NCT01908998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 20, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

July 17, 2013

Last Update Submit

April 17, 2015

Conditions

Y-balance Performance

Keywords

Y-Balance test

Outcome Measures

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

    Day 1

Secondary Outcomes (1)

  • Arch Height Index

    Day 1

Other Outcomes (3)

  • Malleolar Valgus Index

    Day 1

  • EMED-X

    Day 1

  • GaitMatII

    Day 1

Study Arms (1)

Sandal

ACTIVE COMPARATOR
Other: Sandal

Interventions

SandalOTHER

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

Also known as: Orthaheel Sandal
Sandal

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University School of Podiatric Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

sandal wood oil-turmeric cream

Study Officials

  • Steven J Pettineo, DPT

    Temple University

    PRINCIPAL INVESTIGATOR

  • Jinsup Song, DPM

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 26, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 20, 2015

Record last verified: 2015-04

Locations

US(1)