Trial Outcomes & Findings for Virtual Environments for Vestibular Rehabilitation (NCT NCT04268745)
NCT ID: NCT04268745
Last Updated: 2023-12-15
Results Overview
The Visual Vertigo Analogue Scale (VVAS) is a self-reported questionnaire where a participant rates their visual vertigo on a 10 cm line in 9 different visually challenging environments. A score of 0 indicates no dizziness. Maximal score is 100 (calculated as the measurement on each item X 9 divided by 10). A higher score indicates worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
baseline and 8 weeks
Results posted on
2023-12-15
Participant Flow
Participant milestones
| Measure |
Virtual Reality
Progressive immersive training with the virtual reality app Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning 8 weeks, 1 visit per week, 30 minutes long In home: Gait and balance exercises, No exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Balance training: Progressive balance training within virtual environments
|
Traditional Vestibular Rehabilitation
Progressive gait, gaze stability and balance exercises Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.
Balance: standing balance tasks, progress with BOS (wide to narrow to tandem), support surface, eyes closed, duration, head turns.
8 weeks, 1 visit per week, 30 minutes long In home: Gait, gaze stability and balance exercises, including exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Traditional Vestibular Rehabilitation: Progressive balance training and gaze stability exercises
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Virtual Reality
Progressive immersive training with the virtual reality app Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning 8 weeks, 1 visit per week, 30 minutes long In home: Gait and balance exercises, No exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Balance training: Progressive balance training within virtual environments
|
Traditional Vestibular Rehabilitation
Progressive gait, gaze stability and balance exercises Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.
Balance: standing balance tasks, progress with BOS (wide to narrow to tandem), support surface, eyes closed, duration, head turns.
8 weeks, 1 visit per week, 30 minutes long In home: Gait, gaze stability and balance exercises, including exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Traditional Vestibular Rehabilitation: Progressive balance training and gaze stability exercises
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Death in the family
|
1
|
0
|
Baseline Characteristics
Virtual Environments for Vestibular Rehabilitation
Baseline characteristics by cohort
| Measure |
Virtual Reality
n=15 Participants
Progressive immersive training with the virtual reality app Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning 8 weeks, 1 visit per week, 30 minutes long In home: Gait and balance exercises, No exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Balance training: Progressive balance training within virtual environments
|
Traditional Vestibular Rehabilitation
n=15 Participants
Progressive gait, gaze stability and balance exercises Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.
Balance: standing balance tasks, progress with BOS (wide to narrow to tandem), support surface, eyes closed, duration, head turns.
8 weeks, 1 visit per week, 30 minutes long In home: Gait, gaze stability and balance exercises, including exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Traditional Vestibular Rehabilitation: Progressive balance training and gaze stability exercises
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.33 years
STANDARD_DEVIATION 15.35 • n=5 Participants
|
50.43 years
STANDARD_DEVIATION 18.79 • n=7 Participants
|
47.79 years
STANDARD_DEVIATION 16.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Dizziness Handicap Inventory
|
53.07 units on a scale
STANDARD_DEVIATION 16.42 • n=5 Participants
|
50.43 units on a scale
STANDARD_DEVIATION 18.79 • n=7 Participants
|
51.93 units on a scale
STANDARD_DEVIATION 17.99 • n=5 Participants
|
|
Diagnoses
Peripheral Hypofunction
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Diagnoses
Post Concussion
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Diagnoses
Vestibular Migraine
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Diagnoses
Acoustic Neuroma
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Head Thrust
Abnormal
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Head Thrust
Normal
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Head Thrust
NA
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Head Shaking
Abnormal
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Head Shaking
Normal
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Head Shaking
NA
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Gaze evoked nystagmus without fixation
Abnormal
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Gaze evoked nystagmus without fixation
Normal
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Gaze evoked nystagmus without fixation
NA
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Calorics via VNG Videonystagmography
Normal
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Calorics via VNG Videonystagmography
Weakness
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Calorics via VNG Videonystagmography
NA
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Onset in Years
|
2.53 years
STANDARD_DEVIATION 3.98 • n=5 Participants
|
0.9 years
STANDARD_DEVIATION 0.76 • n=7 Participants
|
1.74 years
STANDARD_DEVIATION 2.98 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 8 weeksThe Visual Vertigo Analogue Scale (VVAS) is a self-reported questionnaire where a participant rates their visual vertigo on a 10 cm line in 9 different visually challenging environments. A score of 0 indicates no dizziness. Maximal score is 100 (calculated as the measurement on each item X 9 divided by 10). A higher score indicates worse outcome.
Outcome measures
| Measure |
Virtual Reality
n=8 Participants
Progressive immersive training with the virtual reality app Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning 8 weeks, 1 visit per week, 30 minutes long In home: Gait and balance exercises, No exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Balance training: Progressive balance training within virtual environments
|
Traditional Vestibular Rehabilitation
n=10 Participants
Progressive gait, gaze stability and balance exercises Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.
Balance: standing balance tasks, progress with BOS (wide to narrow to tandem), support surface, eyes closed, duration, head turns.
8 weeks, 1 visit per week, 30 minutes long In home: Gait, gaze stability and balance exercises, including exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Traditional Vestibular Rehabilitation: Progressive balance training and gaze stability exercises
|
|---|---|---|
|
Visual Vertigo Analog Scale (VVAS)
Pre - Intervention
|
43.05 score on a scale
Interval 30.93 to 55.17
|
36.84 score on a scale
Interval 24.72 to 48.97
|
|
Visual Vertigo Analog Scale (VVAS)
Post - Intervention
|
31.28 score on a scale
Interval 14.59 to 47.97
|
21.41 score on a scale
Interval 6.51 to 36.31
|
PRIMARY outcome
Timeframe: baseline and 8 weeksA functional test designed to assess individual's ability to perform various motor tasks, such as: walking with eyes closed, walking backwards, climbing stairs. There are 10 items, each is scored by a therapist on a scale of 0 (severe impairment) to 3 (normal). Maximal score is 30. Higher is better.
Outcome measures
| Measure |
Virtual Reality
n=8 Participants
Progressive immersive training with the virtual reality app Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning 8 weeks, 1 visit per week, 30 minutes long In home: Gait and balance exercises, No exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Balance training: Progressive balance training within virtual environments
|
Traditional Vestibular Rehabilitation
n=10 Participants
Progressive gait, gaze stability and balance exercises Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.
Balance: standing balance tasks, progress with BOS (wide to narrow to tandem), support surface, eyes closed, duration, head turns.
8 weeks, 1 visit per week, 30 minutes long In home: Gait, gaze stability and balance exercises, including exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Traditional Vestibular Rehabilitation: Progressive balance training and gaze stability exercises
|
|---|---|---|
|
Functional Gait Analysis (FGA)
Pre - Intervention
|
20.43 score on a scale
Interval 18.43 to 22.52
|
21.07 score on a scale
Interval 19.05 to 23.08
|
|
Functional Gait Analysis (FGA)
Post - Intervention
|
26.35 score on a scale
Interval 23.61 to 29.1
|
27.95 score on a scale
Interval 25.5 to 30.41
|
PRIMARY outcome
Timeframe: baseline and 8 weeksThe DHI has 25 items and each item is scored as 'no', 'sometimes' or 'yes' to evaluate self-perceived disability imposed by dizziness. The minimum score is 0 and the maximum score is 100, a higher score indicates increased perceived disability. The scale is no = 0, sometimes = 2, and yes = 4.
Outcome measures
| Measure |
Virtual Reality
n=8 Participants
Progressive immersive training with the virtual reality app Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning 8 weeks, 1 visit per week, 30 minutes long In home: Gait and balance exercises, No exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Balance training: Progressive balance training within virtual environments
|
Traditional Vestibular Rehabilitation
n=10 Participants
Progressive gait, gaze stability and balance exercises Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.
Balance: standing balance tasks, progress with BOS (wide to narrow to tandem), support surface, eyes closed, duration, head turns.
8 weeks, 1 visit per week, 30 minutes long In home: Gait, gaze stability and balance exercises, including exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Traditional Vestibular Rehabilitation: Progressive balance training and gaze stability exercises
|
|---|---|---|
|
The Dizziness Handicap Inventory (DHI)
|
53.07 score on a scale
Interval 43.47 to 62.76
|
50.8 score on a scale
Interval 41.1 to 60.49
|
SECONDARY outcome
Timeframe: baseline and 8 weeksA 16 item subjective measure of confidence in performing activities without falling. Each item is scored from 0% (no confidence in one's balance) to 100% (full confidence in one's balance). Total score is taken by dividing total by 16. A higher score indicates better balance confidence.
Outcome measures
| Measure |
Virtual Reality
n=8 Participants
Progressive immersive training with the virtual reality app Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning 8 weeks, 1 visit per week, 30 minutes long In home: Gait and balance exercises, No exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Balance training: Progressive balance training within virtual environments
|
Traditional Vestibular Rehabilitation
n=10 Participants
Progressive gait, gaze stability and balance exercises Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.
Balance: standing balance tasks, progress with BOS (wide to narrow to tandem), support surface, eyes closed, duration, head turns.
8 weeks, 1 visit per week, 30 minutes long In home: Gait, gaze stability and balance exercises, including exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Traditional Vestibular Rehabilitation: Progressive balance training and gaze stability exercises
|
|---|---|---|
|
The Activities Balance Confidence Scale
Post Intervention
|
82.89 score on a scale
Interval 70.46 to 95.31
|
79.78 score on a scale
Interval 68.41 to 91.14
|
|
The Activities Balance Confidence Scale
Pre Intervention
|
71.34 score on a scale
Interval 61.52 to 81.16
|
74.21 score on a scale
Interval 64.39 to 84.03
|
SECONDARY outcome
Timeframe: baseline and 8 weeksPatients are asked to rise up from a chair, walk at their comfortable speed 10 feet, turn around a cone, walk back and sit down. The faster performance out of two trials was recorded.
Outcome measures
| Measure |
Virtual Reality
n=8 Participants
Progressive immersive training with the virtual reality app Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning 8 weeks, 1 visit per week, 30 minutes long In home: Gait and balance exercises, No exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Balance training: Progressive balance training within virtual environments
|
Traditional Vestibular Rehabilitation
n=10 Participants
Progressive gait, gaze stability and balance exercises Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.
Balance: standing balance tasks, progress with BOS (wide to narrow to tandem), support surface, eyes closed, duration, head turns.
8 weeks, 1 visit per week, 30 minutes long In home: Gait, gaze stability and balance exercises, including exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Traditional Vestibular Rehabilitation: Progressive balance training and gaze stability exercises
|
|---|---|---|
|
Timed-Up and Go
Pre - Intervention
|
7.97 seconds
Interval 7.02 to 8.92
|
7.77 seconds
Interval 6.87 to 8.67
|
|
Timed-Up and Go
Post - Intervention
|
7.93 seconds
Interval 6.88 to 8.98
|
8.03 seconds
Interval 7.08 to 8.98
|
SECONDARY outcome
Timeframe: baseline and 8 weeksA multidirectional stepping test of dynamic balance and coordination. Participants are asked to step over 4 canes on the floor in a clockwise and then counterclockwise direction while being timed. Patients did one practice trial and then we recorded the faster performance out of two trials.
Outcome measures
| Measure |
Virtual Reality
n=8 Participants
Progressive immersive training with the virtual reality app Scenes: start from most salient to the patient, eventually do all Duration: start at 60 seconds, increase over time up to 3 minutes per scene Complexity: start minimal, gradually increase up to most complex Tasks: standing with diverse base of support (BOS), head turns (progress with speed, planes); stepping, turning 8 weeks, 1 visit per week, 30 minutes long In home: Gait and balance exercises, No exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Balance training: Progressive balance training within virtual environments
|
Traditional Vestibular Rehabilitation
n=10 Participants
Progressive gait, gaze stability and balance exercises Gait: walking with head turns, progress with range, speed and planes of head movement; change of walking BOS: wide, normal, tandem Gaze: focus on a target while moving head side to side / up down. Progress with speed, duration, busier background, standing to walking.
Balance: standing balance tasks, progress with BOS (wide to narrow to tandem), support surface, eyes closed, duration, head turns.
8 weeks, 1 visit per week, 30 minutes long In home: Gait, gaze stability and balance exercises, including exercises with eyes closed, 8 weeks, 6 times per week, twice per day, 10 minutes long
Traditional Vestibular Rehabilitation: Progressive balance training and gaze stability exercises
|
|---|---|---|
|
The Four-Step Square Test
Pre- Intervention
|
11.49 seconds
Interval 9.43 to 13.55
|
9.48 seconds
Interval 7.52 to 11.44
|
|
The Four-Step Square Test
Post- Intervention
|
10.29 seconds
Interval 7.96 to 12.63
|
9.65 seconds
Interval 7.54 to 11.75
|
Adverse Events
Virtual Reality
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Traditional Vestibular Rehabilitation
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