- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296913
Studying the Effects of the X10D Shoe on Walking in Healthy Adults Aged 50 to 65
Characterizing the Effects of the X10D Sole on Walking Behavior in Healthy Subjects
The aim of this study is to characterize the biomechanical effects of the X10D sole using objective, quantitative measurement methods.
The walking pattern of many people is becoming increasingly passive, and the muscles of the feet and legs are getting weaker. The X10D shoe is an adapted shoe designed to make walking more active and dynamic again.
This study investigates the detailed biomechanical effects of the X10D shoe on the walking pattern of healthy participants. For this purpose, walking with the X10D shoe will be compared with (1) walking in a control shoe with a neutral sole and (2) walking in the participants' everyday sports shoes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Canton of Zurich
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Zurich, Canton of Zurich, Switzerland, 8008
- Balgrist Campus AG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The inclusion criteria are:
- Healthy subjects aged 50-65 years
- Ability to walk at minimum 30 minutes at a regular pace without assistance or breaks
- Written informed consent as documented by signature (see informed consent form)
Exclusion Criteria:The exclusion criteria are:
- Women who are pregnant or breast feeding
- Current neurological problems affecting walking function and balance
- Current orthopedic problems affecting upper and lower extremity movements
- History of alcohol abuse or the intake of psychotropic drugs
- History of major cardiac condition (e.g., infarction, insufficiency (NYHA II-IV))
- History of major pulmonary condition (e.g., chronic obstructive pulmonary disease (GOLD II-IV))
- Current major depression or psychosis
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
- Fever of unknown origin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional shoe
|
In this study, we assess the immediate and long-lasting (3-4 weeks) effects of the X10D shoe on a comprehensive battery of biomechanical parameters during various forms of walking.
This will be the first study to provide a detailed characterization of the effects of the X10D shoe on diverse walking parameters in healthy individuals aged 50 to 65 years.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
CoP path during ankle-foot roll-over movement as measured by pressure plates integrated in the treadmill
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-00477
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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