Pes PlanusPesPlanusNCT05788406
Effects of Dynamic Balance Exercise on Flexible Pes Planus
A study testing Short foot exercises, Dynamic balance exercises and insole in people with Pes Planus, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effects of intrinsic strengthening and dynamic balance exercises in patients with flexible pes planus. Forty-five participants aged 18 to 35 years were enrolled in the study, and the first group underwent intrinsic foot muscle strengthening training with short foot… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Short foot exercises, Dynamic balance exercises and insole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2023to 15 Jun 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients were included in the study if they were 152° above the MLA, participants with flexible pes planus at the 1st, 2nd, and 3rd level according to Jack's test, between 18 and 35 years of age, and had not received previous treatment for pes planus.
Who cannot join
- Individuals who had previously used orthotics, who had an orthopedic injury to the ankle, and who did not wish to participate in the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Dynamic Balance Exercises Affect Flexible Pes Planus?
The purpose of this study is to investigate the effects of intrinsic strengthening and dynamic balance exercises in patients with flexible pes planus. Forty-five participants aged 18 to 35 years were enrolled in the study, and the first group underwent intrinsic foot muscle strengthening training with short foot exercises (SFE) and used insoles. The second group trained using the dynamic balance board, which promotes dynamic balance and used insoles. The third group used only insoles. The total duration of treatment was 8 weeks/3 days. The degree of foot deformity was assessed with the, medial longitudinal arch (MLA) angle, measurements of subtalar angle and navicular drop test. Foot position assessed using Foot Posture Index (FPI) Static balance was assessed with the Flamingo Balance Test and dynamic balance with the " BOBO Health Platform with Gaming®" device.
Read the detailed description
Pes planus (flatfoot) is generally defined as valgus of the hindfoot, disappearance of the medial longitudinal arch (MLA) in the midfoot, and supination of the forefoot relative to the hindfoot when the foot is loaded. MLA height is the most important measurement for determining the degree of pes planus. The decrease in MLA disrupts this balance and causes the muscles and bones that are supposed to balance the effect of external forces to be subjected to greater stress. As a result, the balance is affected. Conservative treatment options that can be used as the first step in treating pes planus include activity modifications, exercises, manipulations, serial cast applications, weight loss, shoes changes, shoes modifications, use of foot orthotics. Several methods are used to strengthen foot intrinsic muscles, including toe towel curls, picking up objects, shin curls, unilateral balance activities, and the short foot exercise. The common exercises are strengthening exercises defined for intrinsic muscles, "short foot exercises" (SF). It is known that arch support insoles improve foot malalignment, correct dynamic posture, effectively support leg alignment and pain relief, and normalize gait. The use of silicone insoles is a product whose range of application has increased in recent years. The extremely soft and flexible material ensures that the shape of the foot is adopted. The researchers believed that the presence of a pes planus foot deformity, common in young people, negatively affects the balance of the individual, revealing small disturbances and different balance strategies. In this situation, the training of intrinsic muscles is of great importance. The investigators aim in this study is to investigate the effects of intrinsic muscle strengthening and dynamic balance exercises performed with silicone soles in individuals with flexible pes planus.
- Conditions
- Pes Planus
- Being tested
- Short foot exercises, Dynamic balance exercises and insole
- Keywords
- flexible pes planus, insole, balance
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short foot exercises, Dynamic balance exercises and insoleOther
Short foot exercises is used to improve muscle strenght, Dynamic balance exercises is used to improve balance and insole is used to improve MLA
| Study group | Role | What they receive |
|---|---|---|
| Short Foot Exercises Group | Experimental | İnsole+Short Foot Exercises group Receives: Other: Short foot exercises, Dynamic balance exercises and insole |
| Balance Exercises Group | Experimental | İnsole+Balance exercises group Receives: Other: Short foot exercises, Dynamic balance exercises and insole |
| Control Group | Experimental | İnsole group Receives: Other: Short foot exercises, Dynamic balance exercises and insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance performance
Dynamic balance was assessed using the BOBO Gaming Health Platform. With this system, which acts as a computerized strength platform, there are assessment and treatment phases. The individual was performed with the foot being tested on 2 sides of the platform. In all these evaluations, parameters related to body balance were analyzed. It gives performance scores in terms of percent.
Measured: 0-8 week
Secondary outcomes (4)
Foot Posture Index Score
Foot posture was analyzed using the Foot Posture Index. Palpation of the head of the talus in the hindfoot, inclination below and above the lateral malleolus, pronation/supination of the calcaneus, ballooning at the talonavicular joint in the forefoot, MLA structure, and abduction/adduction of the forefoot relative to the hindfoot were evaluated. Each of these criteria was assigned scores ranging from -2 to +2. The total score obtained was recorded and it indicated that the foot was in neutral position at 0, in pronation at positive values and in supination at negative values.
Measured: 0-8 week
Subtalar angle
Measurement of the subtalar angle between the Achilles tendon and the midpoint of the calcaneus was measured while the patient stood on a high platform. The pivot point was assumed to be 1 cm below the medial malleolus, and this area was marked. An angle greater than 5 degrees in the pronation or supination direction was considered abnormal.
Measured: 0-8 week
Static Balance Assessment
The patient flexed the foot behind the knee and held it with the hand in the same direction. When the patient was ready, he released the hand of the physiotherapist and at the same time the stopwatch was started. Each time the patient lost balance (touching the floor, releasing the foot), the stopwatch was stopped and restarted when the patient was ready 60 seconds. The total number of balance losses during this period was reported with number
Measured: 0-8 week
Angle of Medial longitudinal Arch
While measuring the MLA angle, a line was drawn from the center of the medial malleolus to the center of the navicular. The other line was drawn from the tuberosity of the navicular to the center of the first metatarsal head. The angle between these two lines was measured with a goniometer.
Measured: 0-8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start14 Mar 2023
- Primary completion1 May 2023
- Study completion15 Jun 2023
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.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylül Pınar KISA, Biruni University
- Investigators
- EylÜL pINAR Kısa, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788406
- Sponsor's protocol ID
- BirUni
- Acronym
- PesPlanus
- Status last verified
- Jun 2023
- First submitted
- 14 Mar 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dynamic Balance Exercises Affect Flexible Pes Planus?
- ClinicalTrials.gov ID
- NCT05788406
- Acronym / sponsor ID
- PesPlanus / BirUni
- Conditions
- Pes Planus
- Keywords
- flexible pes planus, insole, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 28 Mar 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 purpose of this study is to investigate the effects of intrinsic strengthening and dynamic balance exercises in patients with flexible pes planus. Forty-five participants aged 18 to 35 years were enrolled in the study, and the first group underwent intrinsic foot muscle strengthening training with short foot exercises (SFE) and used insoles. The second group trained using the dynamic balance board, which promotes dynamic balance and used insoles. The third group used only insoles. The total duration of treatment was 8 weeks/3 days. The degree of foot deformity was assessed with the, medial longitudinal arch (MLA) angle, measurements of subtalar angle and navicular drop test. Foot position assessed using Foot Posture Index (FPI) Static balance was assessed with the Flamingo Balance Test and dynamic balance with the " BOBO Health Platform with Gaming®" device.
Detailed description
Pes planus (flatfoot) is generally defined as valgus of the hindfoot, disappearance of the medial longitudinal arch (MLA) in the midfoot, and supination of the forefoot relative to the hindfoot when the foot is loaded. MLA height is the most important measurement for determining the degree of pes planus. The decrease in MLA disrupts this balance and causes the muscles and bones that are supposed to balance the effect of external forces to be subjected to greater stress. As a result, the balance is affected. Conservative treatment options that can be used as the first step in treating pes planus include activity modifications, exercises, manipulations, serial cast applications, weight loss, shoes changes, shoes modifications, use of foot orthotics. Several methods are used to strengthen foot intrinsic muscles, including toe towel curls, picking up objects, shin curls, unilateral balance activities, and the short foot exercise. The common exercises are strengthening exercises defined for intrinsic muscles, "short foot exercises" (SF). It is known that arch support insoles improve foot malalignment, correct dynamic posture, effectively support leg alignment and pain relief, and normalize gait. The use of silicone insoles is a product whose range of application has increased in recent years. The extremely soft and flexible material ensures that the shape of the foot is adopted. The researchers believed that the presence of a pes planus foot deformity, common in young people, negatively affects the balance of the individual, revealing small disturbances and different balance strategies. In this situation, the training of intrinsic muscles is of great importance. The investigators aim in this study is to investigate the effects of intrinsic muscle strengthening and dynamic balance exercises performed with silicone soles in individuals with flexible pes planus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short Foot Exercises Group | Experimental | Other: Short foot exercises, Dynamic balance exercises and insoleİnsole+Short Foot Exercises group |
| Balance Exercises Group | Experimental | Other: Short foot exercises, Dynamic balance exercises and insoleİnsole+Balance exercises group |
| Control Group | Experimental | Other: Short foot exercises, Dynamic balance exercises and insoleİnsole group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients were included in the study if they were 152° above the MLA, participants with flexible pes planus at the 1st, 2nd, and 3rd level according to Jack's test, between 18 and 35 years of age, and had not received previous treatment for pes planus.
Key exclusion criteria (1 listed)
- Individuals who had previously used orthotics, who had an orthopedic injury to the ankle, and who did not wish to participate in the study were excluded from the study.
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 |
|---|---|---|
| Short foot exercises, Dynamic balance exercises and insoleShort foot exercises is used to improve muscle strenght, Dynamic balance exercises is used to improve balance and insole is used to improve MLA | Other | Balance Exercises Group, Control Group, Short Foot Exercises Group |
Primary outcome
Dynamic Balance performance
Time frame: 0-8 week
Dynamic balance was assessed using the BOBO Gaming Health Platform. With this system, which acts as a computerized strength platform, there are assessment and treatment phases. The individual was performed with the foot being tested on 2 sides of the platform. In all these evaluations, parameters related to body balance were analyzed. It gives performance scores in terms of percent.
4 secondary outcomes
Foot Posture Index Score
Time frame: 0-8 week
Subtalar angle
Time frame: 0-8 week
Static Balance Assessment
Time frame: 0-8 week
Angle of Medial longitudinal Arch
Time frame: 0-8 week
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 27 Jun 2023.
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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.
EylÜL pINAR Kısa principal investigator
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short foot exercises, Dynamic balance exercises and insole in people with Pes Planus, run by Biruni 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 1 inclusion and 1 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 27 Jun 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?
Dynamic Balance performance (time frame: 0-8 week). 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 27 Jun 2023.