Club FootNCT07428902
Effects Of French Method With/Without Brace In Clubfoot Treatment
A study testing French method and Foot Abduction Brace and French Method only in people with Club Foot, run by Riphah International University at 1 site in Pakistan.
Trial summary
The current study will be a randomized control trial. Data will be collected from the Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD) and the Children Hospital and Institute of Child Health, Lahore. The study will include 18 patients, equally divided into two groups and randomly allocated. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Club Foot
- What is being tested?
- French method and Foot Abduction Brace and French Method only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Oct 2025to 23 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients under 12 months of age with clubfeet.
- All patients without previous clubfoot surgery were included.
- Children who have not received any prior corrective treatment or bracing for CTEV.
Who cannot join
- Patients with prior clubfoot surgery were excluded.
- Non-idiopathic cases (patients with underlying conditions) typically did not respond well to the nonoperative interventions and were less likely to be included for purely nonoperative treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Society for the Rehabilitation of the Disabled
Lahore, Punjab Province, 54000
Muhammad Asif Javed, MSPT, 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects Of French Method With And Without Foot Abduction Brace In Children With Congenital Talipes Equinovarus
The current study will be a randomized control trial. Data will be collected from the Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD) and the Children Hospital and Institute of Child Health, Lahore. The study will include 18 patients, equally divided into two groups and randomly allocated. Inclusion criteria will be children aged 0 to 12 months diagnosed with CTEV of either gender. Patients with neurological conditions, other orthopedic issues, previous surgical history related to the foot, severe systemic disorders, or neuromuscular disorders will be excluded from the study. The experimental group will receive the French method along with a foot abduction brace, while the control group will receive only the French method without the brace. Outcomes to be analyzed will include foot position, severity of deformity, and functional mobility. Data collection will occur before and after the intervention, utilizing clinical assessments for foot position, the Pirani score for severity of deformity, and standardized mobility assessments. Data will be analyzed using SPSS version 23.00.
Read the detailed description
Clubfoot, or talipes equinovarus, is a structural deformity of the foot and ankle characterized by hind foot equinus (plantar flexion), Varus of the heel (internal rotation), supination, and forefoot adduction (plantar cavus). The severity can range from mild to extremely rigid, manipulation-resistant cases. The incidence of clubfoot varies geographically, with a prevalence ranging from 0.5 to 2.0 cases per 1,000 live births across different regions. Early and effective intervention is crucial to prevent long-term disability, gait abnormalities, and functional limitations The French method, a conservative approach is widely used in treating CTEV. This approach involved daily manipulation of the newborn's foot, muscle stimulation (especially of the peroneal muscles), and temporary immobilization with adhesive strapping. However, the need for prolonged foot abduction bracing as a complement to the French method remains debatable. This study aims to compare the effects of the French method with and without the use of a foot abduction brace in managing CTEV in children.
The current study will be a randomized control trial. Data will be collected from the Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD) and the Children Hospital and Institute of Child Health, Lahore. The study will include 18 patients, equally divided into two groups and randomly allocated. Inclusion criteria will be children aged 0 to 12 months diagnosed with CTEV of either gender. Patients with neurological conditions, other orthopedic issues, previous surgical history related to the foot, severe systemic disorders, or neuromuscular disorders will be excluded from the study. The experimental group will receive the French method along with a foot abduction brace, while the control group will receive only the French method without the brace. Outcomes to be analyzed will include foot position, severity of deformity, and functional mobility. Data collection will occur before and after the intervention, utilizing clinical assessments for foot position, the Pirani score for severity of deformity, and standardized mobility assessments. Data will be analyzed using SPSS version 23.00.
- Conditions
- Club Foot
- Being tested
- French method and Foot Abduction Brace, French Method only
- Keywords
- Clubfoot, French Method, Foot Abduction Brace
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
French method and Foot Abduction BraceOther
The experimental group will follow the French method with the addition of a foot abduction brace, which is worn after each session.
French Method onlyOther
The control group will receive the French method only, without a foot abduction brace. The intervention includes manual manipulation to correct deformities through soft tissue stretching and joint mobilization; stretching exercises for dorsiflexion, abduction, and eversion to maintain range of motion; and taping for stabilization after manipulation. Gentle calf and foot massage will reduce stiffness and promote relaxation. Daily sessions of 30-45 minutes will be conducted for 2-3 months. Parents will be trained to perform gentle stretches, monitor foot position, recognize signs of poor circulation or discomfort, and apply taping correctly. They will be advised to continue exercises at home between follow-up visits to maintain correction and ensure continued improvement.
