ClubfootNCT05913934
Clubfeet and Twins and Gait Analysis
An observational study of Clubfoot, run by Dr.Joller BioMedical Consulting at 1 site in Switzerland.
Trial summary
Children with clubfeet who were exclusively treated by Ursula Issler-Wüthrich for 3 to 14 years with manual-dynamic physiotherapy and their healthy twin siblings are compared using gait analysis. GaitUp sensors (kinematic) and footscan V9 (kinetic) are the systems used for this comparison. Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Clubfoot
- What is being tested?
- Gait analysis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Apr 2023to 31 Jul 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children from 3 to 14 years old, beeing treated for clubfeet and their healthy twins.
Who may be able to join
- Twins with clubfeet
Who cannot join
- All other clubfeet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Control Gait Analysis in Clubfoot Children and Comparison With Their Healthy Twins
Children with clubfeet who were exclusively treated by Ursula Issler-Wüthrich for 3 to 14 years with manual-dynamic physiotherapy and their healthy twin siblings are compared using gait analysis.
GaitUp sensors (kinematic) and footscan V9 (kinetic) are the systems used for this comparison.
Nonparametric statistics are applied to verify aberrations.
Read the detailed description
Control gait analysis in clubfoot children and comparison with their healthy twins
Clubfeet are the most common birth defect with about 80 cases in Switzerland per year. There are two important therapies: Ponseti and manual-dynamic physiotherapy.
Ursula Issler-Wüthrich, physiotherapist, since twenty years treats exclusively clubfeet and comorbidities with clubfeet like arthrogryposis and myelomeningocele. Until today she corrected more than 400 feet with manual-dynamic physiotherapy.
Among her patients there are 11 twin pairs. In the scientific literature it is stated that in unilateral clubfoot, the other foot cannot be considered normal.With the two gait analysis systems meant for controlling the therapy results, the walking pattern of the healthy twin was compared with the pattern of the affected twin sibling.
The basis of the study is a walk over 25 meters with the GaitUp sensors (11 g) resulting in 22 quantitative digital parameters and tests on the pedobarographic plate footscan V9 leading to 10 parameters.
Statistically it will be analyzed whether there is a discrepancy between the clubfeet children and their healthy twins.
The parents in writing and the children orally gladly approved the task.
- Conditions
- Clubfoot
- Being tested
- Gait analysis
- Keywords
- Clubfoot, gait analysis, twin comparison, inertial sensor, footscan, manual-dynamic physiotherapy, derotation
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisBehavioural
Walk over 25 meters in a gym (GaitUp) Walk over 6 meters with footscan v9 in the office
| Study group | Role | What they receive |
|---|---|---|
| Gait analysis parameters | Twins: Gait analysis Receives: Behavioral: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in gait analyses of treated clubfeet and their healthy twin siblings: p-value
The gait analyses parameters are statistically compared between the healhy siblings and the clubfoot twins. The p-values descibe the disparity among the groups. p-values below 0.05 point to a statistical difference and are a clue to insufficient therapy.
Measured: 2 years
Differences in gait analyses of treated clubfeet and their healthy twin siblings:Effect size
The effect size is a measure for the interpretation of differences. It represents the shift between the standard curves of the two populations. Effect sizes of more than ±0.5 suggests a serious discrepancy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start29 Apr 2023
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Dr.Joller BioMedical Consulting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Joller, PhD, Study director, Dr.Joller BioMedical Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913934
- Sponsor's protocol ID
- ID 2023-00290
- Status last verified
- Jun 2023
- First submitted
- 19 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control Gait Analysis in Clubfoot Children and Comparison With Their Healthy Twins
- ClinicalTrials.gov ID
- NCT05913934
- Acronym / sponsor ID
- ID 2023-00290
- Conditions
- Clubfoot
- Keywords
- Clubfoot, gait analysis, twin comparison, inertial sensor, footscan, manual-dynamic physiotherapy, derotation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dr.Joller BioMedical ConsultingUniversity, hospital or other
- Study start
- 29 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 22 Jun 2023 (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.
Children with clubfeet who were exclusively treated by Ursula Issler-Wüthrich for 3 to 14 years with manual-dynamic physiotherapy and their healthy twin siblings are compared using gait analysis.
GaitUp sensors (kinematic) and footscan V9 (kinetic) are the systems used for this comparison.
Nonparametric statistics are applied to verify aberrations.
Detailed description
Control gait analysis in clubfoot children and comparison with their healthy twins
Clubfeet are the most common birth defect with about 80 cases in Switzerland per year. There are two important therapies: Ponseti and manual-dynamic physiotherapy.
Ursula Issler-Wüthrich, physiotherapist, since twenty years treats exclusively clubfeet and comorbidities with clubfeet like arthrogryposis and myelomeningocele. Until today she corrected more than 400 feet with manual-dynamic physiotherapy.
Among her patients there are 11 twin pairs. In the scientific literature it is stated that in unilateral clubfoot, the other foot cannot be considered normal.With the two gait analysis systems meant for controlling the therapy results, the walking pattern of the healthy twin was compared with the pattern of the affected twin sibling.
The basis of the study is a walk over 25 meters with the GaitUp sensors (11 g) resulting in 22 quantitative digital parameters and tests on the pedobarographic plate footscan V9 leading to 10 parameters.
Statistically it will be analyzed whether there is a discrepancy between the clubfeet children and their healthy twins.
The parents in writing and the children orally gladly approved the task.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait analysis parameters | – | Behavioral: Gait analysisTwins: Gait analysis |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children from 3 to 14 years old, beeing treated for clubfeet and their healthy twins.
Key inclusion criteria (1 listed)
- Twins with clubfeet
Key exclusion criteria (1 listed)
- All other clubfeet
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 |
|---|---|---|
| Gait analysisWalk over 25 meters in a gym (GaitUp) Walk over 6 meters with footscan v9 in the office | Behavioural | Gait analysis parameters |
Primary outcome
Differences in gait analyses of treated clubfeet and their healthy twin siblings: p-value
Time frame: 2 years
The gait analyses parameters are statistically compared between the healhy siblings and the clubfoot twins. The p-values descibe the disparity among the groups. p-values below 0.05 point to a statistical difference and are a clue to insufficient therapy.
Differences in gait analyses of treated clubfeet and their healthy twin siblings:Effect size
Time frame: 2 years
The effect size is a measure for the interpretation of differences. It represents the shift between the standard curves of the two populations. Effect sizes of more than ±0.5 suggests a serious discrepancy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes
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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.
Peter Joller, PhD study director
Dr.Joller BioMedical Consulting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot, run by Dr.Joller BioMedical Consulting at 1 site in Switzerland.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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 Switzerland. 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?
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?
Differences in gait analyses of treated clubfeet and their healthy twin siblings: p-value (time frame: 2 years). The study lists 2 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 22 Jun 2023.