Clinical trial NCT05456737: Functional Assessment in Children With Clubfoot
Official title: Investigation of Ankle-Foot Characteristics, Balance, Funtional Activity and Quality of Life in Children With Idiopatic Pes Equinovarus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clubfoot
Keywords: Balance
Disability
Foot anthropometry
Pes eqinovarus
Quality of life
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 51
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clubfoot groups: Diagnosed with idiopathic unilateral and bilateral clubfoot

Healty group : To be called "healthy" who continue their normal developmental stages and not diagnosed with orthopedic disease.

Brief summary: 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.

Detailed description: 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.

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.

While performing the statistical analysis of the data and creating the table, the affected foot was defined as the 'inferior' (inf) and the unaffected-contralateral foot as the 'superior' (sup) foot, considering the Dimeglio scores for the superior and inferior foot determination for the unilateral group (UG).

In the bilateral group (BG) and the healthy group (SG), the foot on the side on which they wrote (dominant hand) was called 'superior' and the non-dominant side was called 'inferior', since there was no difference between the Dimeglio scores of the children in both feet.

Eligibility criteria: Inclusion Criteria:

1. 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
2. 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: OxAFQ-C and OxAFQ-P
timeFrame: January 2020 - February 2021
Secondary outcomes:
measure: Foot lenght
timeFrame: January 2020 - February 2021
measure: Forefoot width
timeFrame: January 2020 - February 2021
measure: Heel width
timeFrame: January 2020 - February 2021
measure: Medial malleol-navicular distance
timeFrame: January 2020 - February 2021
measure: Intermalleolar distance
timeFrame: January 2020 - February 2021
measure: Leg circumference
timeFrame: January 2020 - February 2021
measure: FPI-6
timeFrame: January 2020 - February 2021
measure: Fizyosoft Balance System
timeFrame: January 2020 - February 2021
measure: Functional Activity and Skills Form
timeFrame: January 2020 - February 2021
measure: Kiddy-Kid-Kiddo KINDL
timeFrame: January 2020 - February 2021
measure: Dimeglio Scoring System
timeFrame: January 2020 - February 2021
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dilbade Special Education and Rehabilitation Center
state: Eyüp
Study officials:
affiliation: Medipol University
name: Özlem Aydın, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Devrim Tarakçı, Assoc. Prof.
role: STUDY_DIRECTOR
References:
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citation: Zapata KA, Karol LA, Jeans KA, Jo CH. Gross Motor Function at 10 Years of Age in Children With Clubfoot Following the French Physical Therapy Method and the Ponseti Technique. J Pediatr Orthop. 2018 Oct;38(9):e519-e523. doi: 10.1097/BPO.0000000000001218.
citation: Andriesse H, Westbom L, Hagglund G. Motor ability in children treated for idiopathic clubfoot. A controlled pilot study. BMC Pediatr. 2009 Dec 15;9:78. doi: 10.1186/1471-2431-9-78.
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citation: Loof E. Additional challenges in children with idiopathic clubfoot: is it just the foot? J Child Orthop. 2019 Jun 1;13(3):245-251. doi: 10.1302/1863-2548.13.190076.