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临床试验/NCT05456737
NCT05456737已完成不适用

Investigation of Ankle-Foot Characteristics, Balance, Funtional Activity and Quality of Life in Children With Idiopatic Pes Equinovarus

Medipol University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
OxAFQ-C and OxAFQ-P

研究概览

简要总结

The aim of this study was to determine ankle-foot characteristics, load distribution on foot, balance-proprioception, functional activity skills, disability and quality of life levels in children treated with Ponseti's method, finding out the asymetries between both feet in each group, to determine the differences between the healthy foot and the clubfeet, and also to examine the relationship between all parameters in healty children and children with clubfoot.

51 children ages ranging 5 to 15, were included in this study. In order to evaluate foot characteristics, anthropometric measurements were applied. FPI-6 is used for foot posture.Fizyosoft Balance System is used to measure the balance and proprioception. Functional activity were evaluated with Functional Activity and Skills Form. Disability were evaluated with OxAFQ-C and OxAFQ-P and KINDL forms are used to assess quality of life.

详细描述

Pes Equinovarus (PEV) is one of the complex pediatric foot deformities that has a prevalence of 1-2/1000 live births and requires intensive treatment. The majority of patients with clubfeet have the idiopathic form. Men have a higher risk of exposure with a rate of 2-4/1000 compared to women, and bilateral involvement is present in half of the patients. Each child can be affected at different levels according to their mobility and morphological characteristics. The shape and function of the foot are greatly affected by the four components (CAVE) as adductus in the forefoot, cavus in the midfoot, varus in the hindfoot and equinus deformity in the ankle that make up the complex structure of the disease. It has been reported that children with Pes Equinovarus may experience problems with balance-coordination, gross motor skills and muscle strength due to the complex nature of the disease and an unsuccessful treatment, and also their quality of life may be adversely affected due to difficulties in daily activities.

Treatment of the disease is basically in two ways: operative and/or non-operative (conservative). The main goals of both treatments are to improve the mobility of the foot by correcting the four orthopedic deformities that constitute the complex nature of the disease, and to create a functional, painless, full contact with the ground and not needing modified shoes. The Ponseti method, which is one of the conservative treatment methods that is gold standart for the treatment of clubfoot, is a multi-stage method that requires gentle manipulation, weekly serial casting with a special technique, Achilles tenotomy if necessary, and the use of foot abduction orthosis after casting.

Although the clinical and functional results after Ponseti treatment were promising, deviations in plantar pressure distribution were found as a result of pedobarographic measurements and gait analyzes in unilateral and bilateral feet. It was stated that the dimensions of the unilateral foot were smaller than the contralateral foot, and it was stated that the contralateral foot could have different sizes compared to the normally developing foot. There is no definite judgment about foot anthropometry, due to the existence of studies stating that the sizes of the affected and contra-lateral feet are similar in unilateral involvement.

Balance is another parameter that is stated to be negatively affected depending on foot involvement and the severity of the deformity, but studies examining balance and activity-participation levels are very limited.In addition to studies stating that there is a difference in foot-ankle characteristics, plantar pressure distribution and gross motor skills in children who have received Ponseti treatment, there are also studies stating the opposite. The number of studies on activities of daily living and quality of life is quite limited, and there was any study examining balance and proprioception according to unilateral and bilateral involvement.

For this reason, the aim of this study was to compare the foot-ankle characteristics, plantar pressure distribution, functional activity skills, disability, quality of life and balance-proprioception levels in children treated with the Ponseti method primarily with unilateral-bilateral involvement as well as with children who maintain normal development. To examine the relationship between balance-proprioception involvement and functional activity skills, disability and quality of life in children with clubfoot.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • For the Healty group (control)
  • To be volunteer
  • Being between the ages of 5-15
  • Having signed the informed consent form
  • To be approved by the orthopedist that he does not have any orthopedic problems that would prevent walking, balance and activities of daily living, especially standing
  • Not having any neurological disorders
  • For the Pes Equinovarus groups:
  • To be volunteer
  • Being between the ages of 5-15
  • Having signed the informed consent form
  • To be diagnosed with idiopathic pes equinovarus
  • Being treated primarily with the Ponseti method
  • Being able to stand without support
  • Being able to walk without an assistive device

排除标准

  • Having a diagnosis of neurologic clubfoot
  • clubfoot associated with severe syndromes such as myelomeningocele or Down syndrome, Larsen, Diastrophic Dysplasia
  • Diagnosing congenital joint contractures such as Arthrogryposis Multiplex Congenita
  • To have an operative treatment for Pes Echinovarus in the last 1 year
  • Refusing to participate in the study

结局指标

主要结局

OxAFQ-C and OxAFQ-P

时间窗: January 2020 - February 2021

The Oxford Ankle-Foot Questionnaire child and parent form (OxAFQ-C and OxAFQ-P) was used to assess disability severity and function associated with foot-ankle problems. Response options for each item were rated from never (4), rarely (3), sometimes (2), very often (1) to always (0), indicating how often the problem affected the child. Scoring on the 4-field scale is calculated by converting the sum of the field scores to each field's percentage scale (0-100). A higher score for an area represents better function.

次要结局

  • Medial malleol-navicular distance(January 2020 - February 2021)
  • Heel width(January 2020 - February 2021)
  • Dimeglio Scoring System(January 2020 - February 2021)
  • Foot lenght(January 2020 - February 2021)
  • Forefoot width(January 2020 - February 2021)
  • Leg circumference(January 2020 - February 2021)
  • Fizyosoft Balance System(January 2020 - February 2021)
  • FPI-6(January 2020 - February 2021)
  • Kiddy-Kid-Kiddo KINDL(January 2020 - February 2021)
  • Intermalleolar distance(January 2020 - February 2021)
  • Functional Activity and Skills Form(January 2020 - February 2021)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Aydın

Physiotherapist

Medipol University

研究点 (1)

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