Trial Outcomes & Findings for Dose of Vestibular Rehabilitation for Vestibular Hypofunction (NCT NCT04851184)
NCT ID: NCT04851184
Last Updated: 2025-12-17
Results Overview
Final score on the Dizziness Handicap Inventory. The Dizziness Handicap Inventory (DHI) is a 25-item questionnaire used to measure a patient's self-perceived impact of dizziness on their daily life, divided into physical, emotional, and functional subscales. In this study, only the total score (sum of subscales) was used. To score the DHI, each of the 25 questions is answered with "Yes" (4 points), "Sometimes" (2 points), or "No" (0 points), resulting in a total score from 0 to 100. A higher score indicates a greater perceived handicap, a lower score indicates less perceived handicap. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
TERMINATED
NA
28 participants
This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
2025-12-17
Participant Flow
31 healthy controls were approached, and 28 healthy controls were enrolled in and completed the study. Three potential participants were excluded due to not meet the entry criterion of sufficient convergence (as determined by the oculomotor screening). No subjects were approached or recruited into the usual vestibular rehabilitation care, nor the home exercises using virtual reality device arms, due to the departure of study personnel able to recruit the stated populations.
Participant milestones
| Measure |
Healthy Control
Age-matched healthy control subjects will perform all balance, gait, vestibular, and patient reported outcome measure assessments, including performing 30 seconds of each level of gaze stability exercise for an active comparison to outcomes obtained to those with vestibular disorders. Healthy control participants will only be assessed at baseline (a single visit).
|
Usual Vestibular Rehabilitation Care
Participants in this arm will perform typical PT in the clinic and home environment. They will be asked to keep a log to track their HEP.
|
Home Exercises Using Virtual Reality Device
Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
0
|
0
|
|
Overall Study
COMPLETED
|
28
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Control
n=28 Participants
Age-matched healthy control subjects will perform all balance, gait, vestibular, and patient reported outcome measure assessments, including performing 30 seconds of each level of gaze stability exercise for an active comparison to outcomes obtained to those with vestibular disorders.
|
Usual Vestibular Rehabilitation Care
Participants in this arm will perform typical PT in the clinic and home environment. They will be asked to keep a log to track their HEP.
|
Home Exercises Using Virtual Reality Device
Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23 Years
n=28 Participants
|
—
|
—
|
23 Years
n=28 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=28 Participants
|
0 Participants
|
0 Participants
|
20 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=28 Participants
|
0 Participants
|
0 Participants
|
8 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Dizziness Handicap Inventory
|
29 unit on a scale
n=28 Participants
|
—
|
—
|
29 unit on a scale
n=28 Participants
|
|
Head Impulse Test
|
0 Participants
n=28 Participants
|
—
|
—
|
0 Participants
n=28 Participants
|
|
Visual Vertigo Analogue Scale
|
0.23 units on a scale
n=28 Participants
|
—
|
—
|
0.23 units on a scale
n=28 Participants
|
|
Functional Gait Assessment
|
29 Units on a scale
n=28 Participants
|
—
|
—
|
29 Units on a scale
n=28 Participants
|
|
Modified Clinical Test of Sensory Integration and Balance (mCTSIB)
|
120 units on a scale
n=28 Participants
|
—
|
—
|
120 units on a scale
n=28 Participants
|
PRIMARY outcome
Timeframe: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.Population: Only healthy controls were enrolled in this study due to early termination.
Final score on the Dizziness Handicap Inventory. The Dizziness Handicap Inventory (DHI) is a 25-item questionnaire used to measure a patient's self-perceived impact of dizziness on their daily life, divided into physical, emotional, and functional subscales. In this study, only the total score (sum of subscales) was used. To score the DHI, each of the 25 questions is answered with "Yes" (4 points), "Sometimes" (2 points), or "No" (0 points), resulting in a total score from 0 to 100. A higher score indicates a greater perceived handicap, a lower score indicates less perceived handicap. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Outcome measures
| Measure |
Usual Vestibular Rehabilitation Care
Participants in this arm will perform typical PT in the clinic and home environment. They will be asked to keep a log to track their HEP.
|
Home Exercises Using Virtual Reality Device
Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.
|
Healthy Control
n=28 Participants
Age-matched healthy control subjects will perform all balance, gait, vestibular, and patient reported outcome measure assessments, including performing 30 seconds of each level of gaze stability exercise for an active comparison to outcomes obtained to those with vestibular disorders.
|
|---|---|---|---|
|
Dizziness Handicap Inventory
|
—
|
—
|
29 units on a scale
Interval 28.0 to 30.0
|
PRIMARY outcome
Timeframe: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.Population: No positive findings in head impulse test was determined due to healthy control individuals only attending one session. Only healthy controls were enrolled in this study due to early study termination.
