Foot DiseasesNCT07260747
Comparison of the Effects of Virtual Reality-Based Interventions on Foot Function, Foot Pressure, and Balance in Sedentary Individuals
A study testing VR Biodex Group and Video-Based VR Group in people with Foot Diseases, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the Effects of Virtual Reality-Based Interventions on Foot Function, Foot Pressure, and Balance in Sedentary Individuals Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Diseases
- What is being tested?
- VR Biodex Group and Video-Based VR Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Oct 2025to 7 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary Individual
- Individuals between the ages of 18-25
- Being a university student
Who cannot join
- Athletes
- Individuals with orthopedic or neurological problems.
- Surgery history
- Cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bahceşehir University Health Center
Istanbul, 34070
HAZAL genç, phd
About this study
Comparison of the Effects of Virtual Reality-Based Interventions on Foot Function, Foot Pressure, and Balance in Sedentary Individuals
- Conditions
- Foot Diseases
- Being tested
- VR Biodex Group, Video-Based VR Group, Control Group
- Keywords
- exercise, foot
- Medical subject headings
- Foot Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Biodex GroupOther
This group will participate in a virtual reality-supported rehabilitation program integrated with the Biodex Balance System device.
Video-Based VR GroupOther
: Participants in this group will perform balance and foot exercises accompanied by exercise videos containing visual guidance.
Control GroupOther
This group will follow a traditional home exercise program without any virtual reality intervention.
| Study group | Role | What they receive |
|---|---|---|
| VR Biodex Group | Experimental | This group will participate in a virtual reality-supported rehabilitation program integrated with the Biodex Balance System device. Participants will perform interactive balance and postural stability exercises through this system Receives: Other: VR Biodex Group |
| Video-Based VR Group | Active comparator | Participants in this group will perform balance and foot exercises accompanied by exercise videos containing visual guidance. This intervention aims to provide the virtual reality experience through video-based content. Receives: Other: Video-Based VR Group |
| Control Group | Active comparator | This group will follow a traditional home exercise program without any virtual reality intervention. This group will serve as a baseline for comparing the results of the other two groups Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Function Assessment
Foot pain, disability, and activity limitation will be assessed using the Foot Function Index (FFI), a validated 23-item questionnaire. The total FFI score ranges from 0 to 100, with higher scores indicating worse foot function (greater pain, disability, and activity limitation).
Measured: 6 weeks
Foot Pressure Assessment - Maximum Plantar Pressure
Plantar pressure during standing and walking will be assessed using a pedobarographic measurement system. Maximum plantar pressure will be recorded, with higher values indicating greater localized loading on the foot.
Measured: 6 weeks
Foot Pressure Assessment - Contact Area
The pedobarographic system will measure the total plantar contact area during standing and walking. Larger contact area values indicate greater surface area participation in load distribution.
Measured: 6 weeks
Foot Pressure Assessment - Center of Pressure (COP)
The pedobarographic system will measure center of pressure displacement during standing and walking. COP path characteristics provide objective indicators of stability and gait mechanics; greater displacement typically indicates reduced postural control.
Measured: 6 weeks
Balance Performance Assessment
Static and dynamic balance performance will be assessed using the Biodex Balance System. The system provides balance scores ranging from 0 to 12, where lower scores indicate better balance performance.
Measured: 6 weeks
Physical Activity Level Assessment
Physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ) - Short Form. Weekly metabolic equivalent of task (MET-minutes/week) will be calculated to classify physical activity as low, moderate, or high. Higher MET-minutes/week indicate higher physical activity levels.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start13 Oct 2025
- Primary completion15 Nov 2025
- Study completion7 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DiseasesStudies 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
- Investigator
- Enrolment
- 45 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
- NCT07260747
- Sponsor's protocol ID
- E-78097791-020-4737
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 3 Dec 2025
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Virtual Reality-Based Interventions on Foot Function, Foot Pressure, and Balance in Sedentary Individuals
- ClinicalTrials.gov ID
- NCT07260747
- Acronym / sponsor ID
- E-78097791-020-4737
- Conditions
- Foot Diseases
- Keywords
- exercise, foot
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 7 May 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
Comparison of the Effects of Virtual Reality-Based Interventions on Foot Function, Foot Pressure, and Balance in Sedentary Individuals
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR Biodex Group | Experimental | Other: VR Biodex GroupThis group will participate in a virtual reality-supported rehabilitation program integrated with the Biodex Balance System device. Participants will perform interactive balance and postural stability exercises through this system |
| Video-Based VR Group | Active comparator | Other: Video-Based VR GroupParticipants in this group will perform balance and foot exercises accompanied by exercise videos containing visual guidance. This intervention aims to provide the virtual reality experience through video-based content. |
| Control Group | Active comparator | Other: Control GroupThis group will follow a traditional home exercise program without any virtual reality intervention. This group will serve as a baseline for comparing the results of the other two groups |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sedentary Individual
- Individuals between the ages of 18-25
- Being a university student
Key exclusion criteria (4 listed)
- Athletes
- Individuals with orthopedic or neurological problems.
- Surgery history
- Cognitive impairment
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 |
|---|---|---|
| VR Biodex GroupThis group will participate in a virtual reality-supported rehabilitation program integrated with the Biodex Balance System device. | Other | VR Biodex Group |
| Video-Based VR Group: Participants in this group will perform balance and foot exercises accompanied by exercise videos containing visual guidance. | Other | Video-Based VR Group |
| Control GroupThis group will follow a traditional home exercise program without any virtual reality intervention. | Other | Control Group |
Primary outcome
Foot Function Assessment
Time frame: 6 weeks
Foot pain, disability, and activity limitation will be assessed using the Foot Function Index (FFI), a validated 23-item questionnaire. The total FFI score ranges from 0 to 100, with higher scores indicating worse foot function (greater pain, disability, and activity limitation).
Foot Pressure Assessment - Maximum Plantar Pressure
Time frame: 6 weeks
Plantar pressure during standing and walking will be assessed using a pedobarographic measurement system. Maximum plantar pressure will be recorded, with higher values indicating greater localized loading on the foot.
Foot Pressure Assessment - Contact Area
Time frame: 6 weeks
The pedobarographic system will measure the total plantar contact area during standing and walking. Larger contact area values indicate greater surface area participation in load distribution.
Foot Pressure Assessment - Center of Pressure (COP)
Time frame: 6 weeks
The pedobarographic system will measure center of pressure displacement during standing and walking. COP path characteristics provide objective indicators of stability and gait mechanics; greater displacement typically indicates reduced postural control.
Balance Performance Assessment
Time frame: 6 weeks
Static and dynamic balance performance will be assessed using the Biodex Balance System. The system provides balance scores ranging from 0 to 12, where lower scores indicate better balance performance.
Physical Activity Level Assessment
Time frame: 6 weeks
Physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ) - Short Form. Weekly metabolic equivalent of task (MET-minutes/week) will be calculated to classify physical activity as low, moderate, or high. Higher MET-minutes/week indicate higher physical activity levels.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Biodex Group and Video-Based VR Group in people with Foot Diseases, 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hazal GENÇ, PhD (05413204291, hazaloksuz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Function Assessment (time frame: 6 weeks). The study lists 6 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 3 Dec 2025.