Clubfeet and Twins and Gait Analysis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Clubfoot
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8057
    • Dr.Joller BioMedical Consulting

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children from 3 to 14 years old, beeing treated for clubfeet and their healthy twins.

Description

Inclusion Criteria:

• Twins with clubfeet

Exclusion Criteria:

• All other clubfeet

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Dr.Joller BioMedical Consulting
• Investigators: Study Director: Peter Joller, PhD, Dr.Joller BioMedical Consulting

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2023
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): July 31, 2023

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: gait analysis; derotation; Clubfoot; twin comparison; inertial sensor; footscan; manual-dynamic physiotherapy
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity; Foot Deformities
• Other Study ID Numbers: ID 2023-00290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No