An interventional study of Ankle Foot Orthosis (AFO) in Congenital Talipes Equinovarus, sponsored by Medical College of Wisconsin. Terminated at 1 site in United States. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
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Among 10 studies in Clubfoot with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Clubfoot · United States.
Among the 10 studies in Clubfoot with a site in United States, this one is the only one that started in 2019, is one of 3 with no phase, and was the 8th registered.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
Browse Clubfoot studies →2 of the 10 studies in Clubfoot with a site in United States are open now. Recruiting first, the newest first:
University of Wisconsin, Madison · Sites in United States
Ages 0 wk–12 wk
Texas Scottish Rite Hospital for Children · Sites in United States
Ages up to 18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 10 Clubfoot studies recruiting now, none (0%) set no upper age limit and 10 (100%) stop at 75 or younger; 9 take children under 18; none take healthy volunteers.
This study: Up to 12 Months · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2019.
This study's enrollment of 3 is below the median of 38 across 40 interventional studies indexed under Clubfoot.
Median enrollment 100 across the 5 interventional studies, 370 across the 5 observational. Of the 8 that completed or were terminated, 4 (50%) have results posted.
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None of the 10 has an industry lead sponsor. The 8 most frequent:
Medical College of Wisconsin is the lead sponsor of 549 studies on the registry; 123 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
Medical College of Wisconsin has 1 study filed under Clubfoot — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Clubfoot with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study will examine the use of a novel customized Ankle Foot Orthosis (AFO), created using 3D scanning, with children being treated for clubfoot. The AFO is inserted in the standard Mitchell shoe during bracing, following Ponseti casting. The investigators hypothesize that following Ponseti casting, the implementation of customized AFOs with Ponseti bracing will improve patient compliance and functional outcomes as well as lead to fewer relapses in comparison to the standard bracing with Mitchell shoes.
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Exclusion Criteria:
Group will receive standard Mitchell shoes along with the custom orthotic insert.
Device: Ankle Foot Orthosis (AFO)
Group will receive standard treatment which includes bracing with standard Mitchell shoes (no custom orthotic). Patients would receive this treatment regardless of study participation.
The intervention group will receive the custom AFO to use in their standard Mitchell shoe.
Assessment of Functional Outcomes of Bracing Treatment Using Dimeglio Scores
Assessed using changes in Dimeglio Scores. The Dimeglio scoring system uses a 20-point system (20 being the most severe and \<5 as benign) by assessing four parameters. The severity of the deformity is then assigned a grade of I-IV with IV being the most severe. (A score of \<5 is given a grade of I, =5\<10 is grade II, =10\<15 is grade III, and =15\<20 is grade IV)
Time frame: Collected when visit where cast is applied, visit when cast is removed, then at 2 weeks, 12 weeks, 24 weeks of bracing
Time Spent in Brace to Assess Brace Compliance
Measured with sensor placed in Mitchell shoe
Time frame: 24 weeks (from start of bracing treatment)
Assessing Treatment Factors that Impact Brace Compliance with Parental Questionnaires
Assessing reasons for poor compliance with parental questionnaires. The questionnaires ask questions about casting, occurrences of skin lesions, history of treatments, bracing information, reasons for not using brace, and brace slippage
Time frame: 24 weeks (from start of bracing treatment)
Assessing Demographic Factors that Impact Brace Compliance with Parental Questionnaire
The initial questionnaire asks questions about parental demographics to determine what factors may influence brace treatment compliance
Time frame: 24 weeks (from start of bracing treatment)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2019 to primary completion in Mar 2022, 34 months.
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This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin →