Congenital Talipes EquinovarusNCT03853811
Customized Orthosis for Children With Clubfoot
A study testing Ankle Foot Orthosis (AFO) in people with Congenital Talipes Equinovarus, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Congenital Talipes Equinovarus
- What is being tested?
- Ankle Foot Orthosis (AFO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2019to 2 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- less than 12 months old (no age minimum)
- no neuromuscular disease involved
- treated by Ponseti casting
- idiopathic bilateral or unilateral clubfoot
- no other congenital foot deformity
- no previous open surgeries to treat the deformity
Who cannot join
- patients with prior surgical treatment
- not treated by Ponseti casting
- an underlying syndrome
- neurological disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Customized Orthosis for Children With Clubfoot Following Ponseti Casting
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.
- Conditions
- Congenital Talipes Equinovarus
- Being tested
- Ankle Foot Orthosis (AFO)
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Foot Orthosis (AFO)Device
The intervention group will receive the custom AFO to use in their standard Mitchell shoe.
| Study group | Role | What they receive |
|---|---|---|
| Mitchell Shoe + AFO | Experimental | Group will receive standard Mitchell shoes along with the custom orthotic insert. Receives: Device: Ankle Foot Orthosis (AFO) |
| Standard Mitchell Shoe (Control - Standard Treatment) | No intervention | Group will receive standard treatment which includes bracing with standard Mitchell shoes (no custom orthotic). Patients would receive this treatment regardless of study participation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 24 weeks (from start of bracing treatment)
Secondary outcomes (1)
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
Measured: 24 weeks (from start of bracing treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start17 Apr 2019
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Why it stopped: Insufficient resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Talipes EquinovarusStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Van Valin, Medical College of Wisconsin
- Investigators
- Scott Van Valin, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853811
- Sponsor's protocol ID
- 1246407
- Status last verified
- Apr 2022
- First submitted
- 20 Jan 2019
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Orthosis for Children With Clubfoot Following Ponseti Casting
- ClinicalTrials.gov ID
- NCT03853811
- Acronym / sponsor ID
- 1246407
- Conditions
- Congenital Talipes Equinovarus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient resources
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitchell Shoe + AFO | Experimental | Device: Ankle Foot Orthosis (AFO)Group will receive standard Mitchell shoes along with the custom orthotic insert. |
| Standard Mitchell Shoe (Control - Standard Treatment) | No intervention | –Group will receive standard treatment which includes bracing with standard Mitchell shoes (no custom orthotic). Patients would receive this treatment regardless of study participation. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- less than 12 months old (no age minimum)
- no neuromuscular disease involved
- treated by Ponseti casting
- idiopathic bilateral or unilateral clubfoot
- no other congenital foot deformity
Key exclusion criteria (4 listed)
- patients with prior surgical treatment
- not treated by Ponseti casting
- an underlying syndrome
- neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle Foot Orthosis (AFO)The intervention group will receive the custom AFO to use in their standard Mitchell shoe. | Device | Mitchell Shoe + AFO |
Primary outcome
Assessment of Functional Outcomes of Bracing Treatment Using Dimeglio Scores
Time frame: Collected when visit where cast is applied, visit when cast is removed, then at 2 weeks, 12 weeks, 24 weeks of bracing
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 Spent in Brace to Assess Brace Compliance
Time frame: 24 weeks (from start of bracing treatment)
Measured with sensor placed in Mitchell shoe
Assessing Treatment Factors that Impact Brace Compliance with Parental Questionnaires
Time frame: 24 weeks (from start of bracing treatment)
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
1 secondary outcome
Assessing Demographic Factors that Impact Brace Compliance with Parental Questionnaire
Time frame: 24 weeks (from start of bracing treatment)
Results and safety
The study was stopped early (reason given: Insufficient resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Van Valin, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Foot Orthosis (AFO) in people with Congenital Talipes Equinovarus, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Functional Outcomes of Bracing Treatment Using Dimeglio Scores (time frame: Collected when visit where cast is applied, visit when cast is removed, then at 2 weeks, 12 weeks, 24 weeks of bracing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.