- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06707844
TF and MFR on Calf Muscles in Patients With Pes Planus
Comparison of Tissue Flossing and Myofascial Release on Calf Muscles in Patients With Pes Planus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pes planus, or flat feet, is characterized by a reduced or absent arch, causing the entire sole to contact the ground. It is categorized into flexible and rigid types, with flexible pes planus being more common. In this form, the arch is visible in non-weight-bearing positions but flattens during standing or walking, while rigid pes planus remains flat irrespective of weight-bearing. The condition often results in foot instability, excessive eversion, and midfoot abduction, leading to pain, fatigue, and reduced shock absorption during activities.
Flexible flatfoot is prevalent in children but can persist into adulthood, affecting 2% to 23% of adults in the U.S. and 13.6% in India. It disrupts gait mechanics, shifting weight medially, impairing balance, and increasing injury risk. Management ranges from conservative treatments like physical therapy to surgical interventions in severe cases.
Emerging therapies include tissue flossing and myofascial release (MFR). Tissue flossing uses compression bands to improve blood flow, reduce pain, and enhance range of motion (ROM). In contrast, MFR applies sustained pressure to relieve fascial tension, promoting flexibility and reducing discomfort. Both techniques show promise for addressing the biomechanical and functional impairments associated with pes planus.
Literature review: According to literature, Galis et al. (2022) performed a study that aimed to examine the effects of applying tissue flossing band at different pressure levels on ankle ROM, strength and power performance in university students. The results showed an increase in dorsiflexion ROM and power. Furthermore, the author concluded that this can aid injury prevention, performance enhancement, and functional ability.
In another study, Driller et al. (2016) conducted a study on the effects of tissue flossing on ankle ROM and jump performance in recreational athletes. The study concluded that applying floss bands to the ankle effectively increased both dorsiflexion and plantarflexion ROM and enhances single-leg jump performance in recreational athletes.
Similarly, Choi et al. (2022) conducted a study aimed at investigating the impact of myofascial release of the peroneus longus muscle on the activity of the abductor hallucis muscle and the medial longitudinal arch in individuals with flexible pes planus. The results showed an increase in abductor hallucis muscle activity and elevation of the medial longitudinal arch.
A study conducted by Chang et al. (2021) examined the effect of a single session of tissue flossing on the knee joint in female college students. The results showed a significant improvement with a medium-to-large effect in the Y-Balance test assessment immediately postintervention. He concluded that tissue flossing can indeed enhance dynamic balance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Rawalpindi, Punjab Province, Pakistan, 46000
- Margalla Rehabilitation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-25 years.
- Having normal BMI ranging from 18.5 to 24.9 kg/m²
- Having flexible flat feet, defined as a navicular drop test value of ≥10 mm
- Must have pain in the calf muscles or ankle joint, with a NPRS score of ≥3
- Must have limited ankle dorsiflexion ROM, defined as ≤10° of dorsiflexion
Exclusion Criteria:
- Patients with rigid flatfoot
- History of ankle or calf muscle injury or surgery within the last 6 months
- Individuals with latex allergy
- Individuals having any lumbo-pelvic, hip, knee and ankle pathologies such as fractures, dislocations, degenerative diseases etc.
- Any neurological disease
- Pregnant females
- Individuals with BMI greater than or equal to 25.0 kg/m²
- Ongoing use of medications such as muscle relaxants or anti-inflammatory drugs
- Involved in athletic training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tissue flossing
Conventional Treatment |
Conventional treatment will include:
Tissue flossing involves wrapping a latex band around the calf muscles with 50-75% elongation, followed by active ankle movements (dorsiflexion, plantarflexion, circles, heel raises). Protocol: 4 sets of 8 repetitions, 10-second rest between sets Performed twice weekly for 3 weeks. |
|
Active Comparator: Myofascial release
Conventional Treatment |
Conventional treatment will include:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 3 weeks
|
This tool will be used to assess pain intensity, at baseline, 2nd week and 3rd week post treatment
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digital Goniometer
Time Frame: 3 weeks
|
It will be used for the measurement of ankle range of motion.
Changes from baseline, 2nd week and 3rd week will be taken.
|
3 weeks
|
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Brody's Navicular Drop Test
Time Frame: 3 weeks
|
It will be used for the measurement of navicular drop.
It is the one of the static foot assessment tools and is intended to represent the displacement of the navicular tuberosity from a neutral position.
Measurements taken at baseline, 2nd week and 3rd week
|
3 weeks
|
|
Single-Leg Stance Test
Time Frame: 3 weeks
|
It will be used to assess each patient's static balance with their eyes open and arms on hips.
Good static balance is indicated by participant's ability to maintain position for atleast 30 seconds.
Test will be repeated 3 times and average will be taken.
measurements will be taken at baseline, 2nd week and 3rd week.
|
3 weeks
|
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Y-Balance test
Time Frame: 3 weeks
|
It will be used for dynamic balance assessment.
Patient is asked to stand on one leg while reaching out in 3 different directions (anterior, posteromedial and posterolateral) with the other lower extremity.
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3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aneela Zia, MsOMPT, Riphah International University
Publications and helpful links
General Publications
- 1. R A, Malar A, J H, G S. The cause and frequency of PES Planus (Flat Foot) problems among young adults. Asian Journal of Medical Sciences. 2021;12(7):107-11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Talipes
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Flatfoot
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Massage
- Myofascial Release Therapy
Other Study ID Numbers
- REC/MS-PT/02019 Arfa Zafar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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