Knee Indentation for Soft Tissues Mechanical Characterization and Modeling (KneeDent)
Indentation for the Mechanical Characterization of Soft Tissues in Contact With a Knee Orthosis: Towards Simulation of the Leg-Orthosis Interface.
Knee osteoarthritis is a common cause of disability, affecting more than 650 million people aged 40 and over worldwide in 2020. To relieve pain and improve mobility, some patients use knee orthoses . However, the effectiveness of these devices is not universally agreed upon, and users report widely varying levels of satisfaction.
This study aims to understand how the body responds to these orthoses from a biomechanical perspective, and in particular to quantify the interactions with soft tissues (skin, adipose tissue and muscles). To better understand this interaction, the authors propose to characterize soft tissue behavior on an individual basis using an indentation technique. In practice, this involves pressing on the soft tissues with an ultrasound probe to measure their stiffness at the interface between the leg and the orthosis.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ille-et-Vilaine
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Bruz, Ille-et-Vilaine, France, 35170
- Ens Rennes
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
Participant whose skin is intact on at least one of the two legs, in the tested area.
Participant able to understand simple instructions, conditioning guidelines, and to provide informed consent.
Adult over the age of 50, not under guardianship. Participant having signed the study participation consent form.
Non-inclusion Criteria
Persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 (minors, protected adults, etc.) Skin lesions, inflammation, or acute local pain on the tested leg. Neuromuscular pathology preventing controlled muscle contraction. Joint pain preventing the performance of everyday activities (e.g., walking, rising from a chair, climbing stairs…).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Knee indentation
under different level of thigh and shank muscles contraction, we indent specific zones of the knee region to assess its stiffness and define a mechanical model of response for knee orthosis design
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we push the soft tissue in the indentation zone with an instrumented elastographic probe, allowing to assess force vs tissue thickness.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
force-displacement curves
Time Frame: through study completion, an average of 1 year
|
Using the force below and displacement below, this a construction of the relative displacement with regard to the applied force
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Indentation force (N)
Time Frame: through study completion, an average of 1 year
|
Force being applied by the indenter on the zone to be indented
|
through study completion, an average of 1 year
|
|
Displacement (mm)
Time Frame: through study completion, an average of 1 year
|
using motion capture, this is the assessment of the relative displacement of the probe with regard to the resting position during an indentation
|
through study completion, an average of 1 year
|
|
Height (m)
Time Frame: through study completion, an average of 1 year
|
Height of the subject, measured with a standard ruler
|
through study completion, an average of 1 year
|
|
Weight (kg)
Time Frame: through study completion, an average of 1 year
|
measured with a standard scale
|
through study completion, an average of 1 year
|
|
Muscle activity (mV)
Time Frame: through study completion, an average of 1 year
|
from the main flexors and extensors of the thigh, using EMGs
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- InriaRennes
- Étude N°26.00181.001002 (Other Identifier: Comité de protection des personnes Ile de France III)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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