NCT07260747

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2026

Completed
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

November 14, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

exercisefoot

Outcome Measures

Primary Outcomes (6)

  • 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).

    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.

    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.

    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.

    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.

    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.

    6 weeks

Study Arms (3)

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

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.

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

Other: Control Group

Interventions

: Participants in this group will perform balance and foot exercises accompanied by exercise videos containing visual guidance.

Video-Based VR Group

This group will follow a traditional home exercise program without any virtual reality intervention.

Control Group

This group will participate in a virtual reality-supported rehabilitation program integrated with the Biodex Balance System device.

VR Biodex Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahceşehir University Health Center

Istanbul, 34070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Foot DiseasesMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Hazal GENÇ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 3, 2025

Study Start

October 13, 2025

Primary Completion

November 15, 2025

Study Completion

May 7, 2026

Last Updated

December 3, 2025

Record last verified: 2025-12

Locations