Club FootNCT06407739
Three Phase Physical Therapy in Children With Relapsed Club Foot After Ponseti Treatment
A study testing Three-Phase Physical Therapy Intervention in people with Club Foot, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Club Foot
- What is being tested?
- Three-Phase Physical Therapy Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2024to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children who were diagnosed with arthrogryposis multiplex congentia
- Children with spastic Equinovarus
- Children who had multiple surgical operation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
pakistan Society for the Rehabilitaion of Disables
Lahore, Punjab Province, 05308
About this study
Official title: 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.
- Conditions
- Club Foot
- Being tested
- Three-Phase Physical Therapy Intervention
- Keywords
- Club foot, Ponseti technique, Three-phase physical therapy
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Phase Physical Therapy InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Three-Phase Physical Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 12th Week
Sit to stand test for Functional Activity
The number of bilateral squats completed in 60 s is recorded
Measured: Baseline and 12th Week
Secondary outcomes (2)
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.
Measured: 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
Measured: Baseline and 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 May 2024
- Primary completion5 Aug 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Club FootStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Kausar, Principal investigator, Riphah International University, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407739
- Sponsor's protocol ID
- REC/RCR & AHS/23/0770
- Status last verified
- Mar 2025
- First submitted
- 6 May 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32379245Grin 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 34583148Masrouha 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Phase Physical Therapy on Functional Activity in Children With Relapsed Club Foot After Ponseti Treatment
- ClinicalTrials.gov ID
- NCT06407739
- Acronym / sponsor ID
- REC/RCR & AHS/23/0770
- Conditions
- Club Foot
- Keywords
- Club foot, Ponseti technique, Three-phase physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three-Phase Physical Therapy Intervention | Experimental | Other: Three-Phase Physical Therapy InterventionThis group will be given the three-phase physical therapy intervention and each phase prolong for period of one month |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Children who were diagnosed with arthrogryposis multiplex congentia
- Children with spastic Equinovarus
- Children who had multiple surgical operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-Phase Physical Therapy InterventionPhase 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 | Other | Three-Phase Physical Therapy Intervention |
Primary outcome
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
2 secondary outcomes
Pirani score for Clubfoot Severity
Time frame: Baseline and 12th Week
The oxford Ankle Foot questionnaire for children and parent for Functional Status
Time frame: Baseline and 12th Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- BackgroundBent MA. Congenital Talipes Equinovarus (Clubfoot). Orthopaedics for the Newborn and Young Child: A Practical Clinical Guide: Springer; 2023. p. 47-60.
- Background: PubMed 32379245Novotny 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.
- Background: PubMed 34583148Grin 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.
- Background: PubMed 34423014Masrouha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fareeha Kausar principal investigator
Riphah International University, Lahore, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-Phase Physical Therapy Intervention in people with Club Foot, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One leg standing test for Functional Activity (time frame: Baseline and 12th Week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06407739, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.