| Study group | Role | What they receive |
|---|---|---|
| Group A:Intervention Group(French Method with Foot Abduction Brace) | Active comparator | The experimental group will receive the French method with a foot abduction brace worn to maintain correction. Receives: Other: French method and Foot Abduction Brace |
| Group B:Control Group(French Method only) | Active comparator | The control group will receive the French method only, without a foot abduction brace. Receives: Other: French Method only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pirani Scoring System for Clubfoot Assessment & Demeglio Classification System for Clubfoot Severity
Pirani Scoring System for Clubfoot Assessment:The Pirani Score is a widely used clinical tool to assess the severity of congenital talipes equinovarus (clubfoot). This scoring system helps in evaluating the extent of deformity and in monitoring the progress of treatment, especially when using methods like the Ponseti method or the French method. It focuses on six key aspects of the foot, Each of these six components is scored from 0 to 1.The total score ranges from 0 (normal foot) to 6 (severely affected foot). The higher the score, the more severe the clubfoot.
Measured: Baseline,12 weeks
Secondary outcomes (1)
Demeglio Classification System for Clubfoot Severity
DimS is based on correction after applying a gentle reduction force.6 Four parameters are evaluated: varus (VA), equinus (E-Dim), derotation of calcaneo-forefoot block (DER) and midfoot adduction (ADD). Each is scored on a five-point scale (0 to 4 points) resulting in a maximum score of 16 points for the most severe deformity. An additional four points result from the absence/presence (0/1 point) of four pejorative items: posterior crease (PC-Dim), medial crease (MC-Dim), cavus and abnormal musculature (MUSC). Once a total score (0 to 20 points) is calculated, feet are divided in four grades: grade I (0-5 points), II (6-10), III (11-15) and IV (16-20 points).
Measured: Baseline,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start28 Oct 2025
- Primary completion20 Feb 2026 (estimated)
- Study completion23 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial will be conducted at the Pakistan Society for the Rehabilitation of the Disabled (PSRD) and the Children's Hospital and Institute of Child Health, Lahore. Eighteen children aged 0-12 months diagnosed with congenital talipes equinovarus (CTEV) will be randomly divided into two equal groups. Children with neurological, orthopedic, or neuromuscular disorders, prior foot surgery, or severe systemic illness will be excluded. The experimental group will receive the French method with a foot abduction brace, while the control group will receive only the French method. Foot position, deformity severity, and functional mobility will be assessed pre- and post-intervention using the Pirani score and standardized clinical measures. Data will be analyzed using SPSS version 23.0.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shama Khizar, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428902
- Sponsor's protocol ID
- REC/RCR&AHS/SHAMAKHIZAR
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bettuzzi C, Abati CN, Salvatori G, Zanardi A, Lampasi M. Interobserver reliability of Dimeglio and Pirani score and their subcomponents in the evaluation of idiopathic clubfoot in a clinical setting: a need for improved scoring systems. J Child Orthop. 2019 Oct 1;13(5):478-485. doi: 10.1302/1863-2548.13.190010.
PubMed 31695815
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of French Method With And Without Foot Abduction Brace In Children With Congenital Talipes Equinovarus
- ClinicalTrials.gov ID
- NCT07428902
- Acronym / sponsor ID
- REC/RCR&AHS/SHAMAKHIZAR
- Conditions
- Club Foot
- Keywords
- Clubfoot, French Method, Foot Abduction Brace
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 23 Feb 2026 (estimated)
- First posted
- 24 Feb 2026 (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.
The current study will be a randomized control trial. Data will be collected from the Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD) and the Children Hospital and Institute of Child Health, Lahore. The study will include 18 patients, equally divided into two groups and randomly allocated. Inclusion criteria will be children aged 0 to 12 months diagnosed with CTEV of either gender. Patients with neurological conditions, other orthopedic issues, previous surgical history related to the foot, severe systemic disorders, or neuromuscular disorders will be excluded from the study. The experimental group will receive the French method along with a foot abduction brace, while the control group will receive only the French method without the brace. Outcomes to be analyzed will include foot position, severity of deformity, and functional mobility. Data collection will occur before and after the intervention, utilizing clinical assessments for foot position, the Pirani score for severity of deformity, and standardized mobility assessments. Data will be analyzed using SPSS version 23.00.
Detailed description
Clubfoot, or talipes equinovarus, is a structural deformity of the foot and ankle characterized by hind foot equinus (plantar flexion), Varus of the heel (internal rotation), supination, and forefoot adduction (plantar cavus). The severity can range from mild to extremely rigid, manipulation-resistant cases. The incidence of clubfoot varies geographically, with a prevalence ranging from 0.5 to 2.0 cases per 1,000 live births across different regions. Early and effective intervention is crucial to prevent long-term disability, gait abnormalities, and functional limitations The French method, a conservative approach is widely used in treating CTEV. This approach involved daily manipulation of the newborn's foot, muscle stimulation (especially of the peroneal muscles), and temporary immobilization with adhesive strapping. However, the need for prolonged foot abduction bracing as a complement to the French method remains debatable. This study aims to compare the effects of the French method with and without the use of a foot abduction brace in managing CTEV in children.
