10.2106/JBJS.16.00170.
PubMed 27707845Thatipelli S, Arun A, Chung P, Etemadi M, Heller J, Kwiat D et al. Review of Existing Brace Adherence Monitoring Methods to Assess Adherence. Journal of Prosthetics and Orthotics. 2016;28(4):126-135.
Manousaki E, Czuba T, Hagglund G, Mattsson L, Andriesse H. Evaluation of gait, relapse and compliance in clubfoot treatment with custom-made orthoses. Gait Posture. 2016 Oct;50:8-13. doi: 10.1016/j.gaitpost.2016.08.005. Epub 2016 Aug 7.
PubMed 27544063Chong DY, Finberg NS, Conklin MJ, Doyle JS, Khoury JG, Gilbert SR. Prospective evaluation of the use of Mitchell shoes and dynamic abduction brace for idiopathic clubfeet. J Pediatr Orthop B. 2014 Nov;23(6):501-4. doi: 10.1097/BPB.0000000000000090.
PubMed 25144885Thacker 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 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a New Design of Foot Abduction Brace (FAB) Compared to Standard FAB During Ponseti Treatment of Idiopathic Clubfoot by Measuring Rate of Recurrence and Compliance Using Novel Touch Sensors
- ClinicalTrials.gov ID
- NCT03249805
- Acronym / sponsor ID
- mFAB / 0001
- Conditions
- Clubfoot, Telemedicine, Patient Compliance
- Keywords
- LMIC, Medical device efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- MiracleFeetUniversity, hospital or other
- Collaborators
- Bai Jerbai Wadia Hospital for Children, Mumbai, India, Metwiz Materials, CURE, Biomedical Engineering and Technology (Incubation) Center, Bombay
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 15 Aug 2017 (actual)
- 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 aim of this study is to determine the effect of a new design of FAB type on compliance and treatment outcomes of idiopathic clubfeet treated by the Ponseti method. Very little literature exists on the effect of brace type or the difference between reported and actual at-home compliance, which is integral to the success of treatment with the Ponseti method. Eighty children less than 1 year of age will be enrolled in the study into two arms, using block randomization. These two groups will use two different designs of foot abduction brace (FAB). Outcomes will be measured by number of recurrences per group (using recasting and/or surgical procedures and Pirani score as indicators), time of recurrences (in months), compliance with brace wear using sensors and comparing the data with brace wear reported by parents, and parent satisfaction with FAB (measured on a modified Orthotics and Prosthetics User Sur vey). Enrollment will be on a rolling basis; subjects will be enrolled at their last cast application and followed for approximately 6 months. Recurrences, time of recurrence, parent satisfaction, and reported vs. actual compliance will be analyzed.
Detailed description
Clubfoot is the most common birth defect affecting 1 in every 750 live births, that is about 200,000 babies each year globally (80% mainly in developing countries). An estimated average 1 million children are currently living with untreated clubfoot. In India every 10 minutes a child is born with clubfoot i.e. over 50,000 children are born with this deformity every year (1 per 500 birth). The Ponseti Method is now recognized as the accepted standard for the medical treatment of clubfoot. The Ponseti Method is ideally suited for the developing world in that it is inexpensive, non-surgical and the casting component can be completed by trained medical and paramedical personnel. Clubfoot causes the feet of the affected individual to point downward and inward. Left untreated, clubfoot causes a permanent physical disability, preventing the individual from walking normally and limiting his or her mobility. Decreased ambulation can lead to the inability to perform daily tasks, such as going to school, leading to increased dependency and a negative economic impact on the family. Furthermore, deformity caused by neglected clubfoot can lead to limited social integration and stigma for both the individual and the family.
The gold standard of clubfoot treatment is the Ponseti method, which consists of 6-8 weeks of serial castings followed by a percutaneous Tendo Achilles tenotomy in the majority of cases. The casting is followed by the use of a foot abduction brace (FAB) for approximately 4 years. The goal of the treatment is to correct the deformity so that the patient has a functional, painless, plantigrade foot with full mobility without the need for orthotics. The 6-8 weeks of serial casting corrects the clubfoot deformity while the use of the FAB after casting prevents the deformity from reoccurring and is required for successful treatment. Noncompliance of FAB use increases the risk of relapse 17-fold.
Currently, the Steenbeek Foot Abduction Brace (SFAB), a version of the Denis Browne splint, is the only low-cost FAB available. The SFAB is made by hand by artisans, limiting its large-scale production. Furthermore, it can be challenging to put on a child due to the shoes being attached to the bar and lacking a strap in addition to laces, potentially leading to noncompliance.
The more recently developed MiracleFeet Foot Abduction Brace (mFAB) is made of injection molded plastic, making it easy to mass produce, and includes removable shoes with a strap to hold the heel in place, claiming to be more comfortable and easier to use, leading to improved compliance.
