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Clubfoot DeformityNCT07249684

Myofascial Release And Static Stretching Along With Nighttime Bracing

A study testing Myofascial release and Static Stretching in people with Clubfoot Deformity, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this randomized controlled trial is to learn if Myofascial Release and Static Stretching combined with Nighttime Bracing can prevent long-term relapse of Ponseti-treated idiopathic clubfoot in children with idiopathic clubfoot. Read more about this study

Who is it for?
Ages Up to 14 months
Conditions the study is for
Clubfoot Deformity
What is being tested?
Myofascial release and Static Stretching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
3 Nov 2025to 1 Jan 2026
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 Up to 14 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children diagnosed with idiopathic clubfoot who have undergone initial correction using Ponseti method.
  • The patient is currently in the maintenance (post casting) phase of treatment.
  • Age between 0-14 months
  • Both unilateral and bilateral
  • Children who continue use of bracing for first 3 months
  • Both girls and boys

Who cannot join

  • Secondary clubfoot patients
  • Cases with a history of non-compliance with Ponseti treatment protocol.
  • Children who have the first 3 months on bracing stage

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Benazir Bhutto Hospital

    Islamabad, Punjab Province

Other trials in Pakistan

About this study

Official title: Effect of Myofascial Release and Static Stretching Along With Nighttime Bracing in Long-Term Relapse Prevention of Ponseti Treated Clubfoot

The goal of this randomized controlled trial is to learn if Myofascial Release and Static Stretching combined with Nighttime Bracing can prevent long-term relapse of Ponseti-treated idiopathic clubfoot in children with idiopathic clubfoot. The main questions it aims to answer are:

Does the addition of Myofascial Release and Static Stretching to Nighttime Bracing reduce the rate of long-term relapse in Ponseti-treated clubfoot? Does this combined intervention improve long-term mobility and quality of life in children with idiopathic clubfoot?

Read more

Researcher will compare the group receiving Myofascial Release with night time bracing o the group receiving Static Stretching along with Nighttime to see the effect of both intervention reduces relapse rates and improves functional outcomes.

Participants will:

Receive Myofascial Release and Static Stretching therapy sessions Use Nighttime Bracing as prescribed Undergo follow-up assessments to evaluate relapse occurrence, mobility, and quality of life

Read the detailed description

Clubfoot, or congenital talipes equinovarus, is a common congenital deformity occurring in 1 to 2 per 1,000 live births globally, with higher prevalence in males and certain populations. Defined by midfoot cavus, forefoot adducts, and hindfoot varus and equinus, its causes are multifactorial, involving genetic and environmental factors. Early diagnosis and intervention are essential to prevent lifelong pain and disability. With over 200,000 cases reported annually, the condition often affects both feet but can also present unilaterally, with some populations showing incidence rates as high as 5 per 1,000 births.

The Ponseti method is highly effective for correcting clubfoot initially, though relapse occurs in 30-40% of cases, commonly manifesting as equinus, adductus, or dynamic supination. Factors such as non-compliance with foot abduction orthosis (FAO), incomplete correction, or undiagnosed neuromuscular conditions contribute to relapse. Ensuring parent education, routine follow-ups, and timely bracing adjustments is crucial to reduce these risks.

Treatment options for clubfoot include repeat casting, Achilles tendon lengthening, or tibialis anterior tendon transfer, often avoiding extensive surgery. The Ponseti method, involving weekly manipulations, casting, Achilles tenotomy, Kinesio taping and bracing, achieves up to 98% initial correction but has a 37% relapse rate. Similarly, the French functional method, using manipulations, strapping, and exercises, shows comparable success but also struggles with recurrence.

MFR improves soft tissue flexibility by addressing residual tightness in the foot and lower leg, restoring tissue length, reducing stiffness, and enhancing blood flow for better alignment and functional mobility. Physiotherapy sessions focus on Achilles tendon stretching, mobilization of the tibiotalar, subtalar, and midtarsal joints, and strengthening of the peroneal muscles to promote eversion and stabilization. Proprioceptive exercises, balance training, and functional activities such as weight-bearing and gait training further support motor development. Nighttime bracing maintains the foot in a corrected position, ensuring that soft tissues and joints stay aligned during periods of inactivity.

This integrated approach significantly reduces the risk of relapse, enhances the effectiveness of Ponseti treatment, and improves the child's mobility and quality of life. MFR is a manual therapy technique targeting fascial restrictions to improve mobility, flexibility, and circulation. Fascia, a dense connective tissue surrounding muscles, bones, and organs, can contribute to stiffness and decreased range of motion (ROM) when restricted, increasing the risk of relapse in post-clubfoot treatment Static stretching is commonly used to enhance muscle-tendon flexibility and ROM by modifying passive muscle properties and stretching tolerance. While short-term stretching has limited effects on muscle-tendon unit stiffness (MTS), long-term stretching can significantly reduce stiffness, especially in healthy young individuals. In clubfoot management, static stretching of the gastrocnemius-soleus complex and plantar fascia helps prevent recurrence by maintaining tissue elongation, particularly when combined with nighttime bracing.

