Effectiveness of VestAid App

BlueHalo

Status: Not yet enrolling

Conditions: Vestibular Disorders; Balance Deficits; Dizziness; Vestibular Disease; MTBI - Mild Traumatic Brain Injury

Treatments: Other: Standard of care vestibular rehabilitation; Device: Vestibular Rehabilitation Aid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06683417

STUDY24060038

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Snellen visual acuity (corrected) greater than 20/40
• No more than 25dB hearing loss at 500,1000, 2000, and 4000 Hz
• Ability to detect 4.31 using Semmes-Weinstein monofilament at the lower extremity
• At least 40 degrees of neck yaw motion with only mild to moderate pain (6 or under on 0-10 numeric pain scale)
• Internet access at home
• No significant residual from past musculoskeletal or neuromuscular conditions
• Ability ambulates unassisted
• Diagnosed with a concussion or inner ear problem the last 30 days
• Between 18-60 years of age
• Can read and understand English
• Has complaints of dizziness

Exclusion criteria:

• Greater then 30 days since diagnosis of concussion/mTBI or inner ear problem
• No access to internet at home
• Younger than 18 years of age or older than 60 years of age
• Cannot read or understand English
• No complaints of dizziness and/or balance deficits
• Have significant neuropathy
• Cannot see tablet clearly at 1 meter
• Neck pain >5 on a 10-point pain scale.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

VestAid

Experimental group

Description:

Use of VestAid tablet application to aid vestibular rehabilitation

Treatment:

Device: Vestibular Rehabilitation Aid

Standard of Care vestibular rehabilitation

Active Comparator group

Description:

Use of standard of care vestibular rehabilitation

Treatment:

Other: Standard of care vestibular rehabilitation