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Clinical Trials/NCT06407739
NCT06407739
Completed
Not Applicable

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

Riphah International University1 site in 1 country19 target enrollmentMay 15, 2024
ConditionsClub Foot

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Club Foot
Sponsor
Riphah International University
Enrollment
19
Locations
1
Primary Endpoint
One leg standing test for Functional Activity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2024
End Date
September 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

One leg standing test for Functional Activity

Time Frame: Baseline 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 Activity

Time Frame: Baseline and 12th Week

The number of bilateral squats completed in 60 s is recorded

Secondary Outcomes

  • 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 Sites (1)

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