The current study will be a randomized control trial. Data will be collected from the Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD) and the Children Hospital and Institute of Child Health, Lahore. The study will include 18 patients, equally divided into two groups and randomly allocated. Inclusion criteria will be children aged 0 to 12 months diagnosed with CTEV of either gender. Patients with neurological conditions, other orthopedic issues, previous surgical history related to the foot, severe systemic disorders, or neuromuscular disorders will be excluded from the study. The experimental group will receive the French method along with a foot abduction brace, while the control group will receive only the French method without the brace. Outcomes to be analyzed will include foot position, severity of deformity, and functional mobility. Data collection will occur before and after the intervention, utilizing clinical assessments for foot position, the Pirani score for severity of deformity, and standardized mobility assessments. Data will be analyzed using SPSS version 23.00.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This randomized controlled trial will be conducted at the Pakistan Society for the Rehabilitation of the Disabled (PSRD) and the Children's Hospital and Institute of Child Health, Lahore. Eighteen children aged 0-12 months diagnosed with congenital talipes equinovarus (CTEV) will be randomly divided into two equal groups. Children with neurological, orthopedic, or neuromuscular disorders, prior foot surgery, or severe systemic illness will be excluded. The experimental group will receive the French method with a foot abduction brace, while the control group will receive only the French method. Foot position, deformity severity, and functional mobility will be assessed pre- and post-intervention using the Pirani score and standardized clinical measures. Data will be analyzed using SPSS version 23.0.
| Arm | Type | Receives |
|---|---|---|
| Group A:Intervention Group(French Method with Foot Abduction Brace) | Active comparator | Other: French method and Foot Abduction BraceThe experimental group will receive the French method with a foot abduction brace worn to maintain correction. |
| Group B:Control Group(French Method only) | Active comparator | Other: French Method onlyThe control group will receive the French method only, without a foot abduction brace. |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients under 12 months of age with clubfeet.
- All patients without previous clubfoot surgery were included.
- Children who have not received any prior corrective treatment or bracing for CTEV.
Key exclusion criteria (2 listed)
- Patients with prior clubfoot surgery were excluded.
- Non-idiopathic cases (patients with underlying conditions) typically did not respond well to the nonoperative interventions and were less likely to be included for purely nonoperative treatment.
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 |
|---|---|---|
| French method and Foot Abduction BraceThe experimental group will follow the French method with the addition of a foot abduction brace, which is worn after each session. | Other | Group A:Intervention Group(French Method with Foot Abduction Brace) |
| French Method onlyThe control group will receive the French method only, without a foot abduction brace. The intervention includes manual manipulation to correct deformities through soft tissue stretching and joint mobilization; stretching exercises for dorsiflexion, abduction, and eversion to maintain range of motion; and taping for stabilization after manipulation. Gentle calf and foot massage will reduce stiffness and promote relaxation. Daily sessions of 30-45 minutes will be conducted for 2-3 months. Parents will be trained to perform gentle stretches, monitor foot position, recognize signs of poor circulation or discomfort, and apply taping correctly. They will be advised to continue exercises at home between follow-up visits to maintain correction and ensure continued improvement. | Other | Group B:Control Group(French Method only) |
Primary outcome
Pirani Scoring System for Clubfoot Assessment & Demeglio Classification System for Clubfoot Severity
Time frame: Baseline,12 weeks
Pirani Scoring System for Clubfoot Assessment:The Pirani Score is a widely used clinical tool to assess the severity of congenital talipes equinovarus (clubfoot). This scoring system helps in evaluating the extent of deformity and in monitoring the progress of treatment, especially when using methods like the Ponseti method or the French method. It focuses on six key aspects of the foot, Each of these six components is scored from 0 to 1.The total score ranges from 0 (normal foot) to 6 (severely affected foot). The higher the score, the more severe the clubfoot.
1 secondary outcome
Demeglio Classification System for Clubfoot Severity
Time frame: Baseline,12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 31695815Bettuzzi C, Abati CN, Salvatori G, Zanardi A, Lampasi M. Interobserver reliability of Dimeglio and Pirani score and their subcomponents in the evaluation of idiopathic clubfoot in a clinical setting: a need for improved scoring systems. J Child Orthop. 2019 Oct 1;13(5):478-485. doi: 10.1302/1863-2548.13.190010.
- 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.
Shama Khizar, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing French method and Foot Abduction Brace and French Method only 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PhD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pirani Scoring System for Clubfoot Assessment & Demeglio Classification System for Clubfoot Severity (time frame: Baseline,12 weeks). 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 NCT07428902, which also lists 1 linked publication.
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 24 Feb 2026.