Pes PlanusNCT06238505
Acute Efficacy of Exercises Applied With Xbox and Biodex Devices in Pes Planus"
A study testing Virtual and biodex in people with Pes Planus, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
.Pes planus; It can be defined as the valgus of the hindfoot while loading the foot, the disappearance of the medial longitudinal arch in the midfoot, and the supination of the forefoot relative to the hindfoot. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Virtual and biodex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Feb 2024to 10 Jul 2024
- 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
- Having mild and moderate pes planus,
- Volunteering of individuals,
- Being between the age group of 18-25,
- Having experienced at least one inflammatory symptom (pain, swelling, etc.)
- Not having any systemic, locomotor and foot related diseases, sensory loss, diabetic and peripheral neuropathy.
Who cannot join
- Having had a serious lower extremity injury in the last 6 months,
- Getting a full score from the balance test,
- Having ligament rupture in the ankle.
Trial locations and contacts
1 site in 1 country.
Ali Rıza ÇELİK contact
About this study
.Pes planus; It can be defined as the valgus of the hindfoot while loading the foot, the disappearance of the medial longitudinal arch in the midfoot, and the supination of the forefoot relative to the hindfoot. It may also occur due to the fact that the medial longitudinal arch in the foot is lower than the required height according to the anatomical position. The parts of the foot that touch the ground are anatomically healthy in a person; They are the heads of the calcaneus tuberositas calcanei on the back of the foot and the 5 metatarsal bones on the front of the foot. In the standing position, 25% of our body weight is on the tuber calcanei, while 25% is on the 5 metatarsal bones. In individuals with pes planus, convergence of the sole of the midfoot to the ground may even result in the sole of the midfoot touching the ground at its advanced levels. It is one of the common foot deformities.
Read the detailed description
pes planus can cause symptoms and dysfunction that are symptomatic or severe enough to limit patients' quality of life. Degeneration of the posterior tibial tendon may occur due to trauma, neuroarthropathy, neuromuscular disease and inflammatory arthritis. Among these, the most common cause of pes planus is the degeneration of the posterior tibial tendon.
The highest arch of the foot, the medical longitudinal arch calcaneus, talus, navicular, cuneiform and 1-2-3. It is formed by metatarsals. It is effective in the distribution of the load on the feet. Plantar ligaments are important in protecting the dome of the foot.
They used many definitions known as pes planus, that is, flat feet in the literature. Weak foot, relaxed foot, pes valgus, congenital hypermobile flat foot, hypermobile flat foot, flaccid flat food, talipes calcaneovalgus, compensated talipes equinus can be given as examples.
- Conditions
- Pes Planus
- Being tested
- Virtual, biodex
- Keywords
- pes planus, exercise
- Medical subject headings
- Flatfoot, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VirtualOther
application will be made with virtual reality device
biodexOther
application will be made with biodex device
| Study group | Role | What they receive |
|---|---|---|
| Virtual | Experimental | Not described Receives: Other: Virtual |
| biodex | Experimental | Not described Receives: Other: biodex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex device
The Biodex balance device is a specialized device used for balance training and assessment. It is designed to evaluate and improve an individual's balance, stability and proprioception. The system includes a computerized platform that provides real-time feedback and exercises for balance training. It allows assessment in the anterior and medial and posterior direction.
Measured: 1 day
Y Balance Test
The Y Balance Test is a functional movement assessment test used to evaluate a person's dynamic balance, core strength and proprioception ability. The Y Balance Test involves reaching movements in three directions (anterior, posteromedial and posterolateral). The person stands in the center with one leg on a Y-shaped platform and reaches with the other leg in the indicated direction as far as possible while maintaining balance. .
Measured: 1 day
Foot Pressure Analysis
These platforms measure the force applied to the sole of the foot and load distribution through electronic sensor
Measured: 1 day
The Foot Posture Index
The Foot Posture Index is a six-criteria observational scoring system that provides a necessary measure of foot posture when the patient is standing. This system is a clinical scale for assessing the postural structure of the foot. The anatomical and biomechanical features of the foot are assessed and foot posture is classified as neutral, pronated or supinated. Its calculation consists of six different visual criteria or markers. These criteria include hindfoot position characterized by the subtalar joint, midfoot position, protrusion of the medial longitudinal arch, abduction and adduction of the forefoot, alignment of the toes, and whether the foot is supinated or pronated. Positive scores are given when pronation is observed, while negative scores are given when supination is observed
Measured: 1 day
Navicular drop
Navicular drop test is a test used in the evaluation of ankle and lower extremity biomechanics. This test is especially used to provide information about pronation and the placement of the navicular bone. The test includes the following steps: The person stands on a flat surface with bare feet or thin socks. The sole of the feet and ankle position are observed. The ankle and foot structure is observed while the person gives a full load (stands up fully) and walks or strides to compensate for the pressure. How much the navicular bone in the center of the sole of the foot drops under load or during movement is measured.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start6 Feb 2024 (estimated)
- Primary completion6 Feb 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes PlanusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238505
- Sponsor's protocol ID
- 2023-19/02
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Efficacy of Exercises Applied With Xbox and Biodex Devices in Pes Planus"
- ClinicalTrials.gov ID
- NCT06238505
- Acronym / sponsor ID
- 2023-19/02
- Conditions
- Pes Planus
- Keywords
- pes planus, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 6 Feb 2024 (estimated)
- Primary completion
- 6 Feb 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 2 Feb 2024 (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.
