Myofascial Release And Static Stretching Along With Nighttime Bracing

NCT ID: NCT07249684

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-01-01

Brief 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. 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

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.

Conditions

Clubfoot Deformity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Myofascial release

Intervention Type: OTHER

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 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.

Group Type: EXPERIMENTAL

Static Stretching

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 14 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hafsa Siddiqui, MSOMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Benazir Bhutto Hospital

Islamabad, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Hafsa Siddiqui, MS-OMPT

Role: CONTACT

hafsa.siddiqui@riphah.edu.pk

+923098528585

Facility Contacts

Hafsa Siddiqui, MSOMPT

Role: primary

hafsa.siddiqui@riphah.edu.pk

923098528585

Maryam Rehman, MSOMPT*

Role: backup

Other Identifiers

Maryam Rehman MS-PT/02178

Identifier Type: -

Identifier Source: org_study_id