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CompletedNCT01908998Updated Apr 20, 2015

Influence of Supportive Sandals on Y-Balance Performance on Healthy Young Individuals

An interventional study of Sandal in Y-balance Performance, sponsored by Temple University. Completed at 1 site in United States. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-20.

Sponsored by Temple University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
21 Years to 40 Years
Sex
All
01

Study 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. The investigators hypothesize that by improving alignment and augmenting muscle mechanics, sandals with medial arch support may improve Y-Balance scores.

02

Conditions studied

  • Y-balance Performance

Keywords

  • Y-Balance test
03

In context

Lead sponsor

Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Sandal

    Other: Sandal

Interventions

  • OtherSandal

    Subjectes will be scored on the Y-Balance Test wearing an Orthaheel Sandal

    Also known as: Orthaheel Sandal

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 1

Secondary outcomes

  1. Arch Height Index

    An instrumented measure of arch height will be taken

    Time frame: Day 1

Other outcomes

  1. Malleolar Valgus Index

    Malleolar valus testing will be performed to assess the structure of the hind foot

    Time frame: Day 1

  2. EMED-X

    An EMED-X device will be used to assess plantar pressure when walking

    Time frame: Day 1

  3. GaitMatII

    temporal and spatial foot fall parameters will be quantified with the GaitMatII.

    Time frame: Day 1

07

Study locations

1 site
  • Temple University School of Podiatric Medicine
    Philadelphia, Pennsylvania 19107, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01908998
Lead sponsor
Temple University
Responsible party
Sponsor
First posted
Jul 26, 2013
Start date
Jul 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Apr 20, 2015

Study contacts

Steven J Pettineo, DPT
principal investigator · Temple University
Jinsup Song, DPM
principal investigator · Temple University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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