Healthy SubjectNCT03662399
Francis Biomechanics Study
A study testing Insoles and Standard shoe in people with Healthy Subject, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Belgium.
Trial summary
This study aims to evaluate the effect of a range of pre-formed orthoses on function of the foot and leg to generate technical data on how the individual insoles impact gait, distribution of load and stability in a healthy population. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Insoles and Standard shoe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Jun 2018to 10 Aug 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between the ages of 18-60 years inclusive.
- Subjects who are able to give written informed consent.
- Subjects who are able to understand the study, cooperate with the study procedures and are able to attend all study assessments.
- Subjects who are willing to wear a t-shirt and shorts during the study assessments.
- Subjects who are willing and able to stand for a minimum of two hours at a time during the study assessments.
- Subject with shoe size between 4.5 to 11 (UK) / 37 to 45 (European).
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- Subjects who can achieve the acceptable fit of standard shoes.
- Subjects who do not have any walking impairments and can walk without distress. This will be determined through walking at a speed of 3-5 kmph for a distance of 30 m.
- Subjects with a Foot Posture Index (FPI) between 6 and 9 showing mild pronation as determined by the study Investigator or designees.
- Subjects with a BMI between 18.5 - 24.9 kg/m2.
Who cannot join
- Subjects who are pregnant or who have given birth within the last 6 months.
- Subjects who have a medical condition that could compromise the use of the orthotic insoles (peripheral vascular disease or sensory neuropathy).
- Subjects that have Leg Length Discrepancy (LLD) of more than 5 mm. This will be determined using the Downings Sign (7), a test which is used to establish actual versus functional LLD. This will be cross-referenced with anatomical land marks.
- Subjects that use prescribed or self-administrated orthotics to correct biomechanical or other issues.
- Subject that have received any previous orthotic treatment.
- Subjects who have a current or previous injury that has prevented their usual activities for more than 3 weeks in the last year.
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- Subjects with history of lower limb or foot surgery, inflammatory disease, neurological disease, diabetes, leg ulceration, skin grafts or any other condition that in the opinion of the Investigator or designees could interfere with the assessments in this study.
- Subjects having ischemia or poor blood supply to the feet, Charcot Arthropathy, autoimmune disease (e.g. rheumatoid arthritis) and connective tissue disease (e.g. scleroderma).
- Subjects demonstrating symptoms of macrovascular diseases (e.g. angina, stroke).
- Individuals suffering from other conditions affecting the feet, such as infectious foot conditions, which in the opinion of the Investigator or designees, would interfere with the generation of data and risk the spread of infection to other subjects through the use of the standard shoe.
- Individuals with broken/irritated or damaged skin on their feet.
- Individuals suffering from relevant product allergies or sensitivities.
- Individuals who have consulted a healthcare professional for a gait related or foot pain issue.
- Individuals who were previously in another clinical study within the last 3 months prior to screening assessment.
- Employees who are directly involved with the study at study site.
- Any partner or first degree relative of anyone that has a role in the study at the CRO/Site/Sponsor.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital
Liège
About this study
Official title: A Single Centre, Cross-over Study to Evaluate the Effect of a Range of Pre-formed Orthoses on Function of the Foot and Leg to Generate Technical Data on How the Individual Insoles Impact Gait, Distribution of Load and Stability in a Healthy Population.
This study aims to evaluate the effect of a range of pre-formed orthoses on function of the foot and leg to generate technical data on how the individual insoles impact gait, distribution of load and stability in a healthy population.
- Conditions
- Healthy Subject
- Being tested
- Insoles, Standard shoe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsolesDevice
Orthotic Insoles
Standard shoeOther
Also called Non-Investigational product
Standard shoe
| Study group | Role | What they receive |
|---|---|---|
| Insole A | Experimental | Investigational product - Insole A Receives: Device: Insoles |
| Insole B | Experimental | Investigational product - Insole B Receives: Device: Insoles |
| Insole C | Experimental | Investigational product - Insole C Receives: Device: Insoles |
| Insole D | Experimental | Investigational product - Insole D Receives: Device: Insoles |
| Insole E | Experimental | Investigational product - Insole E Receives: Device: Insoles |
| Insole F | Experimental | Investigational product - Insole F Receives: Device: Insoles |
| Insole G | Experimental | Non-Investigational product - Standard shoe Receives: Other: Standard shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Peak pressure (PP)
Measured: 2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Pressure time integral (PTI)
Measured: 2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Force time integral (FTI)
Measured: 2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Contact area (CA)
Measured: 2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time to peak pressure (TPP)
Measured: 2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Contact time (CT)
Measured: 2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Centre of pressure (balance/stability)
Measured: 2 hours
3D gait analysis
Rearfoot angle at contact
Measured: 2 hours
3D gait analysis
Maximum rearfoot angle
Measured: 2 hours
3D gait analysis
Rearfoot excursion
Measured: 2 hours
3D gait analysis
Rearfoot eversion velocity
Measured: 2 hours
3D gait analysis
Stride Velocity (m/s)
Measured: 2 hours
3D gait analysis
Tibial rotation
Measured: 2 hours
3D gait analysis
Displacement of centre of mass
Measured: 2 hours
3D gait analysis
Hip drop
Measured: 2 hours
3D gait analysis
Thoracic rotation
Measured: 2 hours
3D gait analysis
Hip drop velocity
Measured: 2 hours
3D gait analysis
Thoracic rotation velocity
Measured: 2 hours
3D gait analysis
kinetic data. This includes vertical force, vertical impulse, ankle inversion moment, ankle eversion moment, knee adduction moment, hip adduction moment and hip abduction moment (maximums, measured in BW).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start13 Jun 2018
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-François Kaux, Professor, Principal investigator, Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital , Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662399
- Sponsor's protocol ID
- NPD85301
- Status last verified
- Sep 2018
- First submitted
- 6 Jun 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Cross-over Study to Evaluate the Effect of a Range of Pre-formed Orthoses on Function of the Foot and Leg to Generate Technical Data on How the Individual Insoles Impact Gait, Distribution of Load and Stability in a Healthy Population.
- ClinicalTrials.gov ID
- NCT03662399
- Acronym / sponsor ID
- NPD85301
- Conditions
- Healthy Subject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 7 Sep 2018 (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 evaluate the effect of a range of pre-formed orthoses on function of the foot and leg to generate technical data on how the individual insoles impact gait, distribution of load and stability in a healthy population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Insole A | Experimental | Device: InsolesInvestigational product - Insole A |
| Insole B | Experimental | Device: InsolesInvestigational product - Insole B |
| Insole C | Experimental | Device: InsolesInvestigational product - Insole C |
| Insole D | Experimental | Device: InsolesInvestigational product - Insole D |
| Insole E | Experimental | Device: InsolesInvestigational product - Insole E |
| Insole F | Experimental | Device: InsolesInvestigational product - Insole F |
| Insole G | Experimental | Other: Standard shoeNon-Investigational product - Standard shoe |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male and female subjects between the ages of 18-60 years inclusive.
- Subjects who are able to give written informed consent.
- Subjects who are able to understand the study, cooperate with the study procedures and are able to attend all study assessments.
- Subjects who are willing to wear a t-shirt and shorts during the study assessments.
- Subjects who are willing and able to stand for a minimum of two hours at a time during the study assessments.
Key exclusion criteria (16 listed)
- Subjects who are pregnant or who have given birth within the last 6 months.
- Subjects who have a medical condition that could compromise the use of the orthotic insoles (peripheral vascular disease or sensory neuropathy).
- Subjects that have Leg Length Discrepancy (LLD) of more than 5 mm. This will be determined using the Downings Sign (7), a test which is used to establish actual versus functional LLD. This will be cross-referenced with anatomical land marks.
- Subjects that use prescribed or self-administrated orthotics to correct biomechanical or other issues.
- Subject that have received any previous orthotic treatment.
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 |
|---|---|---|
| InsolesOrthotic Insoles | Device | Insole A, Insole B, Insole C, Insole D, Insole E, Insole F |
| Standard shoeAlso: Non-Investigational productStandard shoe | Other | Insole G |
Primary outcome
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time frame: 2 hours
Peak pressure (PP)
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time frame: 2 hours
Pressure time integral (PTI)
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time frame: 2 hours
Force time integral (FTI)
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time frame: 2 hours
Contact area (CA)
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time frame: 2 hours
Time to peak pressure (TPP)
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time frame: 2 hours
Contact time (CT)
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time frame: 2 hours
Centre of pressure (balance/stability)
3D gait analysis
Time frame: 2 hours
Rearfoot angle at contact
3D gait analysis
Time frame: 2 hours
Maximum rearfoot angle
3D gait analysis
Time frame: 2 hours
Rearfoot excursion
3D gait analysis
Time frame: 2 hours
Rearfoot eversion velocity
3D gait analysis
Time frame: 2 hours
Stride Velocity (m/s)
3D gait analysis
Time frame: 2 hours
Tibial rotation
3D gait analysis
Time frame: 2 hours
Displacement of centre of mass
3D gait analysis
Time frame: 2 hours
Hip drop
3D gait analysis
Time frame: 2 hours
Thoracic rotation
3D gait analysis
Time frame: 2 hours
Hip drop velocity
3D gait analysis
Time frame: 2 hours
Thoracic rotation velocity
3D gait analysis
Time frame: 2 hours
kinetic data. This includes vertical force, vertical impulse, ankle inversion moment, ankle eversion moment, knee adduction moment, hip adduction moment and hip abduction moment (maximums, measured in BW).
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 2018.
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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.
Jean-François Kaux, Professor principal investigator
Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital , Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insoles and Standard shoe in people with Healthy Subject, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Belgium.
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 10 inclusion and 16 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 2018. 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 Belgium. 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?
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait (time frame: 2 hours). The study lists 19 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 7 Sep 2018.