Feasibility study of an orthosis for treatment of a Clubfoot
Withdrawn
- Conditions
- clubfoot10028396
- Registration Number
- NL-OMON52544
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
• A moderate to severe clubfoot deformity according to the Dimeglio scoring
system (grade II or III)
• Start of the Ponseti treatment within 2 weeks after birth
• No other deformities of the foot or leg
• Written informed consent
Exclusion Criteria
• previously treated by the Ponseti method
• characterised by grade IV according to the Dimeglio scoring system
• have other health complications, because they could interfere with the
results of the brace
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcomes are amount of correction defined by the Dimeglio and<br /><br>Pirani score, time needed for treatment and malfunctioning of the brace.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome measure is physical complications of the treatment,<br /><br>caused by the brace.</p><br>