Clubfeet and Twins and Gait Analysis

NCT05913934 | Unknown

• 1 other identifier: ID 2023-00290
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Clubfoot

Keywords

Clubfoot; gait analysis; twin comparison; inertial sensor; footscan; manual-dynamic physiotherapy; derotation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Gait analysis parameters

Twins: Gait analysis

Behavioral: Gait analysis

Interventions

Gait analysis BEHAVIORAL

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

Gait analysis parameters

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Twins with clubfeet

You may not qualify if:

• All other clubfeet

Sponsors & Collaborators

• Dr.Joller BioMedical Consulting: lead

Study Sites (1)

Dr.Joller BioMedical Consulting

Zurich, 8057, Switzerland

Location

MeSH Terms

Conditions

Clubfoot

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Peter Joller, PhD

  Dr.Joller BioMedical Consulting

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 22, 2023
• Study Start: April 29, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 31, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)