Clubfeet and Twins and Gait Analysis

Clubfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05913934
• Other study ID #: ID 2023-00290
• Status: Active, not recruiting
• Start date: April 29, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: June 2023
• Source: Dr.Joller BioMedical Consulting
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Nonparametric statistics are applied to verify aberrations.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: July 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

Inclusion Criteria:

• Twins with clubfeet

Exclusion Criteria:

• All other clubfeet

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity
• Foot Deformities

Intervention

Behavioral:
• Gait analysis
Walk over 25 meters in a gym (GaitUp) Walk over 6 meters with footscan v9 in the office

Locations

Country	Name	City	State
Switzerland	Dr.Joller BioMedical Consulting	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Dr.Joller BioMedical Consulting

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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.	2 years