The MiracleFeet Foot Abduction Brace (mFAB) is a Denis Browne Splint used for the treatment of clubfoot. Use of the Denis Browne Split is standard in clubfoot treatment and the mFAB complies with the standards for foot abduction braces for clubfoot:
- Adjustable to 65 and 45 degrees to accommodate unilateral and bilateral clubfoot
- 10 degrees dorsiflexion
The mFAB was designed with the following additional features, based on requests from parents and providers:
- Large window to view the heel, ensuring it lays flat in the shoe
- Dorsal strap to secure the heel, allowing the shoe to be tied with two hands
- Removable shoes so that the shoes may be applied and then clipped into the bar
- A flat bottom
- The bar is made of strong injection-modeled plastic, in order to be reused
- The shoes are meant to be worn only by 1 child and then discarded
The mFAB shoes are made of canvas and polyester and the bar and shoe plates are made of ortholite and T90 and are manufactured using the injected-molded plastic process in Batavia, Illinois, USA.
The mFAB has been tested in Nicaragua, Brazil, South Africa and the Philippines and is currently in use in 10 countries. Both braces meet the specifications as detailed by the Ponseti method and the same bracing protocol is used for both.
This study will compare treatment outcomes and compliance using the two brace designs, SFAB and mFAB. We will compare the number and time of recurrences, as well as the reported compliance and actual compliance, which will be measured by novel sensors. Few studies exist that compare brace types or actual versus reported compliance and FABs with sensors are a novel technology. Of the literature that exists, FAB use was show to decline significantly during the first 3 months and actual wear is less than reported wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This will be a hospital-based study with single blinding of the investigator. Subjects will be randomized in order to prevent systematic differences between the groups to prevent bias. Our groups will be parallel, there will be no crossover. The two parallel groups will use two different versions of FABs; the Steenbeek Foot Abduction Brace (SFAB) and the MiracleFeet Foot Abduction Brace (mFAB). Both types of FAB will be equipped with discretely hidden sensors; subjects and their families will not be aware of the actual function of the sensor to avoid increased compliance due to the sensor. Due to practical constraints (the brace being visibly identifiable), the study will not be blind. This study will use number of recurrences in the two groups as the primary outcome of interest. Recurrence will be checked for at each scheduled follow-up visit (see schedule below) and recorded in event of occurrence. A process of rolling recruitment will be used until our groups are complete.
| Arm | Type | Receives |
|---|---|---|
| Steenbeek Foot Abduction Brace (SFAB) | Experimental | Device: Steenbeek Foot Abduction Brace (SFAB)The study will follow the subject for 6 months after their enrollment, beginning at first FAB use. The Steenbeek Foot Abduction Brace (SFAB) is a fixed metal bar attached to two leather shoes with laces. The shoes have laces and a strap. The FABs provide 10 degrees of dorsiflexion and 45 or 65 degrees of abduction, and will be equipped with sensors to measure at-home FAB compliance. After the last cast is removed, a brace will be worn for 23 hours/day for the first 3 months and the time will be gradually decreased thereafter to a 'nights and naps' protocol for a total of 12 hours/day. At follow-up appointments the brace will be checked for fit and Pirani score recorded. |
| MiracleFeet Foot Abduction Brace (mFAB) | Experimental | Device: MiracleFeet Foot Abduction Brace (mFAB)The study will follow the subject for 6 months after their enrollment, beginning at first FAB use. The MiracleFeet Foot Abduction Brace (mFAB) is an injected plastic molded bar with fabric shoes that clip off and on. The shoes have laces and a strap. Both FABs provide 10 degrees of dorsiflexion and 45 or 65 degrees of abduction, and will be equipped with sensors to measure at-home FAB compliance. After the last cast is removed, a brace will be worn for 23 hours/day for the first 3 months and the time will be gradually decreased thereafter to a 'nights and naps' protocol for a total of 12 hours/day. At follow-up appointments the brace will be checked for fit and Pirani score recorded. |
Who may qualify
- Ages
- 3 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Unilateral or bilateral cases of idiopathic clubfoot in children who have not yet started walking at first presentation, receiving a brace for the first time after successful correction with the Ponseti method of treatment, at the Bai Jerbai Wadia Hospital for Children over a period of 6 months.
Key exclusion criteria (1 listed)
- All children who are already walking at presentation; All children with previous treatment; All children who have used FAB previously; All children treated with surgery other than tenotomy; All children with syndromic or neuropathic cases of clubfoot; All children with atypical clubfoot.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steenbeek Foot Abduction Brace (SFAB)Also: Denis Browne splintThe FAB will be equipped with discretely hidden sensors; subjects and their families will not be aware of the actual function of the sensor in order to avoid increased compliance due to the sensor. Sensors work on the principle of force-sensing resistor material whose resistance changes when a force or pressure is applied. Force-sensing resistors consist of a conductive polymer, which changes resistance in a predictable manner following application of force to its surface. On the top of braces sole we have fixed force resistive sensor (FSR), which changes resistance whenever force is applied. Threshold of detection is 30-40 gram. The changes of resistance is detected by using micro-controller. | Device | Steenbeek Foot Abduction Brace (SFAB) |
| MiracleFeet Foot Abduction Brace (mFAB)Also: Denis Browne splintSensors in the mFAB will measure whether the shoe is on, the foot is in contact with the sole of the shoe and the shoes are clipped into the bar. Sensors work on the principle of force-sensing resistor material whose resistance changes when a force or pressure is applied. Force-sensing resistors consist of a conductive polymer, which changes resistance in a predictable manner following application of force to its surface. On the top of braces sole we have fixed force resistive sensor (FSR), which changes resistance whenever force is applied. Threshold of detection is 30-40 gram. The changes of resistance is detected by using micro-controller. | Device | MiracleFeet Foot Abduction Brace (mFAB) |
Primary outcome
Change in Pirani Score
Time frame: One year
The Pirani score is a standardized tool measuring that severity of clubfoot deformity. It will be assessed at all visits - baseline, during treatment and follow-up - to evaluate gradual recurrence of clubfoot deformity.
