An interventional study of Vestibular rehabilitation with dynamic posturography in Dizziness, Equilibrium; Disorder, Labyrinth and Inner Ear Injury, sponsored by Eytan A. David. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Eytan A. David · Not applicable, Interventional, and Treatment
People that have difficulty with balance, such as those with damage to their inner ear, have a higher risk of falling, which may lead to anxiety and reduced quality of life. Some individuals that have lost part of their sense of balance can learn to compensate using information from their vision, their sense of where their limbs are in space, and from other balance organs that are still intact. Our study aims to determine if virtual reality used together with information from footplate sensors can be used to train people with balance problems to compensate for their inner ear deficits.
226 studies on the registry are indexed under Dizziness; 56 are open to participants now.
This study's enrollment of 13 is below the median of 43 across 170 interventional studies indexed under Dizziness.
Browse Dizziness studies →Eytan A. David is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Unilateral vestibular weakness confirmed one or more of:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
Device: Vestibular rehabilitation with dynamic posturography
Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)
Change in composite score of Sensory Organization Test (SOT) (Scores from 0-100; higher scores indicate better function); Lower scores indicate larger amount of sway Calculated as a composite of the 6 individual conditions of the SOT: 1. Eyes open on firm surface 2. Eyes closed on firm surface 3. Eyes open with sway referenced visual 4. Eyes open on sway referenced support surface 5. Eyes close on sway referenced support surfrace 6. Eyes open on sway referenced support surface and visual
Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline)
Change in Dizziness Handicap Inventory (DHI); scale from 0-100; higher scores indicate greater disability; 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap)
Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)
Change in Activities-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate greater confidence in performing activities of daily living)
Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline)
Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater perceived fall risk
Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline)
Change in endpoint excursion and maximum excursion functional stability region area, calculated from Limits of Stability (LOS) score Higher score indicates an ability to volitionally lean to larger angles. 100% of theoretical maximum in all directions would give an area of 28284. LOS excursion scores were calculated by the instrument software, from which we calculated the area of the endpoint excursion functional stability region (the sum of areas between adjacent Endpoint Excursion limits) and the area of the maximum excursion functional stability region (the sum of areas between adjacent Maximum Excursion limits) using published methods (Alvarez-Otero R, Perez-Fernandez N. The limits of stability in patients with unilateral vestibulopathy. Acta Oto-laryngol. 2017;137(10):1-6. doi:10.1080/00016489.2017.1339326)
Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline)
Change in mean Sensory Organization Test Scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function) The 6 conditions are: 1. Eyes open on firm surface 2. Eyes closed on firm surface 3. Eyes open with sway referenced visual 4. Eyes open on sway referenced support surface 5. Eyes close on sway referenced support surfrace 6. Eyes open on sway referenced support surface and visual
Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)
Change in mean value of Sensory Organization Test condition 5/mean value of SOT conditions 1; measured as a ratio, higher scores indicate a greater vestibular contribution to balance deficit
Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)
Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function)
Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline)
Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function)
Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Adherence to Rehabilitation Protocol
Percentage of subjects that complete 12 sessions
Time frame: Through study completion, maximum of 12 weeks
Missed Sessions
Mean number of missed and rescheduled rehabilitation sessions
Time frame: Through study completion, maximum of 12 weeks
| Milestone | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Started | 13 |
| Post-treatment assessment | 13 |
| Completed | 9 |
| Not completed | 4 |
Change in composite score of Sensory Organization Test (SOT) (Scores from 0-100; higher scores indicate better function); Lower scores indicate larger amount of sway Calculated as a composite of the 6 individual conditions of the SOT: 1. Eyes open on firm surface 2. Eyes closed on firm surface 3. Eyes open with sway referenced visual 4. Eyes open on sway referenced support surface 5. Eyes close on sway referenced support surfrace 6. Eyes open on sway referenced support surface and visual
| SOT composite score | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline) | 8.8 (0.6 to 19.1) |
Change in Dizziness Handicap Inventory (DHI); scale from 0-100; higher scores indicate greater disability; 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap)
| score on a scale | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline) | -16 (-20 to 2) |
Change in Activities-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate greater confidence in performing activities of daily living)
| score on a scale | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline) | 11.87 (0 to 17.30) |
Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater perceived fall risk
| score on a scale | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline) | -9 (-14 to 1) |
Change in endpoint excursion and maximum excursion functional stability region area, calculated from Limits of Stability (LOS) score Higher score indicates an ability to volitionally lean to larger angles. 100% of theoretical maximum in all directions would give an area of 28284. LOS excursion scores were calculated by the instrument software, from which we calculated the area of the endpoint excursion functional stability region (the sum of areas between adjacent Endpoint Excursion limits) and the area of the maximum excursion functional stability region (the sum of areas between adjacent Maximum Excursion limits) using published methods (Alvarez-Otero R, Perez-Fernandez N. The limits of stability in patients with unilateral vestibulopathy. Acta Oto-laryngol. 2017;137(10):1-6. doi:10.1080/00016489.2017.1339326)
| units on a scale | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Endpoint excursion functional stability region | 6226 (24 to 14547) |
| Maximum excursion functional stability region | 9802 (2248 to 21168) |
Change in mean Sensory Organization Test Scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function) The 6 conditions are: 1. Eyes open on firm surface 2. Eyes closed on firm surface 3. Eyes open with sway referenced visual 4. Eyes open on sway referenced support surface 5. Eyes close on sway referenced support surfrace 6. Eyes open on sway referenced support surface and visual
| score on a scale | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| SOT condition 1 | 0.6 (-1.5 to 4.3) |
| SOT condition 2 | -1.8 (-4.2 to 2.0) |
| SOT condition 3 | -1.6 (-3.2 to 2.6) |
| SOT condition 4 | 13.9 (3.0 to 27.8) |
| SOT condition 5 | 11.1 (1.6 to 23.4) |
| SOT condition 6 | 13.1 (2.9 to 34.4) |
Change in mean value of Sensory Organization Test condition 5/mean value of SOT conditions 1; measured as a ratio, higher scores indicate a greater vestibular contribution to balance deficit
| ratio of scores on a scale | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline) | 0.10 (-0.06 to 0.25) |
Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function)
| Directional control % | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline) | 41.1 (5.9 to 79) |
Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function)
| excursion as % of limit of stability | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Endpoint excursion | 36 (2 to 51) |
| Maximum excursion | 47 (5.9 to 79) |
Percentage of subjects that complete 12 sessions
| Participants | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Adherence to Rehabilitation Protocol | 13 |
Mean number of missed and rescheduled rehabilitation sessions
| number is missed sessions / participant | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Missed Sessions | 0 (0 to 0) |
Collected over Duration of the treatment period until the post-treatment follow up (approximately 7 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vestibular Rehabilitation With Dynamic Posturography | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Median | 51 (18 to 67) |
| Sex: Female, Male(Participants) | Vestibular Rehabilitation With Dynamic Posturography |
|---|---|
| Female | 5 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | Vestibular Rehabilitation With Dynamic Posturography |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No individual participant data will be shared.
Ran from May 2021 to primary completion in Oct 2021, 5 months.
Results were first posted in Dec 2022, 1 year 1 month after primary completion.
Of 82 non-industry interventional studies with no phase under Dizziness, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's 5 months is below that.
Counting every sponsor, half of 90 studies reached it within 20 months; a quarter within 8 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Eytan A. David