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Completed

NCT Number: NCT03662399

Francis Biomechanics Study

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.

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Key information

Conditions

Healthy Subject

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital

Liège, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Insoles

Device

Orthotic Insoles

Standard shoe

Other

Standard shoe

Other names: Non-Investigational product

Primary outcomes

  1. In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait

    Time frame: 2 hours

    Peak pressure (PP)

  2. In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait

    Time frame: 2 hours

    Pressure time integral (PTI)

  3. In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait

    Time frame: 2 hours

    Force time integral (FTI)

  4. In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait

    Time frame: 2 hours

    Contact area (CA)

  5. In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait

    Time frame: 2 hours

    Time to peak pressure (TPP)

  6. In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait

    Time frame: 2 hours

    Contact time (CT)

  7. In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait

    Time frame: 2 hours

    Centre of pressure (balance/stability)

  8. 3D gait analysis

    Time frame: 2 hours

    Rearfoot angle at contact

  9. 3D gait analysis

    Time frame: 2 hours

    Maximum rearfoot angle

  10. 3D gait analysis

    Time frame: 2 hours

    Rearfoot excursion

  11. 3D gait analysis

    Time frame: 2 hours

    Rearfoot eversion velocity

  12. 3D gait analysis

    Time frame: 2 hours

    Stride Velocity (m/s)

  13. 3D gait analysis

    Time frame: 2 hours

    Tibial rotation

  14. 3D gait analysis

    Time frame: 2 hours

    Displacement of centre of mass

  15. 3D gait analysis

    Time frame: 2 hours

    Hip drop

  16. 3D gait analysis

    Time frame: 2 hours

    Thoracic rotation

  17. 3D gait analysis

    Time frame: 2 hours

    Hip drop velocity

  18. 3D gait analysis

    Time frame: 2 hours

    Thoracic rotation velocity

  19. 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).

Sponsors and collaborators

Lead sponsor

Reckitt Benckiser Healthcare (UK) Limited

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2018
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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