Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit

April 7, 2025 updated by: Eytan A. David

Randomized Controlled Trial of Computerized Dynamic Posturography-assisted Vestibular Retraining Compared With At-home Vestibular Rehabilitation Exercises for Stable Unilateral Vestibular Deficit

People that have difficulty with balance have a higher risk of falling and reduced quality of life. Some individuals can learn to compensate using their vision, their sense of where their limbs are in space, and balance organs that are still intact. Rehabilitation exercises, which typically involve shaking and nodding of the head, are often prescribed for dizzy patients but are not effective for everyone. Our study aims to determine if specific exercises performed on footplate sensors with visual feedback is superior to traditional rehabilitation exercises done at home for improving balance and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7M 2H5
        • Dr. EA David MD FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Dizziness handicap inventory score at time of enrolment over 30

  • Unilateral vestibular weakness confirmed one or more of:

    • Videonystagmography showing unilateral weakness to bithermal testing of greater than 25%
    • VEMP: IAD asymmetry of greater than 40% for both cVEMP and oVEMP
    • VEMP: absence of both ocular and cervical vemp responses in one ear in the context of normal and replicable other ear
    • 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 six months

Exclusion Criteria:

  • 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 dehiscence (SDCS)
  • Active benign paroxysmal positional vertigo (BPPV)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vestibular retraining with dynamic posturography
12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
Device: Vestibular retraining with dynamic posturography
12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
Active Comparator: At-home rehabilitation exercises
Daily rehabilitation exercises involving nodding and shaking of the head
Behavioral: At-home rehabilitation exercises
6 weeks of daily rehabilitation exercises involving nodding and shaking of the head

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SOT composite score
Time Frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function)
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Dizziness Handicap Inventory
Time Frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Dizziness Handicap Inventory (DHI); 16-30 Points (mild handicap), 32-52 Points (moderate handicap), 54+ Points (severe handicap)
Through study completion, 12 rehabilitation sessions, an average of 7 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ABC Score
Time Frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Activity-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate better function)
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
FES-I score
Time Frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater impairment
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
SOT condition scores
Time Frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in mean SOT scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function)
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
LOS directional control
Time Frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
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
LOS excursion
Time Frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
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
DHI component scores
Time Frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Emotional, physical, and functional components of the DHI score
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
SOT vestibular contribution
Time Frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Change in mean value of SOT 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eytan A. David

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eytan A David, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H21-03343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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