The aim of this randomized controlled trial to check the Effect of Myofascial Release and Static Stretching along with Nighttime Bracing in Long-Term Relapse Prevention of Ponseti Treated Clubfoot to optimize long-term mobility, enhance the quality of life for children with idiopathic clubfoot, and reduce the healthcare burden associated with relapse and disability.

Being tested
Myofascial release, Static Stretching
Keywords
Myofascial release, Static stretching, Clubfoot deformity, Ponseti Technique
Medical subject headings
Clubfoot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Myofascial releaseOther

    The intervention protocol for the experimental group (group A) includes Direct myofascial release on calf muscle (gastrocnemius and soleus) and tibialis posterior muscle for 2 mints.

    Total 4 sessions per week for 4 weeks with a total of 16 sessions.

    Conventional therapy: conventional therapy includes gentle mobilization of subtalar and talocrural joint grade2 (5 reps in 1 set) and night time brace.

    Total 4 sessions per week for 4 weeks with a total of 16 sessions.

  • Static StretchingOther

    intervention protocol for 2nd Experimental Group (Group B) includes static stretching of calf muscle (gastrocnemius and soleus and tibialis posterior (5 reps with 10 sec hold).

    Total 4 sessions per week for 4 weeks with a total of 16 sessions. conventional therapy: conventional therapy conventional therapy includes gentle mobilization of subtalar and talocrural joint grade 2 (5 reps in 1 set) and night time brace.

    Total 4 sessions per week for 4 weeks with a total of 16 sessions.

Study groups in NCT07249684
Study groupRoleWhat they receive
Myofascial releaseExperimentalThe intervention protocol for the experimental group (group A) includes Direct myofascial release on calf muscle (gastrocnemius and soleus) and tibialis posterior muscle for 2 mints. Total 4 sessions per week for 4 weeks with a total of 16 sessions. Conventional therapy: conventional therapy includes gentle mobilization of subtalar and talocrural joint grade2 (5 reps in 1 set) and night time brace. Total 4 sessions per week for 4 weeks with a total of 16 sessions.
Receives: Other: Myofascial release
static stretchingExperimentalintervention protocol for 2nd Experimental Group (Group B) includes static stretching of calf muscle (gastrocnemius and soleus and tibialis posterior (5 reps with 10 sec hold). Total 4 sessions per week for 4 weeks with a total of 16 sessions. conventional therapy: conventional therapy conventional therapy includes gentle mobilization of subtalar and talocrural joint grade 2 (5 reps in 1 set) and night time brace. Total 4 sessions per week for 4 weeks with a total of 16 sessions.
Receives: Other: Static Stretching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Goniometer

    To measure ankle range of motion (ROM) with a goniometer, position the patient sitting or lying supine with the knee flexed to 90 degrees. Place the goniometer's axis on the lateral malleolus, aligning the stationary arm with the lateral midline of the fibula and the moving arm parallel to the lateral midline of the fifth metatarsal. For dorsiflexion, pull patient's toes up toward the shin, and record the angle; for plantarflexion, have them point their toes downward, then record the angle.

    Measured: 3 weeks

  2. Pirani Scoring

    The Pirani score is a standardized clinical tool used to assess the severity of clubfoot deformity, primarily in pediatric patients undergoing Ponseti treatment. It evaluates six specific features across two categories: the midfoot and hindfoot. The midfoot score assesses the medial crease, curvature of the lateral border, and the position of the talus head, with each feature rated from 0 (normal) to 1 (severe), allowing for a maximum of 3 points. The hindfoot score evaluates the posterior crease, rigidity of equines (ankle dorsiflexion limitation), and the "empty heel" sign, with similar scoring criteria. The scores from both categories are combined for a total score ranging from 0 (fully corrected foot) to 6 (most severe deformity).

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start3 Nov 2025
  3. Primary completion1 Jan 2026
  4. Study completion1 Jan 2026

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07249684
Sponsor's protocol ID
Maryam Rehman MS-PT/02178
Status last verified
Apr 2026
First submitted
18 Nov 2025
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Myofascial release and Static Stretching in people with Clubfoot Deformity, 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 6 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 3 Apr 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?

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?

Goniometer (time frame: 3 weeks). 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?
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 3 Apr 2026.

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