ClubfootNCT05456737
Functional Assessment in Children With Clubfoot
An observational study of Clubfoot, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Clubfoot
- What is being tested?
- assessment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2020to 26 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dilbade Special Education and Rehabilitation Center
Istanbul, Eyüp, 34050
About this study
Official title: Investigation of Ankle-Foot Characteristics, Balance, Funtional Activity and Quality of Life in Children With Idiopatic Pes Equinovarus
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.
Read the 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.
- Conditions
- Clubfoot
- Being tested
- assessment
- Keywords
- Balance, Disability, Foot anthropometry, Pes eqinovarus, Quality of life
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentOther
Application of various assessment methods to determine the foot characteristics, foot posture, functional activity, balance levels and quality of life of the determined groups.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 2020 - February 2021
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: January 2020 - February 2021
Medial malleol-navicular distance
Medial malleol-navicular distance were measured with the help of a tape measure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: January 2020 - February 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start15 Jan 2020
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ClubfootStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Aydın, Medipol University
- Investigators
- Özlem Aydın, M.Sc., Principal investigator, Medipol UniversityDevrim Tarakçı, Assoc. Prof., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456737
- Sponsor's protocol ID
- 10840098-604.01.01-E.1590 / 56
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29674653Sangiorgio 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.
PubMed 28574943Gelfer 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.
PubMed 25183601Garcia-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.
PubMed 31259147Cosma 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.
PubMed 25458441Dobbs 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.
PubMed 14711941Zapata 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.
PubMed 29965933Andriesse 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.
PubMed 20003483Agarwal A, Rastogi A. Anthropometric measurements in Ponseti treated clubfeet. SICOT J. 2018;4:19. doi: 10.1051/sicotj/2018010. Epub 2018 May 25.
PubMed 29806584Loof 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.
PubMed 31312263
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Ankle-Foot Characteristics, Balance, Funtional Activity and Quality of Life in Children With Idiopatic Pes Equinovarus
- ClinicalTrials.gov ID
- NCT05456737
- Acronym / sponsor ID
- 10840098-604.01.01-E.1590 / 56
- Conditions
- Clubfoot
- Keywords
- Balance, Disability, Foot anthropometry, Pes eqinovarus, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral Group | – | Other: assessmentParticipants 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 |
| Bilateral Group | – | Other: assessmentParticipants 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 |
| Healty Group (Control) | – | Other: assessmentHealthy 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 |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (14 listed)
- For the Healty group (control)
- For the Pes Equinovarus groups:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessmentApplication of various assessment methods to determine the foot characteristics, foot posture, functional activity, balance levels and quality of life of the determined groups. | Other | Bilateral Group, Healty Group (Control), Unilateral Group |
Primary outcome
OxAFQ-C and OxAFQ-P
Time frame: 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.
11 secondary outcomes
Foot lenght
Time frame: January 2020 - February 2021
Forefoot width
Time frame: January 2020 - February 2021
Heel width
Time frame: January 2020 - February 2021
Medial malleol-navicular distance
Time frame: January 2020 - February 2021
Intermalleolar distance
Time frame: January 2020 - February 2021
Leg circumference
Time frame: January 2020 - February 2021
FPI-6
Time frame: January 2020 - February 2021
Fizyosoft Balance System
Time frame: January 2020 - February 2021
Functional Activity and Skills Form
Time frame: January 2020 - February 2021
Kiddy-Kid-Kiddo KINDL
Time frame: January 2020 - February 2021
Dimeglio Scoring System
Time frame: January 2020 - February 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Background: PubMed 29674653Xu 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.
- Background: PubMed 28574943Sangiorgio 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.
- Background: PubMed 25183601Gelfer 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.
- Background: PubMed 31259147Garcia-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.
- Background: PubMed 25458441Cosma 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.
- Results publication: PubMed 14711941Dobbs 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.
- Results publication: PubMed 29965933Zapata 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.
- Results publication: PubMed 20003483Andriesse 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.
- Results publication: PubMed 29806584Agarwal A, Rastogi A. Anthropometric measurements in Ponseti treated clubfeet. SICOT J. 2018;4:19. doi: 10.1051/sicotj/2018010. Epub 2018 May 25.
- Results publication: PubMed 31312263Loof 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.
- journalLink provided by the sponsor.
- journalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Aydın, M.Sc. principal investigator
Medipol University
Devrim Tarakçı, Assoc. Prof. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OxAFQ-C and OxAFQ-P (time frame: January 2020 - February 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05456737, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.