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

NCT06407739 | Completed

• 1 other identifier: REC/RCR & AHS/23/0770
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Club Foot

Keywords

Club foot; Ponseti technique; Three-phase physical therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pirani score for Clubfoot Severity

  Baseline and 12th Week

• The oxford Ankle Foot questionnaire for children and parent for Functional Status

  Baseline and 12th Week

Study Arms (1)

Three-Phase Physical Therapy Intervention

EXPERIMENTAL

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

Interventions

Three-Phase Physical Therapy Intervention OTHER

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

Three-Phase Physical Therapy Intervention

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

pakistan Society for the Rehabilitaion of Disables

Lahore, Punjab Province, 05308, Pakistan

Location

Related Publications (4)

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

  BACKGROUND

• 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.

  PMID: 32379245 BACKGROUND

• 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.

  PMID: 34583148 BACKGROUND

• 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.

  PMID: 34423014 BACKGROUND

MeSH Terms

Conditions

Clubfoot

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

Study Officials

• Fareeha Kausar

  Riphah International University, Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 15, 2024
• Primary Completion: August 5, 2024
• Study Completion: September 15, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)