Everyday Activity Shoes: a Quantification of Impact Forces While Walking

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: Recruiting
• Conditions: Impact Forces
• Intervention / Treatment: Other: Evaluation

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: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Burke, MD, MA; Phone Number: 404-712-1899; Email: dburke2@emory.edu
• Study Contact Backup: Name: Gina Bell, MPH; Phone Number: 404-712-1899; Email: burke.research@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory Rehabilitation Hospital
      • Contact: David Burke, MD, MA; Phone Number: 404-712-5507; Email: DBURKE2@emory.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Differences in torques at the knee comparing three study arms	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	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

Outcome Measure	Measure Description	Time Frame
Differences in torques at the bilateral anterior and posterior superior spine comparing three study arms	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Emory University
• Investigators: Principal Investigator: David Burke, MD, MA, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: cartilage; bones; activity shoes; forces; torques
• Other Study ID 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