An observational study in Clubfoot, sponsored by Dr.Joller BioMedical Consulting. Active, not recruiting at 1 site in Switzerland. Open to participants aged 3 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Dr.Joller BioMedical Consulting · Observational
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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.
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.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's enrollment of 24 is below the median of 55 across 27 observational studies indexed under Clubfoot.
Browse Clubfoot studies →This is the only study on the registry with Dr.Joller BioMedical Consulting as lead sponsor.
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Children from 3 to 14 years old, beeing treated for clubfeet and their healthy twins.
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Exclusion Criteria:
Twins: Gait analysis
Behavioral: Gait analysis
Walk over 25 meters in a gym (GaitUp) Walk over 6 meters with footscan v9 in the office
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.
Time frame: 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.
Time frame: 2 years
Plan to share: Yes
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Jul 2023, 2 months after the start.
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This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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