Francis Biomechanics Study

Healthy Subject Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662399
• Other study ID #: NPD85301
• Status: Completed
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: August 10, 2018

Study information

• Verified date: September 2018
• Source: Reckitt Benckiser Healthcare (UK) Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Device:
• Insoles
Orthotic Insoles

Other:
• Standard shoe
Standard shoe

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Reckitt Benckiser Healthcare (UK) Limited

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait	Peak pressure (PP)	2 hours
Primary	In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait	Pressure time integral (PTI)	2 hours
Primary	In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait	Force time integral (FTI)	2 hours
Primary	In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait	Contact area (CA)	2 hours
Primary	In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait	Time to peak pressure (TPP)	2 hours
Primary	In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait	Contact time (CT)	2 hours
Primary	In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait	Centre of pressure (balance/stability)	2 hours
Primary	3D gait analysis	Rearfoot angle at contact	2 hours
Primary	3D gait analysis	Maximum rearfoot angle	2 hours
Primary	3D gait analysis	Rearfoot excursion	2 hours
Primary	3D gait analysis	Rearfoot eversion velocity	2 hours
Primary	3D gait analysis	Stride Velocity (m/s)	2 hours
Primary	3D gait analysis	Tibial rotation	2 hours
Primary	3D gait analysis	Displacement of centre of mass	2 hours
Primary	3D gait analysis	Hip drop	2 hours
Primary	3D gait analysis	Thoracic rotation	2 hours
Primary	3D gait analysis	Hip drop velocity	2 hours
Primary	3D gait analysis	Thoracic rotation velocity	2 hours
Primary	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