The Effect of Wearing the 'Nike Free'Shoe on Isokinetic M... | NCT00389662

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

NCT00389662

Sponsor

University Ghent

Status

Completed

Last Update Posted

Dec 28, 2007Estimated

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

Wearing the "Nike Free" shoe

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Oct 18, 2006

First Submission Date that Met QC Criteria

Oct 18, 2006

First Posted Date

Oct 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2007

Last Update Posted Date

Dec 28, 2007Estimated

Name	Class
Nike	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Name	Type	Description	Arm Group Labels	Other Names
Wearing the "Nike Free" shoe	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Isokinetic strength of foot and ankle muscles and on proprioception		4 months after starting the data registration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Roosen, Physiotherapist	University Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Ghent		Ghent		9000	Belgium