NCT03589859

Computerized Vestibular Rehabilitation

Completed Results posted Last updated 26 November 2024

What this trial tests

trial testing VOR Test in Vestibular Diseases in 24 participants. Completed in 30 November 2022.

Timeline

1 December 2018

Primary endpoint
30 November 2022

30 November 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Status	Completed
Study type	OBSERVATIONAL
Enrollment	24
Start date	1 December 2018
Primary completion	30 November 2022
Estimated completion	30 November 2022
Sites	1 location across United States

Drugs / interventions tested

• VOR Test
• Computer Game
• Nausea Scale

Conditions studied

• Vestibular Diseases — all drugs for Vestibular Diseases →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 75, any sex, with Vestibular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Vestibulo-ocular Reflex Gain Ratio Primary · VOR measurements to determine gain were performed immediately before and after each approximately 30 minute training session. Pre- and post-training gains were then combined in the VOR gain ratio to determine the training effect.

The vestibulo-ocular reflex gain is the relationship between a rotation of the head and the evoked eye movement. The outcome measure is the ratio of the VOR gain after training to that before training. VOR gain is determined by a scaled fit of eye speed to evoking head speed (normal gain is 1). Note that this experiment was not a treatment of impairment but a test of the ability of the vestibular game to elicit motor learning (away from normal) in individuals with intact motor learning. In that context, an increase in the gain to a value greater than unity (faster eye movement relative to the

Group	Value	95% CI
Normal Volunteers	1.15	1.10 – 1.20

Nausea Scale Secondary · Immediately after each 10-minute game block, median value calculated for each participant

Participants with vestibular hypofunction rated their nausea after each game block on a scale of 1 to 10. For each visit, there were up to 3 game-blocks, each of 10-minutes duration. The number of blocks was determined by the participant. A higher score is a worse outcome (more nausea). The average nausea scale rating was determined for each participant. The final result is the median of these averaged scores.

Group	Value	95% CI
Vestibular Hypofunction	1.2	0 – 4.5

Sponsor's own description

Disorders of vestibular function and balance are an important component of many conditions that commonly affect veterans, such as inner ear diseases, diabetes, and traumatic brain injury. Veterans with vestibular impairment have reduced quality of life, limitations on work and physical activities, and an increased risk of falls. The goal of this research is to develop a more engaging and effective interactive tool for vestibular rehabilitation to improve the lives of affected veterans. The first steps in this process will be to test the ability of the application to facilitate vestibular learning and to test its feasibility in vestibular patients. The hypothesis is that computer-game-based adaptation will induce robust VOR motor learning and will provide an engaging platform for vestibular rehabilitation. Ultimately, our application has the potential to provide more flexible vestibular exercises that will allow therapy to be customized for each patient. It will also have the ability to track a patient's progress over time and to advance exercises as function improves.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.