HealthyNCT00389662
The Effect of Wearing the 'Nike Free'Shoe on Isokinetic Muscle Strength of Foot and Ankle and on Proprioception.
A study testing Wearing the "Nike Free" shoe in people with Healthy, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Wearing the "Nike Free" shoe
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2006to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Healthy
- Being tested
- Wearing the "Nike Free" shoe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing the "Nike Free" shoeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic strength of foot and ankle muscles and on proprioception
Measured: 4 months after starting the data registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startNov 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Nike
- Investigators
- Philip Roosen, Physiotherapist, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389662
- Sponsor's protocol ID
- 2006/345
- Status last verified
- Dec 2007
- First submitted
- 18 Oct 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wearing the 'Nike Free'Shoe on Isokinetic Muscle Strength of Foot and Ankle and on Proprioception.
- ClinicalTrials.gov ID
- NCT00389662
- Acronym / sponsor ID
- 2006/345
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Nike
- Study start
- Nov 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 19 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing the "Nike Free" shoe | Device | – |
Primary outcome
Isokinetic strength of foot and ankle muscles and on proprioception
Time frame: 4 months after starting the data registration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
- Website University GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Roosen, Physiotherapist principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing the "Nike Free" shoe in people with Healthy, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic strength of foot and ankle muscles and on proprioception (time frame: 4 months after starting the data registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2007.