Everyday Activity Shoes: a Quantification of Impact Forces While Walking

Impact Forces Clinical Trial

Official title:

Everyday Activity Shoes: a Quantification of Impact Forces While Walking

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04197362
• Other study ID #: IRB00112113
• Status: Terminated
• Phase: N/A
• Start date: October 19, 2023
• Est. completion date: December 13, 2023

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Impact Forces

Intervention

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.

Locations

Country	Name	City	State
United States	Emory Rehabilitation Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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