NCT06683417

Effectiveness of VestAid App

Vestibular Rehabilitation Aid (VestAid)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: BlueHalo · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation exercises.

Conditions

• MTBI - Mild Traumatic Brain Injury
• Vestibular Disease
• Balance Deficits
• Vestibular Disorders
• Dizziness

Interventions

Type	Name	Description
DEVICE	Vestibular Rehabilitation Aid	The tablet-based VestAid system was developed to repair, restore and maintain vestibular-ocular function that is impaired in patients post-mTBI. Each participant\'s treating physical therapist will develop their own personalized exercise prescription. The physical therapist will be asked to recommend that the patients complete a home exercise program at least 2-3 times per day for 6 weeks. The exercise prescription will be placed on the VestAid by the physical therapist for the patient to follow. The patient is not able to modify the exercise, only the physical therapist can modify the exercises. Exercises will be modified based on patient\'s response and symptom reports. The physical therapist and study coordinator will receive an alert on the VestAid online dashboard if the patient\'s symptoms are greater than or equal to 8/10.
OTHER	Standard of care vestibular rehabilitation	Vestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades

Timeline

• Start date: 2025-01-15
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study