Y-balance PerformanceNCT01908998
Influence of Supportive Sandals on Y-Balance Performance on Healthy Young Individuals
A study testing Sandal in people with Y-balance Performance, run by Temple University at 1 site in United States.
Trial summary
The Y-balance test is a lower extremity, dynamic test performed in single limb stance that measures a person's ability to reach in 3 directions. The test is typically conducted in barefoot. The purpose of this study is to assess the impact of footwear on Y-Balance test scores. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Y-balance Performance
- What is being tested?
- Sandal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2014
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or Women between the ages of 21 to 40 years, inclusive
- Grossly intact and symmetrical neuromuscular status
- Able to ambulate without difficult or pain
- Able to understand the information in the informed consent form
- willing and able to sign informed consent form
Who cannot join
- history of ankle sprain, Anterior cruciate ligament injury; recent hip, knee, foot or ankle pain within past 6 months
- Uncontrolled Heart (Hypertension; BP >= 140/90), Lung Disease (uncontrolled asthma or shortness of breath), or diabetes
- Nursing or pregnant
- Not willing or able to follow procedures specified by protocol and/or instructions of the study personnel
- Unable to fit into available shoe sizes
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
About this study
The Y-balance test is a lower extremity, dynamic test performed in single limb stance that measures a person's ability to reach in 3 directions. The test is typically conducted in barefoot. The purpose of this study is to assess the impact of footwear on Y-Balance test scores. The investigators hypothesize that by improving alignment and augmenting muscle mechanics, sandals with medial arch support may improve Y-Balance scores.
- Conditions
- Y-balance Performance
- Being tested
- Sandal
- Keywords
- Y-Balance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SandalOther
Also called Orthaheel Sandal
Subjectes will be scored on the Y-Balance Test wearing an Orthaheel Sandal
| Study group | Role | What they receive |
|---|---|---|
| Sandal | Active comparator | Not described Receives: Other: Sandal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y-Balance Test Score
Anterior, Posterior-medial and posterior-lateral maximum displacement (in cm) will be recorded as the best of three trials for each supportive limb in barefoot, supportive sandal and flip-flop
Measured: Day 1
Secondary outcomes (1)
Arch Height Index
An instrumented measure of arch height will be taken
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Y-balance PerformanceStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven J Pettineo, DPT, Principal investigator, Temple UniversityJinsup Song, DPM, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908998
- Sponsor's protocol ID
- 21460
- Status last verified
- Apr 2015
- First submitted
- 17 Jul 2013
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Supportive Sandals on Y-Balance Performance on Healthy Young Individuals
- ClinicalTrials.gov ID
- NCT01908998
- Acronym / sponsor ID
- 21460
- Conditions
- Y-balance Performance
- Keywords
- Y-Balance test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Jul 2013 (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.
The Y-balance test is a lower extremity, dynamic test performed in single limb stance that measures a person's ability to reach in 3 directions. The test is typically conducted in barefoot. The purpose of this study is to assess the impact of footwear on Y-Balance test scores. The investigators hypothesize that by improving alignment and augmenting muscle mechanics, sandals with medial arch support may improve Y-Balance scores.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sandal | Active comparator | Other: Sandal |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men or Women between the ages of 21 to 40 years, inclusive
- Grossly intact and symmetrical neuromuscular status
- Able to ambulate without difficult or pain
- Able to understand the information in the informed consent form
- willing and able to sign informed consent form
Key exclusion criteria (5 listed)
- history of ankle sprain, Anterior cruciate ligament injury; recent hip, knee, foot or ankle pain within past 6 months
- Uncontrolled Heart (Hypertension; BP >= 140/90), Lung Disease (uncontrolled asthma or shortness of breath), or diabetes
- Nursing or pregnant
- Not willing or able to follow procedures specified by protocol and/or instructions of the study personnel
- Unable to fit into available shoe sizes
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 |
|---|---|---|
| SandalAlso: Orthaheel SandalSubjectes will be scored on the Y-Balance Test wearing an Orthaheel Sandal | Other | Sandal |
Primary outcome
Y-Balance Test Score
Time frame: Day 1
Anterior, Posterior-medial and posterior-lateral maximum displacement (in cm) will be recorded as the best of three trials for each supportive limb in barefoot, supportive sandal and flip-flop
1 secondary outcome
Arch Height Index
Time frame: Day 1
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 20 Apr 2015.
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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.
Steven J Pettineo, DPT principal investigator
Temple University
Jinsup Song, DPM principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sandal in people with Y-balance Performance, run by Temple University at 1 site in United States.
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 5 inclusion and 5 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 20 Apr 2015. 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 United States. 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?
Y-Balance Test Score (time frame: Day 1). 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 20 Apr 2015.