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临床试验/NCT06955039
NCT06955039已完成不适用

Effects of Sand Exercise Program On Foot Posture , Navicular Drop and Dynamic Balance in Children With Pronated Foot

Riphah International University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Feiss line Test

研究概览

简要总结

This randomized controlled trial investigates the effects of combining sand training with navicular drop interventions on foot posture and dynamic balance in children aged 6-11 with pronated feet. Pronated foot posture, marked by inward foot rolling and a lowered arch, can impair gait and balance. Early intervention is key to preventing long-term issues. Twenty participants will be divided into experimental and control groups. Over eight weeks, the experimental group will perform sand and towel curl exercises, while the control group will do towel curls only. Foot posture, navicular drop, and balance will be assessed using the FPI-6, Navicular Drop Test, Y Balance Test, and Feiss Line Test at baseline, 4 weeks, and 8 weeks. The study aims to evaluate the added benefits of sand training in improving pediatric foot health.

详细描述

The effects of sand training exercises combined with navicular drop interventions on dynamic balance and foot posture in children aged 6 to 11 years with pronated feet. Pronated foot posture, characterized by the inward rolling of the foot and a lowered medial arch, is prevalent in pediatric populations and can lead to altered gait mechanics and reduced dynamic balance. Early intervention is crucial to prevent long-term deformities and improve overall foot health. The study aims to provide evidence-based insights into the benefits of integrating proprioceptive training with specific sand exercises program targeting the navicular bone, thereby enhancing foot posture and dynamic balance in affected children.

This randomized controlled trial (RCT) will involve 20 participants divided into an experimental group and a control group to assess the effects of an 8-week exercise program on foot health in children with pronated feet. The experimental group will perform sand activities and towel curl exercises three times a week, while the control group will only perform towel curl exercises. The study will measure foot posture, navicular drop, and dynamic balance using the Foot Posture Index (FPI-6), Navicular Drop Test, Y Balance Test, and Feiss Line Test, with assessments conducted at baseline, 4 weeks, and 8 weeks post-intervention. This study aims to provide evidence on the effects of combining sand training with towel curl exercises for determining foot posture.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged [6-11] years with bilateral pronated feet.
  • Both gender
  • No recent foot injury or lower extremity pain from last six months
  • Has no history of foot and ankle surgery lifetime
  • All eligible children were assessed with the Feiss line method

排除标准

  • the presence of pain in the foot at the time of physical examination
  • injury to the lower limbs, such as musculoskeletal injuries, during the previous 6 months congenital structural abnormalities, cerebral palsy, motor dysfunction prior surgery affecting the foot

研究组 & 干预措施

Group A

Experimental

Clinical experimental: For group A each session last 50 minutes daily for 8 weeks 3 times per week during a 8-week period

干预措施: Sand Activites (Other)

Group A

Experimental

Clinical experimental: For group A each session last 50 minutes daily for 8 weeks 3 times per week during a 8-week period

干预措施: Towel Curl Exercises (Other)

Group B

Active Comparator

Clinical experimental: For group B each session lasted for 5 minutes. The exercise was performed in three sets per week, with each set lasting 5 minutes. Participants performed the exercise 20-25 times for 8 weeks

干预措施: Sand Activites (Other)

Group B

Active Comparator

Clinical experimental: For group B each session lasted for 5 minutes. The exercise was performed in three sets per week, with each set lasting 5 minutes. Participants performed the exercise 20-25 times for 8 weeks

干预措施: (TCE) (Other)

结局指标

主要结局

Feiss line Test

时间窗: base line ,4th week ,8th week

The Feiss Line Test assesses the medial longitudinal arch by drawing a line from the medial malleolus to the first metatarsophalangeal joint. The navicular tuberosity should lie on or near this line; displacement below indicates arch lowering. A perpendicular distance from the navicular to this line is measured-positive if above, negative if below. The test shows high reliability, with inter-tester ICC of 0.94 and intra-tester ICC of 0.91, indicating consistent measurements across and within testers.

Foot Posture Index (FPI -6 )

时间窗: base line ,4th week ,8th week

Foot posture is assessed using the Foot Posture Index (FPI-6) with the subject barefoot in a relaxed standing position. It evaluates six criteria across the forefoot, midfoot, and hindfoot, including talar head palpation, malleolar curvature, calcaneal position, talonavicular prominence, medial arch height, and forefoot alignment. Scores range from -12 (highly supinated) to +12 (highly pronated). The FPI-6 is a quick, simple, and reliable tool, showing strong intra-rater reliability (ICC 0.81-0.92) and good inter-rater reliability (ICC 0.69), especially in pediatric assessments.

Navicular Drop Measurement

时间窗: base line ,4th week ,8th week

The Navicular Drop Test (NDT) measures foot pronation by comparing navicular height in a seated subtalar neutral position to its height in relaxed standing. It shows moderate to good intra-rater reliability, with ICC values ranging from 0.61 to 0.79, making it a useful clinical tool for assessing pronation

Dynamic Balance Assessment

时间窗: base line ,4th week ,8th week

The Star Balance Test (or Y-Balance Test) assesses dynamic balance by having participants reach in three directions-anterior, posteromedial, and posterolateral-while balancing on one foot. The test is performed clockwise for the right foot and counterclockwise for the left. Reach distance is recorded, and errors require a retest. It shows good interrater reliability with ICC values of 0.80-0.85 and a standard error of 3.1-4.2 cm.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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