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临床试验/NCT07244172
NCT07244172招募中不适用

Effects of Mud-walk on Foot Posture and Balance in Children With Flexible Flatfeet

Riphah International University2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2025年10月22日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
37
试验地点
2
主要终点
Foot Posture Index-6 (FPI-6)

研究概览

简要总结

The study will be a quasi-experimental study with a pre-post study design. 37 children with bilateral flexible flatfeet of age 6-11 years will be recruited by non-probability convenience sampling with pre and post assessment. The navicular height, foot posture, balance and functional performance of lower limb will be assessed through Navicular Drop Test, Foot Posture Index-6, Pediatric Berg Balance Scale and Single Leg Hop Test respectively. All recruited children will receive intervention for 30 minutes a day for 3 days a week for total 6 weeks. The exercise program will include warm up phase, walk on mud and cool down phase. Data will be analyzed through SPSS version 27.0.

详细描述

Flatfeet is one of the predominant conditions of feet in children and is characterized by absence of medial longitudinal arch. Flatfeet affect the foot posture by altering the entire biomechanics of musculoskeletal system of lower limb. It ultimately affects the balance and functional mobility in children and may have poor quality of life in adulthood. The strength training programs and uneven surfaces have been used previously for its intervention. The mud-walk provides natural resistance along with sensory feedback due to its soft, variable surface. The aim of this study is to determine effects of mud-walk on foot posture, balance and functional performance of lower limb in children with flexible flatfeet.

The study will be a quasi-experimental study with a pre-post study design. 37 children with bilateral flexible flatfeet of age 6-11 years will be recruited by non-probability convenience sampling with pre and post assessment from Presentation Convent High School and The Sanai School Sargodha. All children will be assessed for inclusion and exclusion. The navicular height, foot posture, balance and functional performance of lower limb will be assessed through Navicular Drop Test, Foot Posture Index-6, Pediatric Berg Balance Scale and Single Leg Hop Test respectively. All recruited children will receive intervention for 30 minutes a day for 3 days a week for total 6 weeks. The exercise program will include warm up phase, walk on mud and cool down phase. Data will be analyzed through SPSS version 27.0.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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 with bilateral flexible flat feet
  • Children aged 6-11 years
  • Children who are not involved in any other trial
  • FPI-6 score >6

排除标准

  • Children with rigid flatfeet
  • Prior foot or ankle surgery
  • Pain in lower extremities
  • Overweight or obese
  • Any other foot deformities
  • Any neurological or neuromuscular disorder

结局指标

主要结局

Foot Posture Index-6 (FPI-6)

时间窗: Baseline and 6th week

FPI-6 is a clinical tool for quantifying foot positioning that uses established criteria. The FPI consists of the following six items, each graded on a scale of -2 to +2 referring to the position of the forefoot, midfoot and hindfoot, and the three planes of motion: 1. talar head palpation; 2. symmetry of supra and infra lateral malleolar curvature; 3. inversion/eversion of the calcaneus; 4. prominence in the region of the talus-navicular joint; 5. height of the medial longitudinal arch; 6. abduction/adduction of the forefoot. The FPI thus obtained ranges from -12 (highly supinated) to +12 (highly pronated). It can be * highly pronated (+10 to +12) * pronated (+6 to +9) * normal (0 to +5) * supinated (-1 to -4) * highly supinated (-5 to -12). FPI-6 demonstrates a perfect weighted kappa value (Kw = 0.86), with a high intra-rater reliability (ICC = 0.96)

Navicular Drop Test (NDT)

时间窗: Baseline and 6th week

Navicular Drop Test is used to evaluate the amount of foot pronation. It is considered as a reliable and valid tool to measure static navicular height. The navicular height is measured while the child is sitting with barefoot flat on a platform with 90◦ knee flexion and the subtalar joint in neutral position. The Navicular drop is recorded as the difference in navicular height between subtalar joint neutral position and relaxed standing. Navicular drop more than 9 mm represented a pronated foot type, 5-9 mm a neutral foot and less than 5 mm a supinated foot. This test's intra-rater and inter-rater reliability has been demonstrated to range from 0.73 to 0.96 .

Pediatric Berg Balance Scale (PBBS)

时间窗: Baseline and 6th week

A 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population. Each item level scores range from 0-4 which is determined by the ability to perform the assessed activity. Maximum score = 56 points with 56 points being a perfect score. Test-retest (ICC2,1 = 0.923), interrater (ICC2,1 = 0.972), and intra-rater (ICC2,1 = 0.895-0.998) are reliabilities of PBS. It has high internal consistency (Cronbach α = 0.94) .

Foot Posture Index-6 (FPI-6)

时间窗: Baseline and 6th week

FPI-6 is a clinical tool for quantifying foot positioning that uses established criteria. The FPI consists of the following six items, each graded on a scale of -2 to +2 referring to the position of the forefoot, midfoot and hindfoot, and the three planes of motion: 1. talar head palpation; 2. symmetry of supra and infra lateral malleolar curvature; 3. inversion/eversion of the calcaneus; 4. prominence in the region of the talus-navicular joint; 5. height of the medial longitudinal arch; 6. abduction/adduction of the forefoot. The FPI thus obtained ranges from -12 (highly supinated) to +12 (highly pronated). It can be * highly pronated (+10 to +12) * pronated (+6 to +9) * normal (0 to +5) * supinated (-1 to -4) * highly supinated (-5 to -12). FPI-6 demonstrates a perfect weighted kappa value (Kw = 0.86), with a high intra-rater reliability (ICC = 0.96)

Navicular Drop Test (NDT)

时间窗: Baseline and 6th week

Navicular Drop Test is used to evaluate the amount of foot pronation. It is considered as a reliable and valid tool to measure static navicular height. The navicular height is measured while the child is sitting with barefoot flat on a platform with 90◦ knee flexion and the subtalar joint in neutral position. The Navicular drop is recorded as the difference in navicular height between subtalar joint neutral position and relaxed standing. Navicular drop more than 9 mm represented a pronated foot type, 5-9 mm a neutral foot and less than 5 mm a supinated foot. This test's intra-rater and inter-rater reliability has been demonstrated to range from 0.73 to 0.96 .

Pediatric Berg Balance Scale (PBBS)

时间窗: Baseline and 6th week

A 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population. Each item level scores range from 0-4 which is determined by the ability to perform the assessed activity. Maximum score = 56 points with 56 points being a perfect score. Test-retest (ICC2,1 = 0.923), interrater (ICC2,1 = 0.972), and intra-rater (ICC2,1 = 0.895-0.998) are reliabilities of PBS. It has high internal consistency (Cronbach α = 0.94) .

次要结局

  • Single Leg Hop Test(Baseline and 6th week)
  • Single Leg Hop Test(Baseline and 6th week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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