Everyday Activity Shoes: a Quantification of Impact Forces While Walking

NCT04197362 | Terminated

• 1 other identifier: IRB00112113
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Impact Forces

Keywords

activity shoes; forces; torques; cartilage; bones

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Differences in torques at the bilateral anterior and posterior superior spine comparing three study arms

  One-time at enrollment, no follow-up

• Differences in forces at the bilateral anterior and posterior superior spine comparing three study arms

  One-time at enrollment, no follow-up

• Differences in torques at the lateral femoral condyles comparing three study arms

  One-time at enrollment, no follow-up

• Differences in forces at the lateral femoral condyles comparing three study arms

  One-time at enrollment, no follow-up

• Differences in torques at the lateral mid-shanks comparing three study arms

  One-time at enrollment, no follow-up

Study Arms (3)

ASICS Women's Gel-Venture 6 Running-Shoe

EXPERIMENTAL

ASICS Women's Gel-Venture 6 Running-Shoe

Other: Evaluation

Nike Air Max 270

EXPERIMENTAL

Nike Air Max 270

Other: Evaluation

La Vida+

EXPERIMENTAL

La Vida+

Other: Evaluation

Interventions

Evaluation OTHER

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.

ASICS Women's Gel-Venture 6 Running-Shoe; La Vida+; Nike Air Max 270

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Rehabilitation Hospital

Atlanta, Georgia, 30322, United States

Location

Study Officials

• David Burke, MD, MA

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The subjects will be fitted in random order of a pair of ASICS Women's Gel-Venture 6 Running-Shoe, Nike Air Max 270, La Vida+ athletic shoes. Subjects will be pre-assigned randomly to start and continue with specific shoe groups, ultimately exhausting all options.

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: October 19, 2023
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)