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

Not Applicable
Recruiting
Conditions
Club Foot
Interventions
Other: Three-Phase Physical Therapy Intervention
Registration Number
NCT06407739
Lead Sponsor
Riphah International University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
19
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
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Exclusion Criteria
  • Children who were diagnosed with arthrogryposis multiplex congentia
  • Children with spastic Equinovarus
  • Children who had multiple surgical operation
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Three-Phase Physical Therapy InterventionThree-Phase Physical Therapy InterventionThis group will be given the three-phase physical therapy intervention and each phase prolong for period of one month
Primary Outcome Measures
NameTimeMethod
One leg standing test for Functional ActivityBaseline and 12th Week

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

Sit to stand test for Functional ActivityBaseline and 12th Week

The number of bilateral squats completed in 60 s is recorded

Secondary Outcome Measures
NameTimeMethod
Pirani score for Clubfoot SeverityBaseline and 12th Week

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.

The oxford Ankle Foot questionnaire for children and parent for Functional StatusBaseline and 12th Week

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

Trial Locations

Locations (1)

pakistan Society for the Rehabilitaion of Disables

🇵🇰

Lahore, Punjab, Pakistan

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