Comparison of the Effects of Virtual Reality-Based Interventions on Foot Function, Foot Pressure, and Balance in Sedentary Individuals

December 2, 2025 updated by: hazal genc, Istanbul Medipol University Hospital
Comparison of the Effects of Virtual Reality-Based Interventions on Foot Function, Foot Pressure, and Balance in Sedentary Individuals

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

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 Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34070
        • Recruiting
        • Bahceşehir University Health Center
        • Contact:
          • HAZAL genç, phd

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

Yes

Description

Inclusion Criteria:

  • Sedentary Individual
  • Individuals between the ages of 18-25
  • Being a university student

Exclusion Criteria:

  • Athletes
  • Individuals with orthopedic or neurological problems.
  • Surgery history
  • Cognitive impairment

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: VR Biodex Group
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
Other: VR Biodex Group
This group will participate in a virtual reality-supported rehabilitation program integrated with the Biodex Balance System device.
Active Comparator: Video-Based VR Group
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.
Other: Video-Based VR Group
: Participants in this group will perform balance and foot exercises accompanied by exercise videos containing visual guidance.
Active Comparator: Control Group
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
Other: Control Group
This group will follow a traditional home exercise program without any virtual reality intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

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)

October 13, 2025

Primary Completion (Actual)

November 15, 2025

Study Completion (Estimated)

May 7, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-78097791-020-4737

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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