1 secondary outcome
Orthotics Prosthetics User Survey (OPUS) Results
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Background: PubMed 1548277Ponseti IV. Treatment of congenital club foot. J Bone Joint Surg Am. 1992 Mar;74(3):448-54. No abstract available.
- Background: PubMed 14754952Morcuende JA, Dolan LA, Dietz FR, Ponseti IV. Radical reduction in the rate of extensive corrective surgery for clubfoot using the Ponseti method. Pediatrics. 2004 Feb;113(2):376-80. doi: 10.1542/peds.113.2.376.
- Background: PubMed 24787312Morgenstein A, Davis R, Talwalkar V, Iwinski H Jr, Walker J, Milbrandt TA. A randomized clinical trial comparing reported and measured wear rates in clubfoot bracing using a novel pressure sensor. J Pediatr Orthop. 2015 Mar;35(2):185-91. doi: 10.1097/BPO.0000000000000205.
- Background: PubMed 22955535Zionts LE, Frost N, Kim R, Ebramzadeh E, Sangiorgio SN. Treatment of idiopathic clubfoot: experience with the Mitchell-Ponseti brace. J Pediatr Orthop. 2012 Oct-Nov;32(7):706-13. doi: 10.1097/BPO.0b013e3182694f4d.
- Background: PubMed 17717477Boehm S, Sinclair M. Foot abduction brace in the Ponseti method for idiopathic clubfoot deformity: torsional deformities and compliance. J Pediatr Orthop. 2007 Sep;27(6):712-6. doi: 10.1097/BPO.0b013e3181425508.
- Background: PubMed 17585260Chen RC, Gordon JE, Luhmann SJ, Schoenecker PL, Dobbs MB. A new dynamic foot abduction orthosis for clubfoot treatment. J Pediatr Orthop. 2007 Jul-Aug;27(5):522-8. doi: 10.1097/bpo.0b013e318070cc19.
- Background: PubMed 19495824Garg S, Porter K. Improved bracing compliance in children with clubfeet using a dynamic orthosis. J Child Orthop. 2009 Aug;3(4):271-6. doi: 10.1007/s11832-009-0182-9. Epub 2009 Jun 3.
- Background: PubMed 22468155Hemo Y, Segev E, Yavor A, Ovadia D, Wientroub S, Hayek S. The influence of brace type on the success rate of the Ponseti treatment protocol for idiopathic clubfoot. J Child Orthop. 2011 Apr;5(2):115-9. doi: 10.1007/s11832-010-0321-3. Epub 2010 Dec 24.
- Background: PubMed 21511939Janicki JA, Wright JG, Weir S, Narayanan UG. A comparison of ankle foot orthoses with foot abduction orthoses to prevent recurrence following correction of idiopathic clubfoot by the Ponseti method. J Bone Joint Surg Br. 2011 May;93(5):700-4. doi: 10.1302/0301-620X.93B5.24883.
- Background: PubMed 19471177Kessler JI. A new flexible brace used in the Ponseti treatment of talipes equinovarus. J Pediatr Orthop B. 2008 Sep;17(5):247-50. doi: 10.1097/BPB.0b013e32830cc3e5.
- Background: PubMed 27707845Sangiorgio SN, Ho NC, Morgan RD, Ebramzadeh E, Zionts LE. The Objective Measurement of Brace-Use Adherence in the Treatment of Idiopathic Clubfoot. J Bone Joint Surg Am. 2016 Oct 5;98(19):1598-1605. doi: 10.2106/JBJS.16.00170.
- BackgroundThatipelli S, Arun A, Chung P, Etemadi M, Heller J, Kwiat D et al. Review of Existing Brace Adherence Monitoring Methods to Assess Adherence. Journal of Prosthetics and Orthotics. 2016;28(4):126-135.
- Individual participant dataSharing planned: No
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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.
Alaric Aroojis, MD principal investigator
Bai Jerbai Wadia Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steenbeek Foot Abduction Brace (SFAB) and MiracleFeet Foot Abduction Brace (mFAB) in people with Clubfoot and Telemedicine, run by MiracleFeet at 1 site in India.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Aug 2018. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaric Aroojis, MD (+91 9320284402, aaroojis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pirani Score (time frame: One year). 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 NCT03249805, which also lists 18 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 17 Aug 2018.