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.

Study Overview

• Status: Completed
• Conditions: Y-balance Performance
• Intervention / Treatment: Other: Sandal

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sandal	Other: Sandal; Subjectes will be scored on the Y-Balance Test wearing an Orthaheel Sandal; Other Names: Orthaheel Sandal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arch Height Index	An instrumented measure of arch height will be taken	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malleolar Valgus Index	Malleolar valus testing will be performed to assess the structure of the hind foot	Day 1
EMED-X	An EMED-X device will be used to assess plantar pressure when walking	Day 1
GaitMatII	temporal and spatial foot fall parameters will be quantified with the GaitMatII.	Day 1

Collaborators and Investigators

• Sponsor: Temple University
• Investigators: Principal Investigator: Steven J Pettineo, DPT, Temple University; Principal Investigator: Jinsup Song, DPM, Temple University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Estimate): April 20, 2015
• Last Update Submitted That Met QC Criteria: April 17, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Y-Balance test
• Other Study ID Numbers: 21460