Healthy VolunteersFeetMe-GRFNCT06027762
Assessment of vGRF Measurement During Walking With Feetme® Insoles in Healthy Adults
An observational study of Healthy Volunteers, run by FeetMe at 1 site in France.
Trial summary
The objective of the present study is to demonstrate the validity and reliability of vGRF and other gait parameters measurement in healthy adults while walking with FeetMe® insoles compared to force plates (AMTI BP400600) and video motion capture system (Vicon NEXUS and MX-T40) . Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 30 Nov 2022
- How long will I take part?
- 1 Day
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Adults between 18 and 85 years old without gait pathologies
Who may be able to join
- Volunteers with following criteria satisfied:
- Between the ages of 18 and 80.
- Shoe size between 35 to 46.
- Body weight from 40kg to 120kg.
- Able to walk for 30 mins without assistance.
- Comfortable with using a smartphone.
Show all 15Show fewer
- Non-inclusion Criteria.
- A volunteer will not be included if one of the following conditions is met:
- cognitive or behavioral problems limiting communication or participation in the study
- deprivation of liberty by a legal or administrative decision
- adults subject to a legal protection measure or unable to express their consent
- pregnant, parturient and nursing mothers
- people admitted to a health or social establishment for purposes other than research
- Past or planned surgery with the possibility of impacting walking in the past 3 months or which had an impact on walking: orthopedic surgery, trauma to the lower limbs and spine, urological or gynecological surgery, brain and spinal cord surgery .
- Chronic disease affecting walking: Rheumatological, orthopedic, painful, neurological pathology.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Vertical Ground Reaction Force Measurement During Walking With Feetme® Insoles in Healthy Adults
The objective of the present study is to demonstrate the validity and reliability of vGRF and other gait parameters measurement in healthy adults while walking with FeetMe® insoles compared to force plates (AMTI BP400600) and video motion capture system (Vicon NEXUS and MX-T40) .
- Conditions
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single-Groupe | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
precision of measurement of 'maximum weight acceptance' and 'push-off' peaks in healthy adults by FeetMe® insoles
The primary objective of this clinical trial is to quantify precision of measurement of two peaks of vGRF, peaks that correspond to 'maximum weight acceptance' and 'push-off', also called 'heelmax load' and 'toemax load' for healthy adults by FeetMe® insoles compared with Vicon and force plates during a free walk test.
Measured: between February 2022 and November 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Feb 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- FeetMe
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hopitaux de Saint-Maurice
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027762
- Sponsor's protocol ID
- 2021-A02409-32
- Acronym
- FeetMe-GRF
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: legal reasons
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vertical Ground Reaction Force Measurement During Walking With Feetme® Insoles in Healthy Adults
- ClinicalTrials.gov ID
- NCT06027762
- Acronym / sponsor ID
- FeetMe-GRF / 2021-A02409-32
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- FeetMeIndustry (pharma, biotech, devices)
- Collaborators
- Hopitaux de Saint-Maurice
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 7 Sep 2023 (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.
The objective of the present study is to demonstrate the validity and reliability of vGRF and other gait parameters measurement in healthy adults while walking with FeetMe® insoles compared to force plates (AMTI BP400600) and video motion capture system (Vicon NEXUS and MX-T40) .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Groupe | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Adults between 18 and 85 years old without gait pathologies
Key inclusion criteria (15 listed)
- Between the ages of 18 and 80.
- Shoe size between 35 to 46.
- Body weight from 40kg to 120kg.
- Able to walk for 30 mins without assistance.
- Comfortable with using a smartphone.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
precision of measurement of 'maximum weight acceptance' and 'push-off' peaks in healthy adults by FeetMe® insoles
Time frame: between February 2022 and November 2022
The primary objective of this clinical trial is to quantify precision of measurement of two peaks of vGRF, peaks that correspond to 'maximum weight acceptance' and 'push-off', also called 'heelmax load' and 'toemax load' for healthy adults by FeetMe® insoles compared with Vicon and force plates during a free walk test.
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 7 Sep 2023.
- Individual participant dataSharing planned: No. legal reasons
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Screening Protocol
Pain
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 Healthy Volunteers, run by FeetMe at 1 site in France.
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 15 inclusion and 0 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 7 Sep 2023. 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 France. 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?
precision of measurement of 'maximum weight acceptance' and 'push-off' peaks in healthy adults by FeetMe® insoles (time frame: between February 2022 and November 2022). 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 7 Sep 2023.