Francis Biomechanics Study

September 5, 2018 updated by: Reckitt Benckiser Healthcare (UK) Limited

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium
        • Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male and female subjects between the ages of 18-60 years inclusive.
  2. Subjects who are able to give written informed consent.
  3. Subjects who are able to understand the study, cooperate with the study procedures and are able to attend all study assessments.
  4. Subjects who are willing to wear a t-shirt and shorts during the study assessments.
  5. Subjects who are willing and able to stand for a minimum of two hours at a time during the study assessments.
  6. Subject with shoe size between 4.5 to 11 (UK) / 37 to 45 (European).
  7. Subjects who can achieve the acceptable fit of standard shoes.
  8. 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.
  9. Subjects with a Foot Posture Index (FPI) between 6 and 9 showing mild pronation as determined by the study Investigator or designees.
  10. Subjects with a BMI between 18.5 - 24.9 kg/m2.

Exclusion Criteria:

  1. Subjects who are pregnant or who have given birth within the last 6 months.
  2. Subjects who have a medical condition that could compromise the use of the orthotic insoles (peripheral vascular disease or sensory neuropathy).
  3. 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.
  4. Subjects that use prescribed or self-administrated orthotics to correct biomechanical or other issues.
  5. Subject that have received any previous orthotic treatment.
  6. Subjects who have a current or previous injury that has prevented their usual activities for more than 3 weeks in the last year.
  7. 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.
  8. 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).
  9. Subjects demonstrating symptoms of macrovascular diseases (e.g. angina, stroke).
  10. 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.
  11. Individuals with broken/irritated or damaged skin on their feet.
  12. Individuals suffering from relevant product allergies or sensitivities.
  13. Individuals who have consulted a healthcare professional for a gait related or foot pain issue.
  14. Individuals who were previously in another clinical study within the last 3 months prior to screening assessment.
  15. Employees who are directly involved with the study at study site.
  16. Any partner or first degree relative of anyone that has a role in the study at the CRO/Site/Sponsor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Insole A
Investigational product - Insole A
Device: Insoles
Orthotic Insoles
Experimental: Insole B
Investigational product - Insole B
Device: Insoles
Orthotic Insoles
Experimental: Insole C
Investigational product - Insole C
Device: Insoles
Orthotic Insoles
Experimental: Insole D
Investigational product - Insole D
Device: Insoles
Orthotic Insoles
Experimental: Insole E
Investigational product - Insole E
Device: Insoles
Orthotic Insoles
Experimental: Insole F
Investigational product - Insole F
Device: Insoles
Orthotic Insoles
Experimental: Insole G
Non-Investigational product - Standard shoe
Other: Standard shoe
Standard shoe
Other Names:
  • Non-Investigational product

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time Frame: 2 hours
Peak pressure (PP)
2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time Frame: 2 hours
Pressure time integral (PTI)
2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time Frame: 2 hours
Force time integral (FTI)
2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time Frame: 2 hours
Contact area (CA)
2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time Frame: 2 hours
Time to peak pressure (TPP)
2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time Frame: 2 hours
Contact time (CT)
2 hours
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
Time Frame: 2 hours
Centre of pressure (balance/stability)
2 hours
3D gait analysis
Time Frame: 2 hours
Rearfoot angle at contact
2 hours
3D gait analysis
Time Frame: 2 hours
Maximum rearfoot angle
2 hours
3D gait analysis
Time Frame: 2 hours
Rearfoot excursion
2 hours
3D gait analysis
Time Frame: 2 hours
Rearfoot eversion velocity
2 hours
3D gait analysis
Time Frame: 2 hours
Stride Velocity (m/s)
2 hours
3D gait analysis
Time Frame: 2 hours
Tibial rotation
2 hours
3D gait analysis
Time Frame: 2 hours
Displacement of centre of mass
2 hours
3D gait analysis
Time Frame: 2 hours
Hip drop
2 hours
3D gait analysis
Time Frame: 2 hours
Thoracic rotation
2 hours
3D gait analysis
Time Frame: 2 hours
Hip drop velocity
2 hours
3D gait analysis
Time Frame: 2 hours
Thoracic rotation velocity
2 hours
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).
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Reckitt Benckiser Healthcare (UK) Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-François Kaux, Professor, Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital , Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NPD85301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Subject

Clinical Trials on Insoles

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings