Three Phase Physical Therapy in Children With Relapsed Club Foot After Ponseti Treatment

Effects of Three Phase Physical Therapy on Functional Activity in Children With Relapsed Club Foot After Ponseti Treatment

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.

Study Overview

• Status: Completed
• Conditions: Club Foot
• Intervention / Treatment: Other: Three-Phase Physical Therapy Intervention

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 05308
      • pakistan Society for the Rehabilitaion of Disables

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Three-Phase Physical Therapy Intervention; This group will be given the three-phase physical therapy intervention and each phase prolong for period of one month

Other: Three-Phase Physical Therapy Intervention; Phase 1: It include subtalar and talocrural joint mobilization in the supine position along with stretching and home education Stage 2: It include subtalar and talocrural joint mobilization in the supine position along with Kinesiotaping and functional exercises Phase 3: this phase include balance and propioceptive training aling with along with strengthening exercises of peroneal and tibialis anterior

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One leg standing test for Functional Activity	The one leg standing test is considered to be potentially useful for predicting functional deterioration. In the present study, we used the one leg standing test in the eyes open condition. The reliability of the SLS test is 0.89 and 0.86 with eyes opene	Baseline and 12th Week
Sit to stand test for Functional Activity	The number of bilateral squats completed in 60 s is recorded	Baseline and 12th Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pirani score for Clubfoot Severity	PirS assesses six clinical signs characterizing clubfoot, three items for the midfoot, and three for the Hindfoot: medial crease (MC-Pir), lateral part of the head of the talus, the curvature of the lateral border, posterior crease, empty heel, and rigid equinus. Each of the six items are scored on a three-point scale (0 = none, 0.5 = moderate, 1 = severe abnormality). The total score ranges from 0 to 6 based on the severity of the deformity of the examined foot.	Baseline and 12th Week
The oxford Ankle Foot questionnaire for children and parent for Functional Status	OxAFQ is a child or parent-reported (or caregiver) self-report health status questionnaire. (The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) - A Guide to the Scoring System, Oxford University Innovation Limited 2011). In this study, children and their parents were individually questioned	Baseline and 12th Week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Fareeha Kausar, Riphah International University, Lahore, Pakistan

Publications and helpful links

General Publications

• Bent MA. Congenital Talipes Equinovarus (Clubfoot). Orthopaedics for the Newborn and Young Child: A Practical Clinical Guide: Springer; 2023. p. 47-60.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): August 5, 2024
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Club foot; Ponseti technique; Three-phase physical therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities, Acquired; Foot Deformities, Congenital; Talipes; Foot Deformities; Clubfoot; Equinus Deformity
• Other Study ID Numbers: REC/RCR & AHS/23/0770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No