Effects of Custom CAD/CAM Insoles on Plantar Pressure Distribution in Individuals With Foot Deformities: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Maximum Plantar Pressure
研究概览
简要总结
This randomized controlled trial will investigate the effects of custom CAD/CAM insoles on plantar pressure distribution and gait parameters in individuals with foot deformities, such as pes planus, pes cavus, and hallux valgus. A total of 30 participants will be randomly assigned to either the intervention group, receiving custom CAD/CAM insoles, or the control group, receiving no insole intervention.
Plantar pressure measurements will be performed using the As200 Gait Scan Pedobarography System at baseline and after eight weeks. Static and dynamic plantar pressure variables, contact area, and center of pressure displacement will be assessed, along with gait parameters including step length, step time, and walking speed.
The results of this study may contribute to the development of effective conservative treatment strategies to improve foot biomechanics and reduce pressure-related complications in individuals with foot deformities.
详细描述
This randomized controlled trial will evaluate the impact of custom CAD/CAM insoles on plantar pressure distribution and gait parameters in individuals with clinically diagnosed foot deformities. Thirty eligible participants, aged 18-65 years, will be randomly assigned to one of two groups:
Intervention Group: Participants will receive custom-designed CAD/CAM insoles based on 3D plantar scans and pedobarographic analysis.
Control Group: Participants will not receive insole intervention during the eight-week study period.
Baseline assessments will include demographic data, anthropometric foot measurements, and pedobarographic analysis using the As200 Gait Scan System. The intervention group will be instructed to use the custom insoles daily for eight consecutive weeks, while the control group will maintain their usual footwear without insoles.
After eight weeks, all participants will undergo the same measurement procedures. Primary outcome measures will include maximum and mean plantar pressures, contact area, and center of pressure displacement. Secondary outcomes will include step length, step time, walking speed, and regional pressure distribution across foot segments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to group allocation to prevent measurement bias during data collection and analysis.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years
- •Clinically diagnosed with a foot deformity (e.g., pes planus, pes cavus, hallux valgus)
- •Able to use custom insoles for at least six months
- •Able to stand and walk for pedobarographic measurements
- •Willing to participate and provide informed consent
排除标准
- •Presence of neurological or systemic diseases affecting foot function (e.g., diabetic neuropathy)
- •History of lower extremity surgery in the last six months
- •Severe musculoskeletal conditions impairing sensorimotor function
- •Any condition preventing compliance with insole use
- •Contraindications for participating in gait or pressure measurements
结局指标
主要结局
Maximum Plantar Pressure
时间窗: Baseline and 8 weeks after intervention.
Maximum plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Mean Plantar Pressure
时间窗: Baseline and 8 weeks after intervention.
Mean plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Plantar Contact Area
时间窗: Baseline and 8 weeks after intervention.
Plantar contact area (cm²) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Center of Pressure (COP) Displacement
时间窗: Baseline and 8 weeks after intervention.
Center of pressure (COP) displacement (mm) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
次要结局
- Step Length(Baseline and 8 weeks after intervention)
- Step Time(Baseline and 8 weeks after intervention)
- Walking Speed(Baseline and 8 weeks after intervention.)
- Regional Pressure Distribution(Baseline and 8 weeks after intervention.)
研究者
Başar Öztürk
Associate Professor, Department of Physiotherapy and Rehabilitation (English), Faculty of Health Sciences, Fenerbahçe University
Fenerbahce University