Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 主要终点
- Change in Pain Intensity Measured by 100 mm Visual Analog Scale
研究概览
简要总结
The purpose of this study is to compare computer aided design/computer aided manufacturing (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and also to decide whether they are necessary in treatment of painful flexible flatfoot.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer),
- •minimum of + 6 points on the foot posture index,
排除标准
- •treatment of the foot for at least six months,
- •leg length discrepancy of more than 1 cm,
- •history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.
研究组 & 干预措施
CAD/CAM
8-week follow-up with CAD/CAM insole and home based exercise program
干预措施: CAD/CAM Insole (Device)
Semi-custom
8-week follow-up with semi-custom insole and home based exercise program
干预措施: Semi-custom Insole (Device)
Control
8-week follow-up with placebo insole and home based exercise program
干预措施: Control (Other)
结局指标
主要结局
Change in Pain Intensity Measured by 100 mm Visual Analog Scale
时间窗: Baseline and week 8
The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels. Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week. Changes were calculated as the difference between 8-week follow-up and baseline results.
次要结局
- Change in Quality of Life Assessed With Short Form-36 Scale(Baseline and week 8)
研究者
Yasin YURT
Assist. Prof. Dr.
Eastern Mediterranean University