Everyday Activity Shoes: a Quantification of Impact Forces While Walking

May 7, 2024 updated by: David T. Burke, Emory University
This study aims to directly compare traditional everyday activity shoes (ASICS, Nike) with a shoe created to be flatter, less cushioned, and with less cradling of the foot (OESH shoe).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study addresses a common question in popular media: what attributes of traditional everyday activity shoes (Nike, New Balance, etc.) make a shoe better or worse. There have been several peer-reviewed studies aimed to answer this by calculating forces and torques at the ankles, knees, and hips while subjects wore shoes with different properties. Such characteristics include heel size, cushioning and side-to-side cradling of the foot. Interestingly, most studies have shown that the lack of a heel, less cushioning, and less cradling of the foot actually improve the biomechanics related to forces and torques, thus decreasing wear and tear on the cartilage and bones of the leg. Wear and tear on cartilage and bone may predispose patients to a bone condition called "osteoarthritis", which is a disease where bones become damaged from rubbing on each other with breakdown of a cartilage "cushion". This study thus aims to directly compare traditional everyday activity shoes (ASICS, Nike) with a shoe created to be flatter, less cushioned, and with less cradling of the foot (OESH shoe).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women between the ages of 18-65
  • Women who identify as "healthy"
  • Women who run or walk for exercise more than three times per week
  • Women in the Atlanta, Georgia area

Exclusion Criteria:

  • Individuals with history of significant musculoskeletal pathology
  • Individuals with musculoskeletal injury at time of testing
  • Individuals unable to consent
  • Individuals outside of the ages 18-65
  • Individuals who are prisoners
  • Individuals who do not speak or write in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ASICS Women's Gel-Venture 6 Running-Shoe
Other: Evaluation
Subjects will be asked to walk across the gait laboratory floor at their self-selected walking speed. They will complete a 3-5 minute warm up period, as it was found to produce stable estimates of kinetic parameter mean values during treadmill activity. The positions of each marker will be recorded through the motion capture system. Ground reaction force will be obtained in real time from the gait laboratory force plates as marker dimensions are recorded. For walking data, two trials of 15 seconds each will be recorded. The second trial will be a redundancy in the setting of potential significant marker dropout.
Experimental: Nike Air Max 270
Other: Evaluation
Subjects will be asked to walk across the gait laboratory floor at their self-selected walking speed. They will complete a 3-5 minute warm up period, as it was found to produce stable estimates of kinetic parameter mean values during treadmill activity. The positions of each marker will be recorded through the motion capture system. Ground reaction force will be obtained in real time from the gait laboratory force plates as marker dimensions are recorded. For walking data, two trials of 15 seconds each will be recorded. The second trial will be a redundancy in the setting of potential significant marker dropout.
Experimental: La Vida+
Other: Evaluation
Subjects will be asked to walk across the gait laboratory floor at their self-selected walking speed. They will complete a 3-5 minute warm up period, as it was found to produce stable estimates of kinetic parameter mean values during treadmill activity. The positions of each marker will be recorded through the motion capture system. Ground reaction force will be obtained in real time from the gait laboratory force plates as marker dimensions are recorded. For walking data, two trials of 15 seconds each will be recorded. The second trial will be a redundancy in the setting of potential significant marker dropout.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Differences in torques at the knee comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in forces at the knee comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in torques at the bilateral anterior and posterior superior spine comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in forces at the bilateral anterior and posterior superior spine comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in torques at the lateral femoral condyles comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in forces at the lateral femoral condyles comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in torques at the lateral mid-shanks comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in forces at the lateral mid-shanks comparing three study arms
Time Frame: One-time at enrollment, no follow-up day
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up day
Differences in torques at the lateral malleoli comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in forces at the lateral malleoli comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in torques at the second metatarsal heads comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in forces at the second metatarsal heads comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in torques at the heels comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up
Differences in forces at the heels comparing three study arms
Time Frame: One-time at enrollment, no follow-up
Joint torques and forces will be assessed via 16 markers placed on specified anatomical landmarks of the pelvis and lower extremities as the subjects walk across the gait floor at a self-selected speed. In analysis, joint torques and forces will be calculated through full inverse-dynamic model implementation using the Vicon Plug-In Gait. Differences in torques and peak forces will be calculated by ANOVA along with 95% confidence intervals.
One-time at enrollment, no follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Burke, MD, MA, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00112113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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