Francis Biomechanics Study

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: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Device: Insoles; Other: Standard shoe

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Reckitt Benckiser Healthcare (UK) Limited
• Investigators: Principal Investigator: Jean-François Kaux, Professor, Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital , Belgium

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2018
• Primary Completion (Actual): August 10, 2018
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID 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