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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ille-et-Vilaine
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Bruz, Ille-et-Vilaine, Frankrike, 35170
- Ens Rennes
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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…).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
force-displacement curves
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Indentation force (N)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: through study completion, an average of 1 year
|
measured with a standard scale
|
through study completion, an average of 1 year
|
|
Muscle activity (mV)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- InriaRennes
- Étude N°26.00181.001002 (Annen identifikator: Comité de protection des personnes Ile de France III)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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