Francis Biomechanics Study

NCT03662399 | Completed

• 1 other identifier: NPD85301
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (19)

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

  Peak pressure (PP)

  2 hours

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

  Pressure time integral (PTI)

  2 hours

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

  Force time integral (FTI)

  2 hours

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

  Contact area (CA)

  2 hours

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

  Time to peak pressure (TPP)

  2 hours

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

  Contact time (CT)

  2 hours

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

  Centre of pressure (balance/stability)

  2 hours

• 3D gait analysis

  Rearfoot angle at contact

  2 hours

• 3D gait analysis

  Maximum rearfoot angle

  2 hours

• 3D gait analysis

  Rearfoot excursion

  2 hours

• 3D gait analysis

  Rearfoot eversion velocity

  2 hours

• 3D gait analysis

  Stride Velocity (m/s)

  2 hours

• 3D gait analysis

  Tibial rotation

  2 hours

• 3D gait analysis

  Displacement of centre of mass

  2 hours

• 3D gait analysis

  Hip drop

  2 hours

• 3D gait analysis

  Thoracic rotation

  2 hours

• 3D gait analysis

  Hip drop velocity

  2 hours

• 3D gait analysis

  Thoracic rotation velocity

  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).

  2 hours

Study Arms (7)

Insole A

EXPERIMENTAL

Investigational product - Insole A

Device: Insoles

Insole B

EXPERIMENTAL

Investigational product - Insole B

Device: Insoles

Insole C

EXPERIMENTAL

Investigational product - Insole C

Device: Insoles

Insole D

EXPERIMENTAL

Investigational product - Insole D

Device: Insoles

Insole E

EXPERIMENTAL

Investigational product - Insole E

Device: Insoles

Insole F

EXPERIMENTAL

Investigational product - Insole F

Device: Insoles

Insole G

EXPERIMENTAL

Non-Investigational product - Standard shoe

Other: Standard shoe

Interventions

Insoles DEVICE

Orthotic Insoles

Insole A; Insole B; Insole C; Insole D; Insole E; Insole F

Standard shoe OTHER

Standard shoe

Also known as: Non-Investigational product

Insole G

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: 40-60% Male and female recruitment
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital

Liège, Belgium

Location

MeSH Terms

Interventions

Foot Orthoses

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Jean-François Kaux, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: September 7, 2018
• Study Start: June 13, 2018
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

BE (1)