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NCT00389662 Clinical Trial

The Effect of Wearing the 'Nike Free'Shoe on Isokinetic Muscle Strength of Foot and Ankle and on Proprioception.

Healthy Clinical Trial

Official title:
The Effect of Wearing the 'Nike Free'Shoe on Isokinetic Muscle Strength of Foot and Ankle and on Proprioception.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00389662
Other study ID # 2006/345
Secondary ID
Status Completed
Phase N/A
First received October 18, 2006
Last updated December 19, 2007
Start date November 2006
Est. completion date April 2007

Study information
Verified date December 2007
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To evaluate the effect of wearing the 'Nike Free'Shoe on isokinetic muscle strength of foot and ankle and on proprioception the following protocol will be used.

The test population consists out of students of the physical education department. They will at random be divided in three groups. One group will wear the shoe only for daily activities, the second group will wear the shoes for the warming up part of the sport classes and the control group will not wear the shoe at all. There will be two moments for evaluation: one at the beginning of the study and one after four months, during which the shoe will be used. The isokinetic strength will be measured with an isokinetic device (Biodex) and the proprioception will be evaluated with a force platform (Neurocom Balance Master).

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- being a physical education student of the second or third year

- having read and signed the informed consent

- being new to the Nike Free Shoe

Exclusion Criteria:

- neurological or systemic diseases

- overuse injuries or orthopaedic surgery to the lower limbs during the previous six months

- familiar to or used to wear the Nike Free Shoe

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Wearing the "Nike Free" shoe

Locations
Country Name City State
Belgium University Ghent Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Ghent Nike

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Isokinetic strength of foot and ankle muscles and on proprioception 4 months after starting the data registration
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