Barefoot RunningNCT04699019
Evaluating the Foot Touch Framework Model
An observational study of Barefoot Running, run by Orthocare Innovations, LLC at 1 site in United States.
Trial summary
A Foot Touch framework model has been developed to express the ground reaction force waveforms observed for walking and running. The purpose of this research is to collect ground reaction force data during walking and running that can be used to evaluate and verify the Foot Touch framework. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Barefoot Running
- What is being tested?
- Four speeds and Foot Strike Pattern
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 8 Jan 2021
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy, able-bodied participants will be recruited from the general public.
Who may be able to join
- Healthy adult men and women
- Capable of independently walking and running at various speeds for a minimum of 30 minutes
- No history of significant injuries in the past six months
- Ability to walk and run without shoes/footwear
- Ability to perform one- and two-footed hops up and down from 5 cm and 10 cm heights
- Ability to provide informed consent
Who cannot join
- Confounding chronic injury or musculoskeletal problem
- Pregnancy
- Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
- Not able to read and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthocare Innovations, LLC
Edmonds, Washington, 98020
About this study
Official title: Evaluating the Foot Touch Framework Model in Running
A Foot Touch framework model has been developed to express the ground reaction force waveforms observed for walking and running. The purpose of this research is to collect ground reaction force data during walking and running that can be used to evaluate and verify the Foot Touch framework.
- Conditions
- Barefoot Running
- Being tested
- Four speeds, Foot Strike Pattern
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four speedsOther
Four speeds ranging from a set walking speed up to 9 mph
Foot Strike PatternOther
Foot strike sequences (rearfoot strike, midfoot strike, forefoot strike)
| Study group | Role | What they receive |
|---|---|---|
| Active Runners | All participants will be required to run unshod for a combination of four prescribed speeds (walking and up to 9 mph) and three different foot strike patterns (rearfoot, midfoot, and forefoot) on level ground. Receives: Other: Four speeds; Other: Foot Strike Pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
MatScan Forces
Ground reaction forces for distinct anatomical regions of the foot (Calcaneal, Tarsal, Metatarsal, Phalangeal) measured by the MatScan system
Measured: Assessed on day 1 (data collection day)
Secondary outcomes (4)
Ground reaction force
Ground reaction force measured by the force plate during walking, running, and hopping tasks
Measured: Assessed on day 1 (data collection day)
Ankle joint angle
Ankle joint angle measured by motion analysis system during walking, running, and hopping tasks
Measured: Assessed on day 1 (data collection day)
Knee joint angle
Knee joint angle measured by motion analysis system during walking, running, and hopping tasks
Measured: Assessed on day 1 (data collection day)
Hip joint angle
Hip joint angle measured by motion analysis system during walking, running, and hopping tasks
Measured: Assessed on day 1 (data collection day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start7 Feb 2019
- Primary completion28 Jul 2019
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barefoot RunningStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthocare Innovations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FastEquation Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699019
- Sponsor's protocol ID
- 20190314
- Status last verified
- Sep 2021
- First submitted
- 22 Dec 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Foot Touch Framework Model in Running
- ClinicalTrials.gov ID
- NCT04699019
- Acronym / sponsor ID
- 20190314
- Conditions
- Barefoot Running
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Orthocare Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- FastEquation Inc.
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 28 Jul 2019 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 7 Jan 2021 (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.
A Foot Touch framework model has been developed to express the ground reaction force waveforms observed for walking and running. The purpose of this research is to collect ground reaction force data during walking and running that can be used to evaluate and verify the Foot Touch framework.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Runners | – | Other: Four speeds, Other: Foot Strike PatternAll participants will be required to run unshod for a combination of four prescribed speeds (walking and up to 9 mph) and three different foot strike patterns (rearfoot, midfoot, and forefoot) on level ground. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy, able-bodied participants will be recruited from the general public.
Key inclusion criteria (6 listed)
- Healthy adult men and women
- Capable of independently walking and running at various speeds for a minimum of 30 minutes
- No history of significant injuries in the past six months
- Ability to walk and run without shoes/footwear
- Ability to perform one- and two-footed hops up and down from 5 cm and 10 cm heights
Key exclusion criteria (4 listed)
- Confounding chronic injury or musculoskeletal problem
- Pregnancy
- Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
- Not able to read and understand English
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 |
|---|---|---|
| Four speedsFour speeds ranging from a set walking speed up to 9 mph | Other | Active Runners |
| Foot Strike PatternFoot strike sequences (rearfoot strike, midfoot strike, forefoot strike) | Other | Active Runners |
Primary outcome
MatScan Forces
Time frame: Assessed on day 1 (data collection day)
Ground reaction forces for distinct anatomical regions of the foot (Calcaneal, Tarsal, Metatarsal, Phalangeal) measured by the MatScan system
4 secondary outcomes
Ground reaction force
Time frame: Assessed on day 1 (data collection day)
Ankle joint angle
Time frame: Assessed on day 1 (data collection day)
Knee joint angle
Time frame: Assessed on day 1 (data collection day)
Hip joint angle
Time frame: Assessed on day 1 (data collection day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barefoot Running, run by Orthocare Innovations, LLC 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 8 Sep 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MatScan Forces (time frame: Assessed on day 1 (data collection day)). 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 8 Sep 2021.