- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06037746
Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus
September 14, 2023 updated by: Istanbul Gelisim University
Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus: A Single Blind, Randomized Controlled Pilot Study
The plantar fascia is a thick, multi-layered, non-elastic fibrous tissue band that extends along the plantar surface of the foot.The configuration of the plantar fascia is generally considered as a dense, longitudinally arranged fiber band divided into medial, central, and lateral components.
The most significant functional role of the plantar fascia is to maintain the arch structure of the foot, providing a stable support base while standing and absorbing dynamic reaction forces during walking.Pes planus is a rather general term with many definitions.
Staheli described pes planus as a "foot with a broad base of support," commonly known as flatfoot in layman's terms.
In a study involving 80 female participants aged 65 and older, 90% of foot deformities observed while standing were identified as pes planus.
Generally, pes planus is a condition characterized by excessive pronation of the rear part of the foot and a lowering of the medial longitudinal arch.
During the push-off phase of walking, the pronation moment generated by the ground reaction force flattens the arch as the subtalar joint rotation combines.
The shift in position in the talus bone causes the navicular bone to drop.
The plantar calcaneonavicular ligament tightens, and the tibialis posterior muscle lengthens.
Abnormalities in the bones of the foot, dysfunction of the tibialis posterior muscle, Achilles tendon shortening, or muscle weakness can contribute to pes planus.
Individuals with pes planus may experience foot and leg pain with exercise, physical activity, and prolonged walking, which can limit their level of physical activity.
Research has examined the relationship between pes planus and various physical parameters, and it has been found that one of these parameters, balance, is negatively affected by the presence of pes planus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participant information, including age, gender, height, body weight, and body mass index, was recorded using a general form.
Dynamic and static balance was assessed before and after the interventions in the study groups.
Three specialist physiotherapists conducted measurements and evaluations (navicular drop, static and dynamic balance).
The assessing physiotherapist remained consistent throughout, and they were unaware of the participant groups.
An expert in manual therapy administered the MRTs.
Statistical analysis was performed by a separate researcher uninvolved in the practical aspects of the study.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- 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 Locations
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Istanbul, Turkey
- İstanbul Gelişim University
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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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- volunteering for study participation,
- being between the ages of 18-25
- presence of pes planus.
Exclusion Criteria:
- Presence of orthopedic conditions other than pes planus,
- having a history of lower extremity surgery
- presence of neurological or rheumatological disorders,
- having a problem with vision or hearing
- participating in regular physical activity (>150 min/week)
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Graston Group
Miyofascial release was performed by graston tool on the entire plantar fascia.
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For the application, the individual was asked to lie face down, flex the knee to 90 degrees and release the ankle.
The therapist took a position next to the individual on the side to be treated.
Application was applied to the entire plantar fascia for 10 minutes in the longitudinal, vertical and oblique directions.
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Experimental: Percussive Massage Group
Miyofascial release was performed by theragun tool on the entire plantar fascia.
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For the application, the individual was asked to lie face down, flex the knee to 90 degrees and release the ankle.
The therapist took a position next to the individual on the side to be treated.
Application was applied to the entire plantar fascia for 5 minutes in all directions without being bound to a single direction.
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No Intervention: Control Group
No application has been made.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static Balance Test
Time Frame: Baseline and after immediately after intervention
|
The static balance level of individuals was measured with the Flamingo Balance Test, a valid and reliable instrument.
It was recorded how many times the individual fell or broke the test while trying to balance on one leg for 1 minute on a 15 cm long, 4 cm wide wooden plate.
During this period, each time the test was stopped, the timer was also stopped, and the timer was restarted after the individual repositioned.
The test was repeated 3 times, and the average value was recorded.
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Baseline and after immediately after intervention
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Dynamic Balance Test
Time Frame: Baseline and after immediately after intervention
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The dynamic balance level of individuals was measured with the "Y" Balance Test, a valid and reliable instrument, and their dominant extremities were evaluated.
While trying to balance on one foot at the midpoint of the assembly, the individual was asked to reach forward with the other foot in the anterior, posteromedial, and posterolateral directions and touch the tip of the toe.
The test was repeated 3 times in each direction, and the average value was recorded.
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Baseline and after immediately after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 25, 2022
Primary Completion (Actual)
December 25, 2022
Study Completion (Actual)
March 25, 2023
Study Registration Dates
First Submitted
September 7, 2023
First Submitted That Met QC Criteria
September 7, 2023
First Posted (Actual)
September 14, 2023
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 14, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PP001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It is not yet known if there will be a plan to make IPD available.
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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