Does Correction of Pronated Foot Posture Alter Patellofemoral Alignment? A Weight-Bearing Cone Beam CT Proof-of-Concept Study in Individuals With Flexible Flatfoot
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Lateral Patellar Tilt
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 +
- •○ 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.
排除标准
- •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
研究组 & 干预措施
Foot Posture Conditions
Participants will undergo standardized weight-bearing cone beam CT scans under three foot posture conditions: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a standardized neutral running shoe. Each condition will be assessed with the knees fully extended and at 20 degrees of knee flexion.
The foot orthosis will be selected for each participant to correct the rearfoot toward neutral alignment. If needed, an additional forefoot wedge may be used to achieve neutral alignment. The same orthotic correction will be maintained across the relevant scan conditions.
干预措施: Foot Orthoses (Device)
结局指标
主要结局
Change in Lateral Patellar Tilt
时间窗: 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
Lateral patellar tilt will be measured in degrees on standardized weight-bearing cone beam CT images. The measure describes the sideways tilt of the kneecap in relation to the thigh bone. It is defined as the angle between the transverse axis of the patella and the posterior condylar axis of the femur. Measurements will be performed for each foot posture condition: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a neutral running shoe. Measurements will be assessed at both 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
Change in Bisect Offset
时间窗: 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
Bisect offset will be measured as a percentage on standardized weight-bearing cone beam CT images. The measure describes the sideways position of the kneecap in relation to the groove of the thigh bone. It is defined as the percentage of lateral displacement of the midpoint of the patella from the midpoint of the trochlear groove. Higher percentages indicate greater lateral displacement of the kneecap. Measurements will be performed for each foot posture condition: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a neutral running shoe. Measurements will be assessed at both 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
次要结局
- Change in Tibial Tuberosity-Trochlear Groove Distance(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(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(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(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(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)