Clubfeet and Twins and Gait Analysis

Sponsor

Dr.Joller BioMedical Consulting (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05913934

Collaborator

(none)

Enrollment

Location

3.1

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clubfoot	Behavioral: Gait analysis

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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

24 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Apr 29, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Gait analysis parameters Twins: Gait analysis	Behavioral: Gait analysis Walk over 25 meters in a gym (GaitUp) Walk over 6 meters with footscan v9 in the office

Arm

Intervention/Treatment

Gait analysis parameters

Twins: Gait analysis

Behavioral: Gait analysis

Walk over 25 meters in a gym (GaitUp) Walk over 6 meters with footscan v9 in the office

Outcome Measures

Primary Outcome Measures

Differences in gait analyses of treated clubfeet and their healthy twin siblings: p-value [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 [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.