The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Change in Functional Reach Test(FRT) from pre to post-intervention.
研究概览
简要总结
Flexible flatfoot is a condition that increase the load of the foot structure.With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot.
详细描述
Flexible flatfoot is a condition that involves the collapse of the medial longitudinal arch of the foot during weight-bearing stress and the restoration of the arch after the removal of body weight.
Flatfoot may increase the load of the foot structure, potentially interfering with normal foot function. With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot, pain in the plantar foot, and instability of the medial foot structure. Treatment effect of corrective shoes or insoles on flexible flatfoot in children remain uncertain.
In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.
The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children presenting symptomatic flexible flatfoot only
排除标准
- •Children with a history of foot injury or surgery, foot abnormalities or a confirmed diagnosis such as neurological deficits.
研究组 & 干预措施
arch insole
Half of the subjects are randomly assigned to assess balance capacity with arch insole first.
Three day wash out, the subjects are assess balance capacity with sham insole.
干预措施: arch insole and sham insole (Device)
sham insole
Half of the subjects are randomly assigned to assess balance capacity with sham insole first.
Three day wash out, the subjects are assess balance capacity with arch insole.
干预措施: arch insole and sham insole (Device)
结局指标
主要结局
Change in Functional Reach Test(FRT) from pre to post-intervention.
时间窗: up to 10 minutes
The Functional Reach Test (FRT) is a quick screen for determining balance capacity.
Pediatric Berg Balance Scale
时间窗: up to 30 minutes
Pediatric Berg Balance Scale was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. Maximum score is 56 ,and minimum values is 0. Score 54-56 means a better outcome.
次要结局
- Change in Center of pressure (CoP) from pre to post-intervention.(up to 30 minutes)