Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-29 @ 12:11 AM
Study NCT ID:
NCT05913934
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clubfeet and Twins and Gait Analysis
Sponsor:
Dr.Joller BioMedical Consulting
Organization:
Study Overview
Official Title:
Control Gait Analysis in Clubfoot Children and Comparison With Their Healthy Twins
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: