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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Volunteers | Testing motor learning |
| |
| Vestibular hypofunction | Testing feasibility of rehabilitation game |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOR Test | Diagnostic Test | Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Normal volunteers and patients with vestibular hypofunction
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| Name | Affiliation | Role |
|---|---|---|
| Mark F. Walker, MD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106 | United States |
A limited set of de-identified data supporting published results will be made available on request, pursuant to a Data Use Agreement.
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Pursuant to Data Use Agreement
Pursuant to Data Use Agreement
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This measure applied only to Group 1: healthy individuals with intact vestibular function | Posted | Mean | 95% Confidence Interval | unitless gain ratio | 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. |
For the full duration of the study (4 years).
The procedure was to report adverse events to the local IRB.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Volunteers | Testing motor learning 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 |
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No conclusions can be made regarding the therapeutic efficacy of the computer game for treatment of vestibular hypofunction, because the study was not designed to test that. Instead, its objectives were, first, to test the game's ability to induce motor learning, to establish a physiological basis for therapeutic use, and, second, to test feasibility and playability by individuals with vestibular disorders.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Walker | VA Northeast Ohio Healthcare System | 216-791-3800 | 65229 | mark.walker5@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2023 | Nov 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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No biological specimens will be retained.
| Computer Game | Other | Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex |
|
| Nausea Scale | Other | Participants asked to rate their subjective nausea on a numeric scale after playing units of the computer game |
|
| Immediately after each 10-minute game block, median value calculated for each participant |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Dizziness Handicap Inventory | The Dizziness Handicap Inventory is a 25-item questionnaire that has a score range of 0-100. Higher scores mean worse dizziness. | Assessed only in participants with vestibular dysfunction | Mean | Standard Deviation | units on a scale |
|
| Activities-specific Balance Confidence scale | The Activities-Balance Confidence Scale is a 16-item questionnaire that assesses an individual's confidence in doing various activities that require balance. Each is given a percentage from 0% to 100% confidence in performing that activity. The number reported is the mean of these individual percentages. Higher numbers mean more confidence (better). | Assessed only in participants with vestibular dysfunction | Mean | Standard Deviation | units on a scale |
|
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| 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. | 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. | Posted | Median | Full Range | score on a scale | Immediately after each 10-minute game block, median value calculated for each participant |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Vestibular Hypofunction | Testing feasibility of rehabilitation game 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 Nausea Scale: Participants asked to rate their subjective nausea on a numeric scale after playing units of the computer game | 0 | 6 | 0 | 6 | 0 | 6 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|