Clinical trial NCT06407739: Three Phase Physical Therapy in Children With Relapsed Club Foot After Ponseti Treatment
Official title: Effects of Three Phase Physical Therapy on Functional Activity in Children With Relapsed Club Foot After Ponseti Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Club Foot
Keywords: Club foot
Ponseti technique
Three-phase physical therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 19
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clubfoot, or congenital Talipes Equinovarus (CTEV), is a condition where a baby is born with one or both feet twisted inward and downward due to abnormal fetal foot development. Its estimated global prevalence is 1 in 1,000 live births, varying across populations. Relapsed clubfoot, a recurrence after initial correction, may occur due to incomplete treatment, noncompliance, muscle imbalance, or natural growth. Treatment involves surgical and non-surgical interventions, including soft tissue releases, osteotomies, and external fixation devices. The Ponseti method, a non-surgical approach, is commonly used in infants, with post-treatment physiotherapy focusing on three phases to optimize foot function. This holistic approach aims to achieve the best long-term outcomes for children with clubfoot. This 6-month randomized clinical trial at PSRD Hospital aims to assess the effectiveness of three-phase physical therapy versus conventional physiotherapy in treating clubfoot. With a sample size of 19 participants and a 10% attrition rate, the study involves children aged 3-10 previously treated with the Ponseti method. Data collection includes, one-leg standing and sit-to stand tests, Pirani score and the Oxford Ankle Foot Questionnaire. The three-phase therapy consists of joint mobilization, kinesio taping, and functional exercises over three months, with a focus on improving balance and proprioception.


Eligibility criteria: Inclusion Criteria:

* Having unilateral and bilateral club foot
* Age between 3-10 year
* Previously treated with Ponseti method
* Children fall under Grade II and III according to classification of relapse pattern

Exclusion Criteria:

* Children who were diagnosed with arthrogryposis multiplex congentia
* Children with spastic Equinovarus
* Children who had multiple surgical operation

Primary outcomes:
measure: One leg standing test for Functional Activity
timeFrame: Baseline and 12th Week
measure: Sit to stand test for Functional Activity
timeFrame: Baseline and 12th Week
Secondary outcomes:
measure: Pirani score for Clubfoot Severity
timeFrame: Baseline and 12th Week
measure: The oxford Ankle Foot questionnaire for children and parent for Functional Status
timeFrame: Baseline and 12th Week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: pakistan Society for the Rehabilitaion of Disables
state: Punjab
Study officials:
affiliation: Riphah International University, Lahore, Pakistan
name: Fareeha Kausar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bent MA. Congenital Talipes Equinovarus (Clubfoot). Orthopaedics for the Newborn and Young Child: A Practical Clinical Guide: Springer; 2023. p. 47-60.
citation: Novotny T, Eckhardt A, Knitlova J, Doubkova M, Ostadal M, Uhlik J, Musilkova J. Increased Microvessel and Arteriole Density in the Contracted Side of the Relapsed Clubfoot. J Pediatr Orthop. 2020 Nov/Dec;40(10):592-596. doi: 10.1097/BPO.0000000000001563.
citation: Grin L, van der Steen MC, Wijnands SDN, van Oorschot L, Besselaar AT, Vanwanseele B. Forefoot adduction and forefoot supination as kinematic indicators of relapse clubfoot. Gait Posture. 2021 Oct;90:415-421. doi: 10.1016/j.gaitpost.2021.09.185. Epub 2021 Sep 20.
citation: Masrouha K, Chu A, Lehman W. Narrative review of the management of a relapsed clubfoot. Ann Transl Med. 2021 Jul;9(13):1102. doi: 10.21037/atm-20-7730.