A clinical trial to study the effectiveness of a new design of foot brace compared to standard foot brace following plaster treatment of clubfoot using novel touch sensors
Not Applicable
- Conditions
- Health Condition 1: null- Clubfoot
- Registration Number
- CTRI/2017/09/009590
- Lead Sponsor
- Bai Jerbai Wadia Hospital for Children
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Unilateral or bilateral cases of idiopathic clubfoot in children who have not yet started walking at first presentation ( <1 year of age), 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 ( >1 year of age); 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pirani ScoreTimepoint: Every month for six months
- Secondary Outcome Measures
Name Time Method Minutes of brace usageTimepoint: Every month for six months;Orthotics Prosthetics User Survey (OPUS)Timepoint: Every month for six months