Clinical trial NCT04197362: Everyday Activity Shoes: a Quantification of Impact Forces While Walking
Official title: Everyday Activity Shoes: a Quantification of Impact Forces While Walking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Impact Forces
Keywords: activity shoes
forces
torques
cartilage
bones
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Differences in torques at the knee comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in forces at the knee comparing three study arms
timeFrame: One-time at enrollment, no follow-up
Secondary outcomes:
measure: Differences in torques at the bilateral anterior and posterior superior spine comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in forces at the bilateral anterior and posterior superior spine comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in torques at the lateral femoral condyles comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in forces at the lateral femoral condyles comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in torques at the lateral mid-shanks comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in forces at the lateral mid-shanks comparing three study arms
timeFrame: One-time at enrollment, no follow-up day
measure: Differences in torques at the lateral malleoli comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in forces at the lateral malleoli comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in torques at the second metatarsal heads comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in forces at the second metatarsal heads comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in torques at the heels comparing three study arms
timeFrame: One-time at enrollment, no follow-up
measure: Differences in forces at the heels comparing three study arms
timeFrame: One-time at enrollment, no follow-up
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Rehabilitation Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: David Burke, MD, MA
role: PRINCIPAL_INVESTIGATOR
References: