Clinical trial NCT03662399: Francis Biomechanics 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
timeFrame: 2 hours
measure: In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
timeFrame: 2 hours
measure: In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
timeFrame: 2 hours
measure: In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
timeFrame: 2 hours
measure: In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
timeFrame: 2 hours
measure: In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
timeFrame: 2 hours
measure: In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
measure: 3D gait analysis
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital
Study officials:
affiliation: Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital , Belgium
name: Jean-François Kaux, Professor
role: PRINCIPAL_INVESTIGATOR
References: