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DizzinessNCT04875013

Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

A study testing Vestibular rehabilitation with dynamic posturography in people with Dizziness and Equilibrium; Disorder, Labyrinth, run by Eytan A. David at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Vestibular rehabilitation with dynamic posturography
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteCanada
Study dates
10 May 2021to 31 Oct 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult Age 18-80
  • Unilateral vestibular weakness confirmed one or more of:
  • Videonystagmography
  • VEMP
  • 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

Who cannot join

  • Orthopedic deficit (eg. lower body joint dysfunction or lower joint replacement)
  • Neurological deficit or proprioception deficit
  • Diabetes
  • Poor vision or blindness
  • Fluctuating vestibular symptoms, or condition known to fluctuate eg. Menière's disease, perilymphatic fistula (PLF) or superior canal deshicsence (SDCS)
  • Active benign paroxysmal positional vertigo (BPPV)
Show all 9Show fewer
  • Undergoing treatment which may affect balance or ability to stand
  • Cognitive impairment that prevents understanding and responding to instructions required to complete the study
  • Inability to provide informed consent

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Dr. EA David MD FRCSC

    North Vancouver, British Columbia, V7M 2H5

Other trials in Canada

About this study

Official title: Efficacy of Vestibular Rehabilitation Using Computerized Dynamic Posturography With Virtual Reality for Stable Unilateral Vestibular Weakness

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.

Being tested
Vestibular rehabilitation with dynamic posturography
Medical subject headings
Dizziness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vestibular rehabilitation with dynamic posturographyDevice

    Rehabilitation exercises guided by an interactive display and measured by a footplate sensor

Study groups in NCT04875013
Study groupRoleWhat they receive
Vestibular rehabilitation with dynamic posturographyExperimental12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
Receives: Device: Vestibular rehabilitation with dynamic posturography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

  2. 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)

    Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

  3. 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)

    Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

  4. 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

    Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

  5. 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)

    Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

Secondary outcomes (4)

  1. 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

    Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

  2. 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

    Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

  3. 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)

    Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

  4. 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)

    Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start10 May 2021
  3. Primary completion31 Oct 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Longitudinal cohort; single group assignment; interventional
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875013
Sponsor's protocol ID
H20-04045
Status last verified
Nov 2022
First submitted
27 Apr 2021
Last updated
20 Dec 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No individual participant data will be shared.

Publications

  • 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.

    PubMed 40217271

  • 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.

    PubMed 40072844

  • 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.

    PubMed 37173291

  • 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.

    PubMed 35357406

Questions about this trial

What is this clinical trial studying?

A study testing Vestibular rehabilitation with dynamic posturography in people with Dizziness and Equilibrium; Disorder, Labyrinth, run by Eytan A. David at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline) (time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04875013, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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