Influence of Supportive Sandals on Y-Balance Performance... | NCT01908998

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

NCT01908998

Sponsor

Temple University

Status

Completed

Last Update Posted

Apr 20, 2015Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Y-balance Performance

Interventions

Sandal

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jul 17, 2013

First Submission Date that Met QC Criteria

Jul 23, 2013

First Posted Date

Jul 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2015

Last Update Posted Date

Apr 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sandal	Active Comparator		Other: Sandal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sandal	Other	Subjectes will be scored on the Y-Balance Test wearing an Orthaheel Sandal	Sandal

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven J Pettineo, DPT	Temple University	Principal Investigator
Jinsup Song, DPM	Temple University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Temple University School of Podiatric Medicine		Philadelphia	Pennsylvania	19107	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000593328	sandal wood oil-turmeric cream

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided