NCT00389662

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

October 18, 2006

Last Update Submit

December 19, 2007

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Isokinetic strength of foot and ankle muscles and on proprioception

    4 months after starting the data registration

Interventions

Wearing the "Nike Free" shoeDEVICE

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Philip Roosen, Physiotherapist

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2006

First Posted

October 19, 2006

Study Start

November 1, 2006

Study Completion

April 1, 2007

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

BE(1)