Functional Assessment in Children With Clubfoot

NCT05456737 | Completed

• 1 other identifier: 10840098-604.01.01-E.1590 / 56
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Clubfoot

Keywords

Balance; Disability; Foot anthropometry; Pes eqinovarus; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Foot lenght

  January 2020 - February 2021

• Forefoot width

  January 2020 - February 2021

• Heel width

  January 2020 - February 2021

• Medial malleol-navicular distance

  January 2020 - February 2021

• Intermalleolar distance

  January 2020 - February 2021

Study Arms (3)

Unilateral Group

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

Bilateral Group

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

Healty Group (Control)

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

Interventions

assessment OTHER

Application of various assessment methods to determine the foot characteristics, foot posture, functional activity, balance levels and quality of life of the determined groups.

Bilateral Group; Healty Group (Control); Unilateral Group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Dilbade Special Education and Rehabilitation Center

Istanbul, Eyüp, 34050, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 29674653 BACKGROUND

• 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.

  PMID: 28574943 BACKGROUND

• 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.

  PMID: 25183601 BACKGROUND

• Garcia-Gonzalez 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.

  PMID: 31259147 BACKGROUND

• 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.

  PMID: 25458441 BACKGROUND

• 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. doi: 10.2106/00004623-200401000-00005.

  PMID: 14711941 RESULT

• 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.

  PMID: 29965933 RESULT

• 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.

  PMID: 20003483 RESULT

• Agarwal A, Rastogi A. Anthropometric measurements in Ponseti treated clubfeet. SICOT J. 2018;4:19. doi: 10.1051/sicotj/2018010. Epub 2018 May 25.

  PMID: 29806584 RESULT

• 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.

  PMID: 31312263 RESULT

Related Links

• journal
• journal

MeSH Terms

Conditions

Clubfoot

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Özlem Aydın, M.Sc.

  Medipol University

  PRINCIPAL INVESTIGATOR

• Devrim Tarakçı, Assoc. Prof.

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 13, 2022
• Study Start: January 15, 2020
• Primary Completion: February 26, 2021
• Study Completion: February 26, 2021
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)