Clubfoot Clinical Trial
Official title:
Investigation of Ankle-Foot Characteristics, Balance, Funtional Activity and Quality of Life in Children With Idiopatic Pes Equinovarus
Verified date | July 2022 |
Source | Medipol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 51 |
Est. completion date | February 26, 2021 |
Est. primary completion date | February 26, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 15 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Dilbade Special Education and Rehabilitation Center | Istanbul | Eyüp |
Lead Sponsor | Collaborator |
---|---|
Medipol University |
Turkey,
Agarwal A, Rastogi A. Anthropometric measurements in Ponseti treated clubfeet. SICOT J. 2018;4:19. doi: 10.1051/sicotj/2018010. Epub 2018 May 25. — View Citation
Andriesse H, Westbom L, Hägglund 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. — View Citation
Cosma D, Vasilescu DE. A Clinical Evaluation of the Pirani and Dimeglio Idiopathic Clubfoot Classifications. J Foot Ankle Surg. 2015 Jul-Aug;54(4):582-5. doi: 10.1053/j.jfas.2014.10.004. Epub 2014 Nov 13. — View Citation
Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, Gurnett CA. Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet. J Bone Joint Surg Am. 2004 Jan;86(1):22-7. — View Citation
García-González NC, Hodgson-Ravina J, Aguirre-Jaime A. Functional physiotherapy method results for the treatment of idiopathic clubfoot. World J Orthop. 2019 Jun 18;10(6):235-246. doi: 10.5312/wjo.v10.i6.235. eCollection 2019 Jun 18. — View Citation
Gelfer Y, Dunkley M, Jackson D, Armstrong J, Rafter C, Parnell E, Eastwood DM. Evertor muscle activity as a predictor of the mid-term outcome following treatment of the idiopathic and non-idiopathic clubfoot. Bone Joint J. 2014 Sep;96-B(9):1264-8. doi: 10.1302/0301-620X.96B9.33755. — View Citation
Lööf 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. — View Citation
Sangiorgio SN, Ebramzadeh E, Morgan RD, Zionts LE. The Timing and Relevance of Relapsed Deformity in Patients With Idiopathic Clubfoot. J Am Acad Orthop Surg. 2017 Jul;25(7):536-545. doi: 10.5435/JAAOS-D-16-00522. — View Citation
Xu C, Wei J, Yan YB, Shang L, Yang XJ, Huang LY, Lei W. Pedobarographic Analysis following Ponseti Treatment for Unilateral Neglected Congenital Clubfoot. Sci Rep. 2018 Apr 19;8(1):6270. doi: 10.1038/s41598-018-24737-w. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
January 2020 - February 2021 | |
Secondary | 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. | January 2020 - February 2021 | |
Secondary | 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. | January 2020 - February 2021 | |
Secondary | 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. | January 2020 - February 2021 | |
Secondary | Medial malleol-navicular distance | Medial malleol-navicular distance were measured with the help of a tape measure. | January 2020 - February 2021 | |
Secondary | 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. | January 2020 - February 2021 | |
Secondary | 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. | January 2020 - February 2021 | |
Secondary | 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. |
January 2020 - February 2021 | |
Secondary | 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. |
January 2020 - February 2021 | |
Secondary | 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. | January 2020 - February 2021 | |
Secondary | 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. |
January 2020 - February 2021 | |
Secondary | 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. |
January 2020 - February 2021 |
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