MiracleFeet Foot Abduction Brace Sensor Trial

NCT03249805 | Unknown FDA Device

• 1 other identifier: 0001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Clubfoot; Telemedicine; Patient Compliance

Keywords

LMIC; Medical device efficacy

Outcome Measures

Primary Outcomes (1)

• 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.

  One year

Secondary Outcomes (1)

• Orthotics Prosthetics User Survey (OPUS) Results

  One year

Other Outcomes (1)

• Minutes of brace usage per day

  One year

Study Arms (2)

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.

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.

Device: MiracleFeet Foot Abduction Brace (mFAB)

Interventions

Steenbeek Foot Abduction Brace (SFAB) DEVICE

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.

Also known as: Denis Browne splint

Steenbeek Foot Abduction Brace (SFAB)

MiracleFeet Foot Abduction Brace (mFAB) DEVICE

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.

Also known as: Denis Browne splint

MiracleFeet Foot Abduction Brace (mFAB)

Eligibility Criteria

• Age: 3 Months - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MiracleFeet: lead
• Bai Jerbai Wadia Hospital for Children, Mumbai, India: collaborator
• Metwiz Materials: collaborator
• CURE: collaborator
• Biomedical Engineering and Technology (Incubation) Center, Bombay: collaborator

Study Sites (1)

Bai Jerbai Wadia Hospital for Children

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (18)

• Ponseti IV. Treatment of congenital club foot. J Bone Joint Surg Am. 1992 Mar;74(3):448-54. No abstract available.

  PMID: 1548277 BACKGROUND

• Morcuende 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.

  PMID: 14754952 BACKGROUND

• Morgenstein 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.

  PMID: 24787312 BACKGROUND

• Zionts 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.

  PMID: 22955535 BACKGROUND

• Boehm 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.

  PMID: 17717477 BACKGROUND

• Chen 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.

  PMID: 17585260 BACKGROUND

• Garg 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.

  PMID: 19495824 BACKGROUND

• Hemo 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.

  PMID: 22468155 BACKGROUND

• Janicki 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.

  PMID: 21511939 BACKGROUND

• Kessler 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.

  PMID: 19471177 BACKGROUND

• Sangiorgio 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.

  PMID: 27707845 BACKGROUND

• Thatipelli 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.

  BACKGROUND

• 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.

  PMID: 27544063 BACKGROUND

• Chong 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.

  PMID: 25144885 BACKGROUND

• Thacker 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.

  PMID: 15718907 BACKGROUND

• Ramirez N, Flynn JM, Fernandez S, Seda W, Macchiavelli RE. Orthosis noncompliance after the Ponseti method for the treatment of idiopathic clubfeet: a relevant problem that needs reevaluation. J Pediatr Orthop. 2011 Sep;31(6):710-5. doi: 10.1097/BPO.0b013e318221eaa1.

  PMID: 21841450 BACKGROUND

• Bouchoucha S, Smida M, Saied W, Safi H, Ammar C, Nessib MN, Ghachem MB. Early results of the Ponseti method using the Steenbek foot abduction brace: a prospective study of 95 feet. J Pediatr Orthop B. 2008 May;17(3):134-8. doi: 10.1097/BPB.0b013e3282fa5f0d.

  PMID: 18391812 BACKGROUND

• Desai L, Oprescu F, DiMeo A, Morcuende JA. Bracing in the treatment of children with clubfoot: past, present, and future. Iowa Orthop J. 2010;30:15-23.

  PMID: 21045966 BACKGROUND

MeSH Terms

Conditions

Clubfoot; Patient Compliance

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Alaric Aroojis, MD

  Bai Jerbai Wadia Hospital for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaric Aroojis, MD

CONTACT

+91 9320284402; aaroojis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 15, 2017
• Study Start: June 7, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)