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Completed

NCT Number: NCT01908998

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

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.

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Key information

Conditions

Y-balance Performance

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University School of Podiatric Medicine

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sandal

Other

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

Other names: Orthaheel Sandal

Primary outcomes

  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 outcomes

  1. Arch Height Index

    Time frame: Day 1

    An instrumented measure of arch height will be taken

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2013
Registry last updated
Apr 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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