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Francis Biomechanics Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662399
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser Healthcare (UK) Limited

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.

Condition or disease Intervention/treatment Phase
Healthy Subject Device: Insoles Other: Standard shoe Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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.
Actual Study Start Date : June 13, 2018
Actual Primary Completion Date : August 10, 2018
Actual Study Completion Date : August 10, 2018

Resource links provided by the National Library of Medicine


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 Name: Non-Investigational product




Primary Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   40-60% Male and female recruitment
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662399


Locations
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Belgium
Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital
Liège, Belgium
Sponsors and Collaborators
Reckitt Benckiser Healthcare (UK) Limited
Investigators
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Principal Investigator: Jean-François Kaux, Professor Centre Hospitalier Universitaire de Liège, Avenue de L'Hòpital , Belgium
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Responsible Party: Reckitt Benckiser Healthcare (UK) Limited
ClinicalTrials.gov Identifier: NCT03662399    
Other Study ID Numbers: NPD85301
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No