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Knee Indentation for Soft Tissues Mechanical Characterization and Modeling

Indentation for the Mechanical Characterization of Soft Tissues in Contact With a Knee Orthosis: Towards Simulation of the Leg-Orthosis Interface.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07640178
Acronym
KneeDent
Enrollment
20
Registered
2026-06-10
Start date
2026-03-19
Completion date
2026-04-24
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Characterization of the Knee Region

Brief summary

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.

Interventions

OTHERKnee indentation

we push the soft tissue in the indentation zone with an instrumented elastographic probe, allowing to assess force vs tissue thickness.

Sponsors

Centre de recherche Inria de l'Université de Rennes
Lead SponsorOTHER
Lyon 1 University
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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…).

Design outcomes

Primary

MeasureTime frameDescription
force-displacement curvesthrough study completion, an average of 1 yearUsing the force below and displacement below, this a construction of the relative displacement with regard to the applied force

Secondary

MeasureTime frameDescription
Indentation force (N)through study completion, an average of 1 yearForce being applied by the indenter on the zone to be indented
Displacement (mm)through study completion, an average of 1 yearusing motion capture, this is the assessment of the relative displacement of the probe with regard to the resting position during an indentation
Height (m)through study completion, an average of 1 yearHeight of the subject, measured with a standard ruler
Weight (kg)through study completion, an average of 1 yearmeasured with a standard scale
Muscle activity (mV)through study completion, an average of 1 yearfrom the main flexors and extensors of the thigh, using EMGs

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026