An observational study in Clubfoot, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 5 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-13.
Sponsored by Medipol University · Observational
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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.
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.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's enrollment of 51 is close to the median of 55 across 27 observational studies indexed under Clubfoot.
Browse Clubfoot studies →Medipol University is the lead sponsor of 326 studies on the registry; 86 are open to participants now.
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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.
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For the Healty group (control)
For the Pes Equinovarus groups:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with a diagnosis of unilateral clubfoot treated with the Ponseti method were evaluated once with the following evaluation methods: Anthropometric measurements FPI-6 Fizyosoft Balance System Functional Activity and Skills Form. OxAFQ-C and OxAFQ-P Kiddy-Kid-Kiddo KINDL
Other: assessment
Participants with a diagnosis of bilateral clubfoot treated with the Ponseti method were evaluated once with the following evaluation methods: Anthropometric measurements FPI-6 Fizyosoft Balance System Functional Activity and Skills Form. OxAFQ-C and OxAFQ-P Kiddy-Kid-Kiddo KINDL
Other: assessment
Healthy participants with normal development were evaluated once with the following evaluation methods: Anthropometric measurements FPI-6 Fizyosoft Balance System Functional Activity and Skills Form. OxAFQ-C and OxAFQ-P Kiddy-Kid-Kiddo KINDL
Other: assessment
Application of various assessment methods to determine the foot characteristics, foot posture, functional activity, balance levels and quality of life of the determined groups.
OxAFQ-C and OxAFQ-P
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.
Time frame: January 2020 - February 2021
Foot lenght
The foot length was determined by taking the footprint on the paper and measuring the distance between the two extreme points on the paper with the help of a tape measure.
Time frame: January 2020 - February 2021
Forefoot width
Forefoot width, was determined by taking the footprint on the paper and measuring the distance between first and fifth metatarsal on the paper with the help of a tape measure.
Time frame: January 2020 - February 2021
Heel width
Heel width was determined by taking the footprint on the paper and measuring the distance between the two extreme points on heel with the help of a tape measure.
Time frame: January 2020 - February 2021
Medial malleol-navicular distance
Medial malleol-navicular distance were measured with the help of a tape measure.
Time frame: January 2020 - February 2021
Intermalleolar distance
Intermalleolar distance was determined by measuring the distance between the medial malleolus in both feet with the help of a tape measure in the standing position.
Time frame: January 2020 - February 2021
Leg circumference
Leg circumference was determined in a standing position by measuring the circumference of the thickest part of the leg with a tape measure.
Time frame: January 2020 - February 2021
FPI-6
It is a scale that determines foot posture by palpation method. Position of the head of the talus in the hindfoot, inclination under the lateral malleolus, inversion-eversion of the calcaneus; In the forefoot, the talonavicular joint area is evaluated against the medial longitudinal arch structure, and the abduction-adduction of the forefoot is scored between -2 and +2 points. * 2,-1 codes for supination of the foot, 0 for neutral, +1,+2 for pronation posture. It was used in this study to evaluate bilateral foot posture.
Time frame: January 2020 - February 2021
Fizyosoft Balance System
Fizyosoft Balance System, which was developed by engineers and physiotherapists within the scope of the Tübitak Project, is basically based on the principle of using the Nintendo WiiFit system through a computer by developing software for the purpose of objective balance assessment on the balance board. The developed system evaluates the person's static standing balance, load distributions in each foot, postural sway and proprioception. The main issues in the evaluation are the changes in the center of gravity in the x and y axes of the cases with eyes open and closed, the change in postural sway, and the position of the body center of gravity on the feet.In this study, it was used to evaluate static balance, proprioception, and load distribution and transfer in the feet.
Time frame: January 2020 - February 2021
Functional Activity and Skills Form
The form, which consists of parameters such as straight walking, toe walking, heel walking, running, squatting, standing on one foot and jumping on one foot, measures the ability of the ankle in functional activities. The scoring system is at the item and subgroup level and no total points are used. For each item, it ranges from 0 (severe reduction / no capacity) to 4 (within normal limits) according to the nature of the movement, and a high score reflects high function.
Time frame: January 2020 - February 2021
Kiddy-Kid-Kiddo KINDL
Kiddy-KINDL, Kid-KINDL and Kiddo-KINDL, which is used to evaluate general health-related quality of life in this study, are versions of general health-related quality of life, representing different age groups. The Kiddy-KINDL Junior Form is used for young children aged 4-7, the Kid-KINDL Child Form: for children aged 8-12, and the Kiddo-KINDL Adolescent Form is used for children aged 13-16. In scoring between 0-100, 0 indicates the worst score, while 100 indicates the best score. A high score is an indicator of good quality of life.
Time frame: January 2020 - February 2021
Dimeglio Scoring System
The scale developed by Dimeglio et al. measures the correctability of the foot angularly and determines the severity of the deformity. In this study, it was used to determine the severity of the deformity and to determine the superior-inferior foot according to the foot severity.
Time frame: January 2020 - February 2021
Plan to share: No
Ran from Jan 2020 to primary completion in Feb 2021, 13 months.
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