Flat FootNCT06037746
Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus
A study testing Graston and Percussive massage in people with Flat Foot, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Flat Foot
- What is being tested?
- Graston and Percussive massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2022to 25 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- volunteering for study participation,
- being between the ages of 18-25
- presence of pes planus.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Flat Foot
- Being tested
- Graston, Percussive massage
- Keywords
- Pes Planus, Myofascial Release, Postural Balance, Randomized Controlled Trial
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrastonOther
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.
Percussive massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Graston Group | Experimental | Miyofascial release was performed by graston tool on the entire plantar fascia. Receives: Other: Graston |
| Percussive Massage Group | Experimental | Miyofascial release was performed by theragun tool on the entire plantar fascia. Receives: Other: Percussive massage |
| Control Group | No intervention | No application has been made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance Test
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.
Measured: Baseline and after immediately after intervention
Dynamic Balance Test
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.
Measured: Baseline and after immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start25 Mar 2022
- Primary completion25 Dec 2022
- Study completion25 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Flat FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037746
- Sponsor's protocol ID
- PP001
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Kethudaoglu MO, Ozdemir AE, Kaya Saglam O, Caglar E, Meran Caglar M, Demir G, Duymaz T. Immediate effects of soft tissue mobilization and percussive massage on balance in young adults with pes planus: A single blind, randomized controlled pilot study. J Bodyw Mov Ther. 2024 Oct;40:397-402. doi: 10.1016/j.jbmt.2024.04.034. Epub 2024 Apr 19.
PubMed 39593615
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus: A Single Blind, Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06037746
- Acronym / sponsor ID
- PP001
- Conditions
- Flat Foot
- Keywords
- Pes Planus, Myofascial Release, Postural Balance, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Graston Group | Experimental | Other: GrastonMiyofascial release was performed by graston tool on the entire plantar fascia. |
| Percussive Massage Group | Experimental | Other: Percussive massageMiyofascial release was performed by theragun tool on the entire plantar fascia. |
| Control Group | No intervention | –No application has been made. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- volunteering for study participation,
- being between the ages of 18-25
- presence of pes planus.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrastonFor 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. | Other | Graston Group |
| Percussive massageFor 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. | Other | Percussive Massage Group |
Primary outcome
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.
Dynamic Balance Test
Time frame: Baseline and after immediately after intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 39593615Kethudaoglu MO, Ozdemir AE, Kaya Saglam O, Caglar E, Meran Caglar M, Demir G, Duymaz T. Immediate effects of soft tissue mobilization and percussive massage on balance in young adults with pes planus: A single blind, randomized controlled pilot study. J Bodyw Mov Ther. 2024 Oct;40:397-402. doi: 10.1016/j.jbmt.2024.04.034. Epub 2024 Apr 19.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graston and Percussive massage in people with Flat Foot, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance Test (time frame: Baseline and after immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06037746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.