.Pes planus; It can be defined as the valgus of the hindfoot while loading the foot, the disappearance of the medial longitudinal arch in the midfoot, and the supination of the forefoot relative to the hindfoot. It may also occur due to the fact that the medial longitudinal arch in the foot is lower than the required height according to the anatomical position. The parts of the foot that touch the ground are anatomically healthy in a person; They are the heads of the calcaneus tuberositas calcanei on the back of the foot and the 5 metatarsal bones on the front of the foot. In the standing position, 25% of our body weight is on the tuber calcanei, while 25% is on the 5 metatarsal bones. In individuals with pes planus, convergence of the sole of the midfoot to the ground may even result in the sole of the midfoot touching the ground at its advanced levels. It is one of the common foot deformities.
Detailed description
pes planus can cause symptoms and dysfunction that are symptomatic or severe enough to limit patients' quality of life. Degeneration of the posterior tibial tendon may occur due to trauma, neuroarthropathy, neuromuscular disease and inflammatory arthritis. Among these, the most common cause of pes planus is the degeneration of the posterior tibial tendon.
The highest arch of the foot, the medical longitudinal arch calcaneus, talus, navicular, cuneiform and 1-2-3. It is formed by metatarsals. It is effective in the distribution of the load on the feet. Plantar ligaments are important in protecting the dome of the foot.
They used many definitions known as pes planus, that is, flat feet in the literature. Weak foot, relaxed foot, pes valgus, congenital hypermobile flat foot, hypermobile flat foot, flaccid flat food, talipes calcaneovalgus, compensated talipes equinus can be given as examples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual | Experimental | Other: Virtual |
| biodex | Experimental | Other: biodex |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having mild and moderate pes planus,
- Volunteering of individuals,
- Being between the age group of 18-25,
- Having experienced at least one inflammatory symptom (pain, swelling, etc.)
- Not having any systemic, locomotor and foot related diseases, sensory loss, diabetic and peripheral neuropathy.
Key exclusion criteria (3 listed)
- Having had a serious lower extremity injury in the last 6 months,
- Getting a full score from the balance test,
- Having ligament rupture in the ankle.
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 |
|---|---|---|
| Virtualapplication will be made with virtual reality device | Other | Virtual |
| biodexapplication will be made with biodex device | Other | biodex |
Primary outcome
Biodex device
Time frame: 1 day
The Biodex balance device is a specialized device used for balance training and assessment. It is designed to evaluate and improve an individual's balance, stability and proprioception. The system includes a computerized platform that provides real-time feedback and exercises for balance training. It allows assessment in the anterior and medial and posterior direction.
Y Balance Test
Time frame: 1 day
The Y Balance Test is a functional movement assessment test used to evaluate a person's dynamic balance, core strength and proprioception ability. The Y Balance Test involves reaching movements in three directions (anterior, posteromedial and posterolateral). The person stands in the center with one leg on a Y-shaped platform and reaches with the other leg in the indicated direction as far as possible while maintaining balance. .
Foot Pressure Analysis
Time frame: 1 day
These platforms measure the force applied to the sole of the foot and load distribution through electronic sensor
The Foot Posture Index
Time frame: 1 day
The Foot Posture Index is a six-criteria observational scoring system that provides a necessary measure of foot posture when the patient is standing. This system is a clinical scale for assessing the postural structure of the foot. The anatomical and biomechanical features of the foot are assessed and foot posture is classified as neutral, pronated or supinated. Its calculation consists of six different visual criteria or markers. These criteria include hindfoot position characterized by the subtalar joint, midfoot position, protrusion of the medial longitudinal arch, abduction and adduction of the forefoot, alignment of the toes, and whether the foot is supinated or pronated. Positive scores are given when pronation is observed, while negative scores are given when supination is observed
Navicular drop
Time frame: 1 day
Navicular drop test is a test used in the evaluation of ankle and lower extremity biomechanics. This test is especially used to provide information about pronation and the placement of the navicular bone. The test includes the following steps: The person stands on a flat surface with bare feet or thin socks. The sole of the feet and ankle position are observed. The ankle and foot structure is observed while the person gives a full load (stands up fully) and walks or strides to compensate for the pressure. How much the navicular bone in the center of the sole of the foot drops under load or during movement is measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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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.
Ali Rıza ÇELİK contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual and biodex in people with Pes Planus, run by Istanbul Medipol University Hospital 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hazal GENÇ, PhD (+905413204291, hazaloksuz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex device (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.