Clinical research targeting sedentary individuals is breaking new ground with a study exploring the effects of virtual reality (VR) interventions on foot function, foot pressure, and balance. Sponsored by Istanbul Medipol University Hospital, this study offers new perspectives on the potential of VR technologies in addressing foot diseases—a critical area of interest for researchers, clinicians, and regulators.
What changed?
The study, now recruiting participants as of December 3, 2025, aims to assess whether using VR-based technologies can enhance foot health and stability compared to traditional methods or no intervention at all. With conditions like foot diseases affecting quality of life globally, this research places a strong focus on effective, non-invasive treatment options.
How is the study designed?
The trial includes three groups:
- VR Biodex Group: Participants utilize immersive VR environments designed to test balance and responsiveness, supported by Biodex systems.
- Video-Based VR Group: Individuals engage with non-immersive VR formats via video interfaces targeting coordination and sensory functions.
- Control Group: No active intervention is applied, serving as a baseline for comparison.
By carefully evaluating foot pressure changes, functional improvements, and balance parameters across these cohorts, the trial seeks regulatory-grade evidence that could influence future device development and approvals.
How does VR technology fit within regulatory frameworks?
Under MDR Annex XIV (General Requirements for Clinical Investigations), this study demonstrates a clear focus on safety, performance, and intended purpose for VR health technologies. Results could reshape guidelines for medical device manufacturers combining software and hardware components designed for rehabilitation.
What are the clinical implications?
Foot diseases, often stemming from inactivity, carry risks such as poor circulation and reduced balance. With VR playing a growing role in rehabilitation, findings may show:
- Direct benefits on postural control through interactive feedback mechanisms.
- Reduction in injury risks associated with sedentary lifestyles.
- Potential cost-effectiveness compared to traditional physiotherapy sessions.
Healthcare teams performing clinical evaluations and policy decisions could adopt VR interventions as alternatives to conventional treatments where evidence supports measurable therapeutic benefits.
Are there scalable opportunities for VR integration?
Data generated from this trial could open pathways for scalable implementation in treatment programs tailored to sedentary populations, while addressing gaps in accessibility and compliance rates within traditional rehabilitation methods.
FAQs about VR in clinical trials
1. Is VR safe for therapeutic use?
When designed and tested within regulated frameworks, VR technologies can be safe and effective, meeting MDR standards.
2. Who should consider VR trials as a treatment option?
Patients with reduced activity levels or chronic conditions affecting foot function may benefit. Consultation with healthcare providers is advised.
3. What role do control groups play in VR trials?
Control groups provide essential data for comparing intervention outcomes against non-treatment baselines.
Final thoughts
This recruitment phase marks an exciting step in evaluating next-generation tools for addressing critical health challenges. With VR technologies emerging as multifaceted intervention platforms, stakeholders—from clinicians to policymakers—should monitor ongoing research outcomes closely.
Disclaimer
This content is intended for informational purposes only. It does not constitute legal advice or replace clinical decision-making guidelines. Consult the relevant regulatory authority for official guidance.
Study details and link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07260747?term=medical+device