Clinical Effects of the Medial Longitudinal Arch Slope of a Plantar Orthosis
NCT Number: NCT06474585
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pronated Left Foot|Pronated Right Foot
Interventions: DEVICE: Plantar orthosis
Sponsor: Universidad Complutense de Madrid
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2024-12-20

Summary:
The objective of this clinical trial is to compare the effects of the geometry of the medial longitudinal arch (MLA) of the insole on acceleration impacts during gait, measured using an accelerometry system, in patients with pain related to the presence of a pronated foot morphotype. The main questions it aims to answer are:

Is the slope of the medial longitudinal arch of the orthotic treatment a factor that reduces the peak tibial accelerometry in a symptomatic foot with a medially oriented subtalar joint axis? To assess the predictive effect of changes in acceleration impacts on the patient's painful symptoms.

The researchers will compare the MLA of the insole taken in a standing position with the MLA of the insole taken in a sitting position (the treatment applied in routine clinical practice) to evaluate if changing the slope of the MLA generates changes in the tibial acceleration impacts.

The participants:

Must use the insoles to carry out their daily activities, except for sleeping or bathing.

The first review of the orthotic treatment will be conducted 3 months after the treatment initiation.

Primary Outcome Measures: Maximum tibial acceleration (g)., Tibial axial acceleration corresponds to a line bisecting the proximal and distal ends of the tibia in the frontal and sagittal planes. Longitudinal acceleration provides a measure of impact accelerations at the knee moving longitudinally along the tibia and has previously been identified as a potential indicator of injury risk., The maximum tibial acceleration (g) is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.
Secondary Outcome Measures: Maximum head acceleration (g), Peak acceleration is the maximum amplitude of the acceleration signal, providing information about the mechanical stress that the shock wave causes in the body. This variable can be correlated with ground reaction forces measured on a force platform., The maximum head acceleration (g) is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.|Magnitude of head acceleration (g)., It is defined as the difference between the maximum acceleration and the minimum acceleration of the head., The magnitude of head acceleration (g) is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.|Acceleration ratio (38-70) in head (g/s)., It's the slope of the impact, that is, the variation in acceleration from ground contact time until reaching the peak, Acceleration ratio (38-70) in head (g/s). It is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system|Magnitude of tibial acceleration (g), It is defined as the difference between the maximum acceleration and the minimum acceleration of the tibia., Magnitude of tibial acceleration (g). It is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.|Acceleration ratio (30-70) in tibia (g/s)., It is the slope of the impact, that is, the variation in acceleration from ground contact time until reaching the maximum, Acceleration ratio (30-70) in tibia (g/s). It is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.|Impact attenuation (%), It is conceptualized as the reduction in the acceleration signal from one location to another, typically from the tibia to the head. It is obtained by calculating the difference in magnitude between the maximum peak in the tibia, expressed as a percentage., Impact attenuation (%). It is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.
Other Outcome Measures: Foot posture Index, The Foot Posture Index (FPI-6), first described by Redmond et al., is known to be a reliable and validated test for quantifying the static position of the foot. Unlike other instruments, the FPI-6 covers most segments of the foot and all three planes of movement, The test will be conducted on the patient before and after delivering the plantar orthosis.|Relaxed calcaneal position, The relaxed calcaneal position under weight-bearing assesses the degrees of inclination of the calcaneus towards valgus or varus in the frontal plane during closed kinetic chain., The patient will be assessed before and after delivering the plantar orthosis using goniometry.|Orientation of the axis of rotation of the subastragalar joint, It studies the axis of the subtalar joint (STJ), evaluating that normal values place the axis of the STJ when passing through the first intermetatarsal space, potentially showing a medialized axis if it passes medial to the normal position, and indicating a lateralized axis if it is displaced towards lateral areas relative to the normal axis., The patient will be assessed before and after delivering the plantar orthosis|Angle of the medial longitudinal arch, The angle of the medial longitudinal arch (MLA). The MLA angle is defined as the angle formed by two vectors: one passing from the midpoint of the medial malleolus to the navicular tuberosity, and the other passing from the midpoint of the medial aspect of the first metatarsal head to the navicular tuberosity., The patient will be assessed before and after the delivery of the plantar orthosis using goniometry.|Navicular Drop Test Navicular Drop Test Navicular Drop test, It shows the change in the height of the tarsal navicular when the patient moves into bipedal stance, serving as an indicative test of the decrease in height and the excess pronation of the foot during dynamic movement., The patient will be measured before and after receiving the plantar orthosis using goniometry.|Pain according to the Visual Analog Scale (VAS), It is a reliable measure represented by a continuous scale, depicting pain, comfort perceived in different colors, numbers, shapes, and images. It is a validated tool used in foot and ankle pathology, often to quantify the intensity of pain, The patient will be assessed before and after delivering the plantar orthosis based on the VAS (Visual Analog Scale).