Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Foot Orthoses.
- Who it may be relevant to
- Registry conditions: Patellofemoral Joint, Flatfoot. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Does Correction of Pronated Foot Posture Alter Patellofemoral Alignment? A Weight-Bearing Cone Beam CT Proof-of-Concept Study in Individuals With Flexible Flatfoot
Overview
This study will look at whether correcting a flat foot position with foot orthoses, also called shoe inserts, can change the position of the kneecap during standing. Some people with flexible flatfoot have a foot position that may affect how the lower leg and knee are aligned. This may influence the way the kneecap sits or tilts in relation to the thigh bone. Foot orthoses are often used for knee and foot problems, but it is not clear whether they directly change kneecap position when a person is standing and bearing weight. The study will include adults with flexible flatfoot. Each participant will have low-dose, three-dimensional weight-bearing cone beam CT scans while standing in different foot positions: their natural foot position, with foot orthoses, and with foot orthoses inside a neutral running shoe. Scans will be performed with the knees straight and slightly bent. The main hypothesis is that correcting a pronated flat foot position with foot orthoses will reduce sideways tilt and outward shift of the kneecap compared with the participant's natural foot position. The study will also examine whether changes in foot position are accompanied by changes in lower-limb rotation. This study does not test whether foot orthoses reduce pain. Instead, it is designed to understand the immediate mechanical effect of foot correction on kneecap position.
Interventions
- Device Foot Orthoses
Standardized prefabricated foot orthoses will be used to correct a pronated foot posture toward neutral rearfoot alignment during weight-bearing. Three orthosis configurations will be available, differing in medial arch height and degree of lateral calcaneal tilt. For each participant, the orthosis that best achieves neutral rearfoot alignment will be selected. If forefoot varus prevents neutral rearfoot alignment, an additional medial forefoot wedge may be applied under the first metatarsal. T
Primary outcome measures
- Change in Lateral Patellar Tilt [Time frame: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
- Change in Bisect Offset [Time frame: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
Secondary outcome measures (5)
- Change in Tibial Tuberosity-Trochlear Groove Distance [Time frame: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
- Change in Transmalleolar Rotation Across Foot Posture Conditions [Time frame: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
- Change in Tibial Rotation Across Foot Posture Conditions [Time frame: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
- Change in Femoral Rotation Across Foot Posture Conditions [Time frame: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
- Change in Patellar Rotation Across Foot Posture Conditions [Time frame: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
Eligibility criteria
Inclusion criteria
- Age 18-35 years
- Pronated foot posture, defined as a Foot Posture Index (FPI) score of ≥ +6, including a calcaneal frontal plane position sub-score of +2. 25,26
○ A trained examiner will assess FPI; inclusion is based on the right foot.
- Flexible flatfoot deformity, defined as restoration of the medial longitudinal arch during lift of the first toe.
Exclusion criteria
- Knee pain during standing or at 20° knee flexion
- Clinical signs of tibiofemoral instability
- Previous knee or foot surgery
- History of patellar dislocation
- Neuromuscular disease
- Pregnancy
- Inability to perform full weight bearing during scans
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Sportsmedicinsk Center, Frederikshavn Sygehus — Frederikshavn
Identifiers
NCT: NCT07678840 · N-20260014