Myofascial Release And Static Stretching Along With Nighttime Bracing

April 2, 2026 updated by: Riphah International University

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?

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab Province
      • Islamabad, Punjab Province, Pakistan
        • Benazir Bhutto Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Myofascial release

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.
Other: Myofascial release

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.
Experimental: static stretching

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.
Other: Static Stretching

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Goniometer
Time Frame: 3 weeks
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.
3 weeks
Pirani Scoring
Time Frame: 3 weeks
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).
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hafsa Siddiqui, MSOMPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Maryam Rehman MS-PT/02178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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