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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vestibular rehabilitation with dynamic posturography | Experimental | 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vestibular rehabilitation with dynamic posturography | Device | Rehabilitation exercises guided by an interactive display and measured by a footplate sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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) | 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) | 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 | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
| Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Rehabilitation Protocol | Percentage of subjects that complete 12 sessions | Through study completion, maximum of 12 weeks |
| Missed Sessions | Mean number of missed and rescheduled rehabilitation sessions |
Inclusion Criteria:
Adult Age 18-80
Unilateral vestibular weakness confirmed one or more of:
Or unilateral vestibular weakness idiopathic, not yet diagnosed (NYD)
Persistent imbalance following diagnosis of resolved benign paroxysmal positional vertigo (BPPV)
Symptomatic
Long-standing/persistent symptoms greater than one year
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eytan David, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. EA David MD FRCSC | North Vancouver | British Columbia | V7M 2H5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40217271 | Derived | David EA, Shahnaz N. Posturographic sensory ratios provide evidence for neuroplasticity after computerized vestibular rehabilitation therapy in a single group interventional trial. J Neuroeng Rehabil. 2025 Apr 11;22(1):81. doi: 10.1186/s12984-025-01608-w. | |
| 40072844 | Derived | David EA, Shahnaz N, Wiseman I, David Y, Cochrane CL. Computerized Dynamic Posturography-Guided Vestibular Rehabilitation Improves Vestibular Sensory Ratios. Ear Nose Throat J. 2025 Mar 12:1455613251321978. doi: 10.1177/01455613251321978. Online ahead of print. |
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No individual participant data will be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vestibular Rehabilitation With Dynamic Posturography | 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vestibular Rehabilitation With Dynamic Posturography | 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Median | 95% Confidence Interval | SOT composite score | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
|
Duration of the treatment period until the post-treatment follow up (approximately 7 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vestibular Rehabilitation With Dynamic Posturography | 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eytan David | DR. EYTAN A. DAVID, MD, Otolaryngologist | (604) 988-0598 | dr.david@shaw.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2021 | Oct 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Longitudinal cohort; single group assignment; interventional
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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) |
| Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
| 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 | 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) | 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) | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
| Through study completion, maximum of 12 weeks |
| 37173291 | Derived | David EA, Shahnaz N. Dynamic posturography after computerized vestibular retraining for stable unilateral vestibular deficits. Acta Otolaryngol. 2023 May;143(5):396-401. doi: 10.1080/00016489.2023.2208615. Epub 2023 May 12. |
| 35357406 | Derived | David EA, Shahnaz N. Patient-Reported Disability After Computerized Posturographic Vestibular Retraining for Stable Unilateral Vestibular Deficit. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):426-433. doi: 10.1001/jamaoto.2022.0167. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | 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) | Posted | Median | 95% Confidence Interval | score on a scale | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
|
|
|
| Primary | 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) | Posted | Median | 95% Confidence Interval | score on a scale | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
|
|
|
| Primary | 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 | Posted | Median | 95% Confidence Interval | score on a scale | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
|
|
|
| Primary | 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) | Posted | Median | 95% Confidence Interval | units on a scale | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
|
|
|
| Secondary | 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:
| Posted | Median | 95% Confidence Interval | score on a scale | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
|
|
|
| Secondary | 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 | Posted | Median | 95% Confidence Interval | ratio of scores on a scale | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
|
|
|
| Secondary | 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) | Posted | Median | 95% Confidence Interval | Directional control % | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
|
|
|
| Secondary | 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) | Posted | Median | 95% Confidence Interval | excursion as % of limit of stability | Through study completion, 12 rehabilitation sessions, an average of 7 weeks |
|
|
|
| Other Pre-specified | Adherence to Rehabilitation Protocol | Percentage of subjects that complete 12 sessions | Posted | Count of Participants | Participants | Through study completion, maximum of 12 weeks |
|
|
|
| Other Pre-specified | Missed Sessions | Mean number of missed and rescheduled rehabilitation sessions | Posted | Mean | Full Range | number is missed sessions / participant | Through study completion, maximum of 12 weeks |
|
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| Title | Measurements |
|---|---|
|
| SOT condition 4 |
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| SOT condition 5 |
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| SOT condition 6 |
|