Assessment of VOR-evoked gaze stability. The head impulse test (HIT) assesses the vestibulo-ocular reflex (VOR) to detect peripheral vestibular dysfunction, or a weakened balance system in the inner ear. In the test, the examiner quickly rotates a patient's head while the patient tries to keep their eyes fixed on a target. A normal response involves the eyes staying fixed on the target, but an abnormal test shows the eyes moving away with the head and then quickly "catching up" with a corrective saccade, indicating the VOR isn't keeping up. Count of participants enrolled in the study are those with a positive clinical finding. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Outcome measures
| Measure |
Usual Vestibular Rehabilitation Care
Participants in this arm will perform typical PT in the clinic and home environment. They will be asked to keep a log to track their HEP.
|
Home Exercises Using Virtual Reality Device
Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.
|
Healthy Control
n=28 Participants
Age-matched healthy control subjects will perform all balance, gait, vestibular, and patient reported outcome measure assessments, including performing 30 seconds of each level of gaze stability exercise for an active comparison to outcomes obtained to those with vestibular disorders.
|
|---|---|---|---|
|
Head Impulse Test at Final Assessment
|
—
|
—
|
0 Participants with positive findings.
|
SECONDARY outcome
Timeframe: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.Population: Only healthy control participants were enrolled due to early termination of this study.
Final assessment. The Visual Vertigo Analogue Scale (VVAS) is a 9-item self-administered questionnaire that assesses the intensity of visual vertigo in various challenging visual situations. Patients mark a 10-cm line for each of the nine items to indicate dizziness severity (0 indicates no dizziness and 10 as extreme). Scores are averaged and then multiplied by 10 for a scale from 0 to 100, where a lower score indicates a milder symptom level, and higher score indicates more severe symptoms of visual vertigo. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Outcome measures
| Measure |
Usual Vestibular Rehabilitation Care
n=28 Participants
Participants in this arm will perform typical PT in the clinic and home environment. They will be asked to keep a log to track their HEP.
|
Home Exercises Using Virtual Reality Device
Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.
|
Healthy Control
Age-matched healthy control subjects will perform all balance, gait, vestibular, and patient reported outcome measure assessments, including performing 30 seconds of each level of gaze stability exercise for an active comparison to outcomes obtained to those with vestibular disorders.
|
|---|---|---|---|
|
Visual Vertigo Analogue Scale Final Assessment
|
0.23 units on a scale
Interval 0.0 to 3.0
|
—
|
—
|
SECONDARY outcome
Timeframe: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.Population: Only healthy control participants were enrolled in this study due to early termination.
The Functional Gait Assessment (FGA) is a 10-item clinical test used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. Each of the 10 items is scored on a 0-3 scale (0=severe impairment, 3=normal), with the total score ranging from 0 to 30 indicating balance and gait ability. A higher FGA score signifies better performance, and a lower score indicates poorer performance. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Outcome measures
| Measure |
Usual Vestibular Rehabilitation Care
n=28 Participants
Participants in this arm will perform typical PT in the clinic and home environment. They will be asked to keep a log to track their HEP.
|
Home Exercises Using Virtual Reality Device
Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.
|
Healthy Control
Age-matched healthy control subjects will perform all balance, gait, vestibular, and patient reported outcome measure assessments, including performing 30 seconds of each level of gaze stability exercise for an active comparison to outcomes obtained to those with vestibular disorders.
|
|---|---|---|---|
|
Functional Gait Assessment Final Assessment
|
29 units on a scale
Interval 28.0 to 30.0
|
—
|
—
|
SECONDARY outcome
Timeframe: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.Population: Only healthy control participants were recruited due to early study termination.
The Modified Clinical Test of Sensory Integration and Balance (mCTSIB) is a four-condition balance assessment that evaluates how well individuals use their visual, somatosensory, and vestibular systems to maintain balance. The scoring involves timing up to three trials of each of the four conditions for 30 seconds, and then summing the average of trials within each condition. The total score ranges from 0 to 120, where a lower score indicates poorer performance and a higher score indicates better performance. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Outcome measures
| Measure |
Usual Vestibular Rehabilitation Care
n=28 Participants
Participants in this arm will perform typical PT in the clinic and home environment. They will be asked to keep a log to track their HEP.
|
Home Exercises Using Virtual Reality Device
Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.
|
Healthy Control
Age-matched healthy control subjects will perform all balance, gait, vestibular, and patient reported outcome measure assessments, including performing 30 seconds of each level of gaze stability exercise for an active comparison to outcomes obtained to those with vestibular disorders.
|
|---|---|---|---|
|
Modified Clinical Test of Sensory Integration and Balance (mCTSIB) Final Performance
|
120 units on a scale
Interval 120.0 to 120.0
|
—
|
—
|
Adverse Events
Healthy Control
Usual Vestibular Rehabilitation Care
Home Exercises Using Virtual Reality Device
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