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Computerized Vestibular Rehabilitation

Computerized Game-based Vestibular Rehabilitation: Assessment of Feasibility and Motor Learning

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03589859
Enrollment
24
Registered
2018-07-18
Start date
2018-12-01
Completion date
2022-11-30
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Diseases

Keywords

neurologic rehabilitation, computer games

Brief summary

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.

Interventions

DIAGNOSTIC_TESTVOR Test

Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.

Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex

OTHERNausea Scale

Participants asked to rate their subjective nausea on a numeric scale after playing units of the computer game

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* GROUP 1: Healthy volunteers: Static visual acuity of at least 20/30 at testing distance * GROUP 2: Vestibular patients: Unilateral or bilateral vestibular hypofunction, No central vestibular disorder, Static Visual Acuity of at least 20/30 at testing distance

Exclusion criteria

* GROUP 1: Peripheral or central vestibular disorder * GROUP 2: Central vestibular disorder

Design outcomes

Primary

MeasureTime frameDescription
Vestibulo-ocular Reflex Gain RatioVOR 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 head movement) is better with respect to the training goal, but it is not better with respect to real-world visual function, for which a gain of one is the goal. There is no threshold value for this type of motor learning experiment. Instead, the question is whether the gain is increased after training, and if so, by what percentage relative to the training goal.

Other

MeasureTime frameDescription
Nausea ScaleImmediately after each 10-minute game block, median value calculated for each participantParticipants 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Normal Volunteers
Healthy individuals with intact vestibular function VOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head. Computer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
18
Vestibular Hypofunction
Veterans with peripheral vestibular hypofunction VOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head. Computer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
6
Total24

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject06

Baseline characteristics

CharacteristicTotalVestibular HypofunctionNormal Volunteers
Activities-specific Balance Confidence scale79.5 units on a scale
STANDARD_DEVIATION 14
79.5 units on a scale
STANDARD_DEVIATION 14
Age, Continuous42 years
STANDARD_DEVIATION 17
61 years
STANDARD_DEVIATION 15
35 years
STANDARD_DEVIATION 13
Dizziness Handicap Inventory31.6 units on a scale
STANDARD_DEVIATION 16.7
31.6 units on a scale
STANDARD_DEVIATION 16.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
22 Participants6 Participants16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
19 Participants5 Participants14 Participants
Region of Enrollment
United States
24 Participants6 Participants18 Participants
Sex: Female, Male
Female
9 Participants0 Participants9 Participants
Sex: Female, Male
Male
15 Participants6 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 6
other
Total, other adverse events
0 / 180 / 6
serious
Total, serious adverse events
0 / 180 / 6

Outcome results

Primary

Vestibulo-ocular Reflex Gain Ratio

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 head movement) is better with respect to the training goal, but it is not better with respect to real-world visual function, for which a gain of one is the goal. There is no threshold value for this type of motor learning experiment. Instead, the question is whether the gain is increased after training, and if so, by what percentage relative to the training goal.

Time frame: 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.

Population: This measure applied only to Group 1: healthy individuals with intact vestibular function

ArmMeasureValue (MEAN)
Normal VolunteersVestibulo-ocular Reflex Gain Ratio1.15 unitless gain ratio
Comparison: A linear mixed effects model was used to compare pre- and post-training VOR gainsp-value: <0.001Mixed Models Analysis
Other Pre-specified

Nausea Scale

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.

Time frame: Immediately after each 10-minute game block, median value calculated for each participant

Population: This measure applied only to Group 2: participants with vestibular dysfunction. Of the 6 enrolled participants in this group, one chose not to complete the game playing after consenting, and a second was found to have recovery of his vestibular function before game playing. The reported data are from the remaining four participants.

ArmMeasureValue (MEDIAN)
Vestibular HypofunctionNausea Scale1.2 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026