Everyday Activity Shoes: a Quantification of Impact Forces While Walking

Not Applicable

Terminated

• Conditions: Impact Forces
• Interventions: Other: Evaluation

• Registration Number: NCT04197362
• Lead Sponsor: Emory University

Brief Summary

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).

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Study Start: 2023-10-19
• Primary Completion: 2023-12-13
• Study Completion: 2023-12-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
La Vida+	Evaluation	La Vida+
Nike Air Max 270	Evaluation	Nike Air Max 270
ASICS Women's Gel-Venture 6 Running-Shoe	Evaluation	ASICS Women's Gel-Venture 6 Running-Shoe

Primary Outcome Measures

Name	Time	Method
Differences in torques at the knee comparing three study arms	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.
Differences in forces at the knee comparing three study arms	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.

Secondary Outcome Measures

Name	Time	Method
Differences in forces at the bilateral anterior and posterior superior spine comparing three study arms	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.
Differences in torques at the bilateral anterior and posterior superior spine comparing three study arms	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.
Differences in torques at the lateral femoral condyles comparing three study arms	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.
Differences in forces at the lateral femoral condyles comparing three study arms	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.
Differences in torques at the lateral mid-shanks comparing three study arms	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.
Differences in forces at the lateral mid-shanks comparing three study arms	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.
Differences in torques at the lateral malleoli comparing three study arms	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.
Differences in forces at the lateral malleoli comparing three study arms	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.
Differences in torques at the second metatarsal heads comparing three study arms	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.
Differences in forces at the second metatarsal heads comparing three study arms	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.
Differences in torques at the heels comparing three study arms	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.
Differences in forces at the heels comparing three study arms	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.

Trial Locations

Locations (1)

Emory Rehabilitation Hospital; 🇺🇸 Atlanta, Georgia, United States