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Clinical Trials/NCT05913934
NCT05913934
Active, not recruiting
Not Applicable

Control Gait Analysis in Clubfoot Children and Comparison With Their Healthy Twins

Dr.Joller BioMedical Consulting1 site in 1 country24 target enrollmentApril 29, 2023
ConditionsClubfoot

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Clubfoot
Sponsor
Dr.Joller BioMedical Consulting
Enrollment
24
Locations
1
Primary Endpoint
Differences in gait analyses of treated clubfeet and their healthy twin siblings: p-value
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
April 29, 2023
End Date
July 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dr.Joller BioMedical Consulting
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Twins with clubfeet

Exclusion Criteria

  • All other clubfeet

Outcomes

Primary Outcomes

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.

Study Sites (1)

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