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MiracleFeet Foot Abduction Brace Sensor Trial (mFAB)

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ClinicalTrials.gov Identifier: NCT03249805
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : August 17, 2018
Sponsor:
Collaborators:
Bai Jerbai Wadia Hospital for Children, Mumbai, India
Metwiz Materials
CURE
Biomedical Engineering and Technology (Incubation) Center, Bombay
Information provided by (Responsible Party):
MiracleFeet

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.

Condition or disease Intervention/treatment Phase
Clubfoot Telemedicine Patient Compliance Device: Steenbeek Foot Abduction Brace (SFAB) Device: MiracleFeet Foot Abduction Brace (mFAB) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: 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.
Device: Steenbeek Foot Abduction Brace (SFAB)
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.
Other Name: Denis Browne splint

Experimental: 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.
Device: MiracleFeet Foot Abduction Brace (mFAB)
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.
Other Name: Denis Browne splint




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Orthotics Prosthetics User Survey (OPUS) Results [ Time Frame: One year ]
    Parent satisfaction with the FABs will be determined by administering an OPUS to them at each follow-up visit.


Other Outcome Measures:
  1. Minutes of brace usage per day [ Time Frame: One year ]
    To measure at-home brace use compliance, the sensor data will be collected and compared to parent-reported brace usage. This will be tabulated in number of minutes the brace is used per day, collected at each follow-up visit.



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Ages Eligible for Study:   3 Months to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249805


Contacts
Contact: Alaric Aroojis, MD +91 9320284402 aaroojis@gmail.com

Locations
India
Bai Jerbai Wadia Hospital for Children Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Alaric Aroojis, MD    +91 9320284402    aaroojis@gmail.com   
Sub-Investigator: Rujuta Mehta, MD         
Sub-Investigator: Avi Shah, MD         
Sub-Investigator: Nelson Muthu, PhD         
Sponsors and Collaborators
MiracleFeet
Bai Jerbai Wadia Hospital for Children, Mumbai, India
Metwiz Materials
CURE
Biomedical Engineering and Technology (Incubation) Center, Bombay
Investigators
Principal Investigator: Alaric Aroojis, MD Bai Jerbai Wadia Hospital for Children

Publications:
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.

Responsible Party: MiracleFeet
ClinicalTrials.gov Identifier: NCT03249805     History of Changes
Other Study ID Numbers: 0001
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by MiracleFeet:
LMIC
Medical device efficacy

Additional relevant MeSH terms:
Clubfoot
Talipes
Equinus Deformity
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities