Trial Outcomes & Findings for Sensory Training for Visual Motion Sickness (NCT NCT04420949)
NCT ID: NCT04420949
Last Updated: 2023-06-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
Results posted on
2023-06-15
Participant Flow
Participant milestones
| Measure |
Healthy
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
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|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sensory Training for Visual Motion Sickness
Baseline characteristics by cohort
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Total
n=10 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
41.02 years
STANDARD_DEVIATION 16.14 • n=5 Participants
|
43.12 years
STANDARD_DEVIATION 16.78 • n=7 Participants
|
42.07 years
STANDARD_DEVIATION 15.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Visual Vertigo Analog Scale (VVAS)
|
0 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
163.4 units on a scale
STANDARD_DEVIATION 150.8 • n=7 Participants
|
81.7 units on a scale
STANDARD_DEVIATION 132 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
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|---|---|---|
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Rod and Disk Test (RDT) Mean Performance
Visit 1
|
17 degrees
Standard Deviation 7.5
|
13.3 degrees
Standard Deviation 4
|
|
Rod and Disk Test (RDT) Mean Performance
Visit 2
|
7.8 degrees
Standard Deviation 8.8
|
12.1 degrees
Standard Deviation 6.7
|
|
Rod and Disk Test (RDT) Mean Performance
Visit 7
|
12.4 degrees
Standard Deviation 6.7
|
10.3 degrees
Standard Deviation 4.4
|
|
Rod and Disk Test (RDT) Mean Performance
Visit 8
|
12.6 degrees
Standard Deviation 5.3
|
10.3 degrees
Standard Deviation 7
|
PRIMARY outcome
Timeframe: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
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|---|---|---|
|
Multisensory Balance Evaluation (MBE) as Measured by the Intersection Point Height
Visit 1
|
0.5 meters
Standard Deviation 0.23
|
0.53 meters
Standard Deviation 0.17
|
|
Multisensory Balance Evaluation (MBE) as Measured by the Intersection Point Height
Visit 2
|
0.42 meters
Standard Deviation 0.18
|
0.52 meters
Standard Deviation 0.15
|
|
Multisensory Balance Evaluation (MBE) as Measured by the Intersection Point Height
Visit 7
|
0.37 meters
Standard Deviation 0.17
|
0.39 meters
Standard Deviation 0.08
|
|
Multisensory Balance Evaluation (MBE) as Measured by the Intersection Point Height
Visit 8
|
0.46 meters
Standard Deviation 0.15
|
0.37 meters
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
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|---|---|---|
|
Subjective Visual Vertical (SVV) Mean Performance
Visit 2
|
-1.14 degrees
Standard Deviation 1.36
|
-1.4 degrees
Standard Deviation 1.86
|
|
Subjective Visual Vertical (SVV) Mean Performance
Visit 1
|
-1.34 degrees
Standard Deviation 1.65
|
-1.3 degrees
Standard Deviation 3.76
|
|
Subjective Visual Vertical (SVV) Mean Performance
Visit 7
|
-.21 degrees
Standard Deviation 0.5
|
-1.96 degrees
Standard Deviation 1.17
|
|
Subjective Visual Vertical (SVV) Mean Performance
Visit 8
|
1.0 degrees
Standard Deviation 1.85
|
-2.22 degrees
Standard Deviation 2.08
|
PRIMARY outcome
Timeframe: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
|---|---|---|
|
Rod and Frame Test (RFT) Mean Performance
Visit 1
|
3.9 degrees
Standard Deviation 4.9
|
7.9 degrees
Standard Deviation 2.9
|
|
Rod and Frame Test (RFT) Mean Performance
Visit 2
|
5.7 degrees
Standard Deviation 4.3
|
7.2 degrees
Standard Deviation 3.3
|
|
Rod and Frame Test (RFT) Mean Performance
Visit 7
|
5.6 degrees
Standard Deviation 1.7
|
8.2 degrees
Standard Deviation 6.1
|
|
Rod and Frame Test (RFT) Mean Performance
Visit 8
|
7.6 degrees
Standard Deviation 1.9
|
5.9 degrees
Standard Deviation 3.45
|
SECONDARY outcome
Timeframe: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
|---|---|---|
|
Vision-related Dizziness Questionnaire (VRDQ) Total Score
Visit 1
|
0 units on a scale
Standard Deviation 0
|
90.8 units on a scale
Standard Deviation 90
|
|
Vision-related Dizziness Questionnaire (VRDQ) Total Score
Visit 2
|
0 units on a scale
Standard Deviation 0
|
86 units on a scale
Standard Deviation 80
|
|
Vision-related Dizziness Questionnaire (VRDQ) Total Score
Visit 7
|
0 units on a scale
Standard Deviation 0
|
74 units on a scale
Standard Deviation 103
|
|
Vision-related Dizziness Questionnaire (VRDQ) Total Score
Visit 8
|
0 units on a scale
Standard Deviation 0
|
76 units on a scale
Standard Deviation 76
|
SECONDARY outcome
Timeframe: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
|---|---|---|
|
Dizziness Handicap Inventory (DHI) Total Score
Visit 1
|
0.4 units on a scale
Standard Deviation 0.9
|
19.2 units on a scale
Standard Deviation 22
|
|
Dizziness Handicap Inventory (DHI) Total Score
Visit 2
|
0.4 units on a scale
Standard Deviation 0.9
|
24.4 units on a scale
Standard Deviation 22.4
|
|
Dizziness Handicap Inventory (DHI) Total Score
Visit 7
|
1 units on a scale
Standard Deviation 2
|
23 units on a scale
Standard Deviation 27
|
|
Dizziness Handicap Inventory (DHI) Total Score
Visit 8
|
0.8 units on a scale
Standard Deviation 1.1
|
18.4 units on a scale
Standard Deviation 24.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
|---|---|---|
|
Activities-specific Balance Confidence Scale (ABCS) Average Score
Visit 1
|
99 percent
Standard Deviation 0.8
|
91.8 percent
Standard Deviation 10
|
|
Activities-specific Balance Confidence Scale (ABCS) Average Score
Visit 2
|
99 percent
Standard Deviation 1
|
88 percent
Standard Deviation 15
|
|
Activities-specific Balance Confidence Scale (ABCS) Average Score
Visit 7
|
99 percent
Standard Deviation 1.3
|
93.5 percent
Standard Deviation 7.6
|
|
Activities-specific Balance Confidence Scale (ABCS) Average Score
Visit 8
|
99 percent
Standard Deviation 0.7
|
95.6 percent
Standard Deviation 6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Week 1) and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
|---|---|---|
|
Vestibular Activities and Participation Measure (VAPM) Average Score
Visit 1
|
0 units on a scale
Standard Deviation 0
|
0.84 units on a scale
Standard Deviation 0.79
|
|
Vestibular Activities and Participation Measure (VAPM) Average Score
Visit 8
|
0 units on a scale
Standard Deviation 0
|
0.33 units on a scale
Standard Deviation 0.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Week 1) and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
|---|---|---|
|
Vestibular Rehabilitation Benefits Questionnaire (VRBQ) Total Score at the End of the Trial
Visit 1
|
5.4 percent
Standard Deviation 3.8
|
27.8 percent
Standard Deviation 27.7
|
|
Vestibular Rehabilitation Benefits Questionnaire (VRBQ) Total Score at the End of the Trial
Visit 8
|
2 percent
Standard Deviation 2.5
|
20.2 percent
Standard Deviation 28.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Week 1) and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
|---|---|---|
|
Functional Gait Assessment (FGA) Total Score
Visit 1
|
28.8 units on a scale
Standard Deviation 1.6
|
29 units on a scale
Standard Deviation 1.7
|
|
Functional Gait Assessment (FGA) Total Score
Visit 8
|
29.6 units on a scale
Standard Deviation 0.89
|
29.3 units on a scale
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Week 1) and Visit 8 (Week 5)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.
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
Vestibular-impaired
n=5 Participants
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
Sensory re-weighting: During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
|
|---|---|---|
|
Walking Speed
Visit 1
|
2.14 meters per second
Standard Deviation 0.20
|
2.05 meters per second
Standard Deviation 0.46
|
|
Walking Speed
Visit 8
|
2.17 meters per second
Standard Deviation 0.27
|
2.17 meters per second
Standard Deviation 0.18
|
Adverse Events
Healthy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vestibular-impaired
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place