ClinicalTrials.gg
CompletedNCT06407739Updated Mar 12, 2025

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

An interventional study of Three-Phase Physical Therapy Intervention in Club Foot, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
3 Years to 10 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Clubfoot with a site in Pakistan — 4 open to participants now, 5 under way, none of them phase 3. Clubfoot · Pakistan.

Started
2024
the only one that year
No phase
8 of 10
3 open now
Registered
4th of 10
by date
Lead sponsor
4 of 10
Riphah International University

Among the 10 studies in Clubfoot with a site in Pakistan, this one is the only one that started in 2024, is one of 8 with no phase, and was the 4th registered.

Clubfoot

69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.

Browse Clubfoot studies →

Open to participants now

4 of the 10 studies in Clubfoot with a site in Pakistan are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Pakistan have not opened yet or have stopped. Only those recruiting at a site in Pakistan →

Who these studies take

Of the 10 Clubfoot studies recruiting now, none (0%) set no upper age limit and 10 (100%) stop at 75 or younger; 9 take children under 18; none take healthy volunteers.

This study: 3 Years to 10 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Club Foot

Browse trials for

Keywords

  • Club foot
  • Ponseti technique
  • Three-phase physical therapy
04

Who can participate

Ages eligible
3 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Children who were diagnosed with arthrogryposis multiplex congentia
  • Children with spastic Equinovarus
  • Children who had multiple surgical operation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • 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

Interventions

  • OtherThree-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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and 12th Week

  2. Sit to stand test for Functional Activity

    The number of bilateral squats completed in 60 s is recorded

    Time frame: Baseline and 12th Week

Secondary outcomes

  1. 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.

    Time frame: Baseline and 12th Week

  2. 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

    Time frame: Baseline and 12th Week

07

Study locations

1 site
  • pakistan Society for the Rehabilitaion of Disables
    Lahore, Punjab 05308, Pakistan
08

References and documents

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. PubMed 32379245 ↗
  • 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. PubMed 34583148 ↗
  • 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. PubMed 34423014 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2024 to primary completion in Aug 2024, 2 months.

Of 20 interventional studies with no phase under Clubfoot, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2024
First posted
May 9, 2024
StartActual
May 15, 2024
Primary completionActual
Aug 5, 2024
CompletionActual
Sep 15, 2024
Last update
Mar 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06407739
Responsible party
Sponsor
First posted
May 9, 2024
Start date
May 15, 2024
Primary completion
Aug 5, 2024
Completion
Sep 15, 2024
Last update
Mar 12, 2025

Study contacts

Fareeha Kausar
principal investigator · Riphah International University, Lahore, Pakistan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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