Myofascial Release And Static Stretching Along With Nighttime Bracing

NCT07249684 | Not Yet Recruiting DMC

• 1 other identifier: Maryam Rehman MS-PT/02178
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Clubfoot Deformity

Keywords

Myofascial release; Static stretching; Clubfoot deformity; Ponseti Technique

Outcome Measures

Primary Outcomes (2)

• 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.

  3 weeks

• 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).

  3 weeks

Study Arms (2)

Myofascial release

EXPERIMENTAL

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

static stretching

EXPERIMENTAL

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

Interventions

Myofascial release 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.

Myofascial release

Static Stretching 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.

static stretching

Eligibility Criteria

• Age: Up to 14 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Benazir Bhutto Hospital

Islamabad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Clubfoot

Interventions

Myofascial Release Therapy; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hafsa Siddiqui, MSOMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafsa Siddiqui, MS-OMPT

CONTACT

+923098528585; hafsa.siddiqui@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: November 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)