Effects of Custom Fitted Supportive Socks With Integrated Insoles in Individuals With Flat Feet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Navicular Drop Test (NDT)
研究概览
简要总结
The goal of this clinical trial is to test if wearing custom-fitted supportive socks with built-in insoles, along with a foot exercise program, can improve foot posture, The goal of this clinical trial is to evaluate whether wearing custom-fitted supportive socks with built-in insoles, along with a foot exercise program, can improve foot posture, walking ability, and foot comfort in children aged five to twelve years with flexible flat feet.
The main questions this study aims to answer are:
Does the use of supportive socks with insoles and exercises improve foot posture and the shape of the foot arch? Does this combined approach improve walking ability and overall foot comfort? Researchers will compare children who wear supportive socks with built-in insoles and perform exercises to children who perform the same exercise program without the supportive socks to see which approach is more effective.
Participants will:
Wear the assigned supportive socks for 6-8 hours each day during daily activities if allocated to the socks group.
Perform foot exercises with a physical therapist for six weeks. Take part in assessments of foot posture, walking ability, and foot comfort at the start and after six weeks Data collection is currently in progress. The findings of this study may help support non-surgical treatment options for children with flexible flat feet.
详细描述
This randomized controlled trial is being conducted to evaluate the effectiveness of custom-fitted supportive socks with integrated insoles combined with a comprehensive exercise program in individuals with flexible flat feet. Participants are being randomly allocated into two groups: the intervention group receives both the supportive socks with integrated insoles and an exercise program, while the control group receives the exercise program alone. The primary aim of the study is to determine the intervention's impact on postural alignment, functional mobility, and foot health. A single-blind design is being employed, with the outcome assessor blinded to group allocation. This trial aims to generate evidence regarding the use of custom-fitted supportive socks with integrated insoles in conjunction with exercises for the conservative management of flexible flat feet.
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
Single-blind design: The outcome assessor was blinded to the group allocation to reduce measurement bias. Participants were not blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 5 to 12 years
- •Both Gender.
- •With Flexible flat feet.
- •Positive navicular drop test
- •Positive too many toes test, toe raising test and medial longitudinal arch angle
排除标准
- •Any congenital deformity of the lower limb
- •Any recent injuries
- •Any recent surgeries
- •Any neurological deficit
- •Body Mass Index (BMI)≥25
结局指标
主要结局
Navicular Drop Test (NDT)
时间窗: Baseline
The Navicular Drop Test assesses postural alignment by measuring the height difference of the navicular bone between the non-weight-bearing and weight-bearing positions. It evaluates medial arch collapse and foot pronation. Higher values = greater navicular drop → poorer postural alignment / more pronation, Lower value = better arch stability.
Navicular Drop Test (NDT)
时间窗: 6 weeks after intervention
The Navicular Drop Test assesses postural alignment by measuring the height difference of the navicular bone between the non-weight-bearing and weight-bearing positions. It evaluates medial arch collapse and foot pronation. Higher values = greater navicular drop → poorer postural alignment / more pronation, Lower value = better arch stability.
次要结局
- Medial Longitudinal Arch Angle (MLAA)(Baseline)
- Medial Longitudinal Arch Angle (MLAA)(6 weeks after intervention)
- Timed Up and Go Test (TUG)(Baseline)
- Timed Up and Go Test (TUG)(6 weeks after intervention)
- Six-Minute Walk Test (6MWT)(Baseline)
- Six-Minute Walk Test (6MWT)(6 weeks after intervention)
- Foot Function Index (FFI)(Baseline)
- Foot Function Index (FFI)(6 weeks after intervention)
- Foot Health Status Questionnaire (FHSQ)(Baseline)
- Foot Health Status Questionnaire (FHSQ)(6 weeks after intervention)