Impact ForcesNCT04197362
Everyday Activity Shoes: a Quantification of Impact Forces While Walking
A study testing Evaluation in people with Impact Forces, run by Emory University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Impact Forces
- What is being tested?
- Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2023to 13 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Rehabilitation Hospital
Atlanta, Georgia, 30322
About this study
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).
Read the 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).
- Conditions
- Impact Forces
- Being tested
- Evaluation
- Keywords
- activity shoes, forces, torques, cartilage, bones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ASICS Women's Gel-Venture 6 Running-Shoe | Experimental | ASICS Women's Gel-Venture 6 Running-Shoe Receives: Other: Evaluation |
| Nike Air Max 270 | Experimental | Nike Air Max 270 Receives: Other: Evaluation |
| La Vida+ | Experimental | La Vida+ Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One-time at enrollment, no follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start19 Oct 2023
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Why it stopped: The study was terminated due to the PI leaving for sabbatical.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact ForcesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David T. Burke, Emory University
- Investigators
- David Burke, MD, MA, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197362
- Sponsor's protocol ID
- IRB00112113
- Status last verified
- May 2024
- First submitted
- 11 Dec 2019
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everyday Activity Shoes: a Quantification of Impact Forces While Walking
- ClinicalTrials.gov ID
- NCT04197362
- Acronym / sponsor ID
- IRB00112113
- Conditions
- Impact Forces
- Keywords
- activity shoes, forces, torques, cartilage, bones
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to the PI leaving for sabbatical.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| ASICS Women's Gel-Venture 6 Running-Shoe | Experimental | Other: EvaluationASICS Women's Gel-Venture 6 Running-Shoe |
| Nike Air Max 270 | Experimental | Other: EvaluationNike Air Max 270 |
| La Vida+ | Experimental | Other: EvaluationLa Vida+ |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvaluationSubjects 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. | Other | ASICS Women's Gel-Venture 6 Running-Shoe, La Vida+, Nike Air Max 270 |
Primary outcome
Differences in torques at the knee comparing three study arms
Time frame: 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
Time frame: 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.
12 secondary outcomes
Differences in torques at the bilateral anterior and posterior superior spine comparing three study arms
Time frame: One-time at enrollment, no follow-up
Differences in forces at the bilateral anterior and posterior superior spine comparing three study arms
Time frame: One-time at enrollment, no follow-up
Differences in torques at the lateral femoral condyles comparing three study arms
Time frame: One-time at enrollment, no follow-up
Differences in forces at the lateral femoral condyles comparing three study arms
Time frame: One-time at enrollment, no follow-up
Differences in torques at the lateral mid-shanks comparing three study arms
Time frame: One-time at enrollment, no follow-up
Differences in forces at the lateral mid-shanks comparing three study arms
Time frame: One-time at enrollment, no follow-up day
Differences in torques at the lateral malleoli comparing three study arms
Time frame: One-time at enrollment, no follow-up
Differences in forces at the lateral malleoli comparing three study arms
Time frame: One-time at enrollment, no follow-up
Differences in torques at the second metatarsal heads comparing three study arms
Time frame: One-time at enrollment, no follow-up
Differences in forces at the second metatarsal heads comparing three study arms
Time frame: One-time at enrollment, no follow-up
Differences in torques at the heels comparing three study arms
Time frame: One-time at enrollment, no follow-up
Differences in forces at the heels comparing three study arms
Time frame: One-time at enrollment, no follow-up
Results and safety
The study was stopped early (reason given: The study was terminated due to the PI leaving for sabbatical.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Burke, MD, MA principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation in people with Impact Forces, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to the PI leaving for sabbatical.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in torques at the knee comparing three study arms (time frame: One-time at enrollment, no follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.