Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Activities-specific Balance Confidence Scale (ABCS) Average Score |
The ABCS is a measure of balance-related confidence. The scale is made up of 16 questions for which respondents rate their level of perceived confidence in not becoming unsteady or falling. The average score ranges from 0 to 100 percent. Higher scores indicate greater balance-related confidence. The reliability and validity of the ABCS has been established in adults with and without a history of falling. |
Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5) |
|
Other |
Vestibular Activities and Participation Measure (VAPM) Average Score |
The VAPM is a 34-item questionnaire that is used to assess the impact of vestibular dysfunction on daily activities and participation in various life roles. The psychometrics for this tool have been established for adults with vestibular disorders. The average score ranges from 0 to 4. Higher scores indicate greater impact of vestibular symptoms on daily activities and participation in various life roles. |
Visit 1 (Week 1) and Visit 8 (Week 5) |
|
Other |
Vestibular Rehabilitation Benefits Questionnaire (VRBQ) Total Score at the End of the Trial |
The VRBQ was developed to assess outcomes from vestibular rehabilitation. The 22 questions are based on a literature review, participant interviews, and items from other measures. These questions are divided into three sub-scales: dizziness and anxiety (6), motion provoked dizziness (5), and quality of life (11). The total score ranges from 0-100 percent and scores > 0 percent indicate the presence of symptoms, functional loss, or decreased quality of life. See http://www.isvr.soton.ac.uk/audiology/vrbq.htm for more information regarding the scoring methodology. It has been validated against other measures. The VRBQ is designed to measure the difference between the participant's current state of symptoms and quality of life compared to a state that is normal for the individual. |
Visit 1 (Week 1) and Visit 8 (Week 5) |
|
Other |
Functional Gait Assessment (FGA) Total Score |
The FGA is a 10-item, observational, test of walking. Score for each item range from 0 to 3 and, thus, the total score ranges from 0 to 30. Use of an assistive device is permitted. Higher scores indicate greater stability during walking. The psychometrics of the FGA have been established for adults with balance disorders. |
Visit 1 (Week 1) and Visit 8 (Week 5) |
|
Other |
Walking Speed |
Gait speed has been shown to be a reliable and valid measure of functional balance in adults. Gait speed will be recorded during a 10-meter walk test. Participants will walk for 2-meters before entering and after exiting the 6-meter long recording section. A stopwatch will be used for timing. |
Visit 1 (Week 1) and Visit 8 (Week 5) |
|
Primary |
Rod and Disk Test (RDT) Mean Performance |
An image of a rod will be shown in the central portion of the visual field. The surrounding virtual environment will be void. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without any reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, the mean performance in this population is 0.39 (sd 0.8). Higher scores indicate subjective visual vertical alignment that is farther away from earth vertical. |
Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5) |
|
Primary |
Multisensory Balance Evaluation (MBE) as Measured by the Intersection Point Height |
This test is designed to assess balance during quiet standing in different sensory conditions. Participants perform one trial (lasting 30 seconds) of each condition. All trials are performed while standing on a force plate with the feet in a self-selected, comfortable position. The visual environment is controlled using an Oculus Rift. The surface conditions are either non-compliant or compliant. The frequency-dependent height of the Intersection Point (IP) of the ground reaction force is the main metric. The overall height of the IP curve obtained while the participant stands on a firm surface with their eyes open is the primary outcome. The height of IP ranges from 0 to 4.0, and higher values represent greater stability. |
Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5) |
|
Primary |
Subjective Visual Vertical (SVV) Mean Performance |
An image of a rod will be shown in the central portion of the visual field. The surrounding virtual environment will be void. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without any reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, the mean performance in this population is 0.39 (sd 0.8). Higher scores indicate subjective visual vertical alignment that is farther away from earth vertical. |
Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5) |
|
Primary |
Rod and Frame Test (RFT) Mean Performance |
An image of a rod will be projected inside a tilted frame within the central portion of the visual field. The surrounding virtual environment will be void. The frame will be tilted by +/- 20° in the frontal plane. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, mean performance in this population is 6.51 (sd 7.8). Higher values indicate greater deviations of perceived vertical from earth vertical. |
Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5) |
|
Secondary |
Vision-related Dizziness Questionnaire (VRDQ) Total Score |
The VRDQ is used to quantify vision-related dizziness. This outcome measure consists of 25 questions comprising two subscales [frequency and severity of symptoms]. The range of scores for each sub-scale is 0 to 100 points. The total score is the average of both sub-scales. Higher scores represent greater frequency and severity of symptoms. Test-retest reliability for the VRDQ is well above the good performance level and convergent validity for the VRDQ was demonstrated with the Dizziness Handicap Inventory (DHI). Spearman correlation coefficients are 0.75 between the DHI and VRDQ frequency scale and 0.76 between the DHI and VRDQ severity scale. |
Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5) |
|
Secondary |
Dizziness Handicap Inventory (DHI) Total Score |
The DHI is used to assess the severity of self-perceived disability secondary to dizziness. The tool is comprised of 25 questions which are score as yes = 4 points, sometimes = 2 points, and no = 0 points. The total score has a range of 0 to 100 points. The reliability and validity of the DHI have been established. |
Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5) |
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