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

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ClinicalTrials.gov Identifier: NCT01908998
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : April 20, 2015
Sponsor:
Information provided by (Responsible Party):
Temple University

Brief 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.

Condition or disease Intervention/treatment Phase
Y-balance Performance Other: Sandal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Influence of Supportive Sandals on Y-Balance Performance on Healthy Young Individuals
Study Start Date : July 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Active Comparator: Sandal Other: Sandal
Subjectes will be scored on the Y-Balance Test wearing an Orthaheel Sandal
Other Name: Orthaheel Sandal




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Arch Height Index [ Time Frame: Day 1 ]
    An instrumented measure of arch height will be taken


Other Outcome Measures:
  1. Malleolar Valgus Index [ Time Frame: Day 1 ]
    Malleolar valus testing will be performed to assess the structure of the hind foot

  2. EMED-X [ Time Frame: Day 1 ]
    An EMED-X device will be used to assess plantar pressure when walking

  3. GaitMatII [ Time Frame: Day 1 ]
    temporal and spatial foot fall parameters will be quantified with the GaitMatII.



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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908998


Locations
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United States, Pennsylvania
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Temple University
Investigators
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Principal Investigator: Steven J Pettineo, DPT Temple University
Principal Investigator: Jinsup Song, DPM Temple University

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01908998     History of Changes
Other Study ID Numbers: 21460
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: April 20, 2015
Last Verified: April 2015
Keywords provided by Temple University:
Y-Balance test