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Development of Shape and Pressure Models for a Comprehensive Analysis of the Healthy Foot

Development of Shape and Pressure Models for a Comprehensive Analysis of the Healthy Foot - Pressure and Shape Models of the foot

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57386
Enrollment
20
Registered
2025-04-07
Start date
2025-04-24
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Voetdeformiteiten, maar niet in deze studie met gezonde proefpersonen Foot malformations malformed feet

Interventions

None listed

Sponsors

Ziekenhuisgroep Twente
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: This study includes healthy participants. A healthy participant is defined as a  person who:  Does not have a foot deformities like hallux valgus, Charcot foot, severe pes  planus or pes cavus or a clubfoot.  Does not have a medical history of foot surgeries  Has no current foot pain or functional limitations at rest, or when walking or  standing on bare foot  Has no neurological or systemic conditions affecting foot structure or sensory  and motor functions of the foot (e.g. diabetes mellitus, rheumatoid arthritis,  neuropathies)  Has a normal mobility and does not use walking aids.  Does not have vascular conditions affecting circulation in the foot.  The investigators expect to have a normal pressure plate profile. A normal  pressure plate profile is characterized by:  A plantar pressure distribution consistent with a physiological gait pattern,  with the highest pressure peaks located under the heel, the first and fifth  metatarsals, and the hallux.  A smooth roll-off of the foot, without extreme lateralization or medialization  of the pressure distribution.  Other inclusion criteria to be eligible to participate in this study are:  Age: Between 18 and 65 years  Sex: Both biological female and male participants will be included.  Informed Consent: the participant must be able to understand and provide  informed consent regarding the nature and goals of the study.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded  from participation in this study:  Participants who do not wish to be informed about unexpected medical findings  Foot Deformities: Presence of significant foot deformities.  Neuropathy: Any history of neuropathy or conditions affecting foot sensation.  Foot Surgery: History of foot surgery that may alter anatomical or  biomechanical characteristics.  Amputation: Any amputation of (part of) the lower extremities.  Skin Conditions: Any abnormal skin conditions, including ulcers or open wounds  on the foot.  Medical Implants: Presence of any medical implants or devices that may  interfere with MRI imaging.  Inability to stand for a period of 5 minutes.  Pregnancy: The exclusion of pregnant women is not only due to the safety  concerns of contrast agents, as no contrast is used in the MRI scans for this  study. Hormonal changes that can affect foot structure, potentially influencing  result interpretation, were also considered.  MRI Safety: Any other condition that would make MRI unsafe or unreliable.  Height > 200 cm  Weight > 150 kg  Can people with flat feet or orthotics participate?  People with mild flat feet (pes planus) or high arches (pes cavus) can  participate if they do not have functional complaints or pain at rest or when  walking or standing on bare foot. In such cases, their pressure profile is  considered part of the natural variation within a healthy population. If  abnormal pressure distributions are measured, these can be analysed as a  subgroup within the healthy participants.  People who wear orthotics can only participate if they exhibit a physiological  gait pattern and pressure distribution without orthotics during the measurement  and if they have no functional complaints or pain at rest or when walking or  standing on bare foot.

Design outcomes

Primary

MeasureTime frame
Main study parameters are (1) a workflow that creates a database of WB and non-WB MRI scans from the feet of 20 healthy subjects; (2) the difference in foot morphology between WB and non-WB conditions; (3) validation of the FEM by using the input of the healthy feet to match and compare the PP with empirical data of a pressure plate.

Secondary

MeasureTime frame
Secondary study parameters are (1) a relatively simple initial SSM of the foot that is developed by using the foot data of the 20 healthy subjects; (2) the plantar pressure of the healthy foot.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)