DizzinessNCT05115032
Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit
A study testing Vestibular retraining with dynamic posturography and At-home rehabilitation exercises in people with Dizziness and Equilibrium; Disorder, Labyrinth, run by Eytan A. David at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dizziness, Equilibrium; Disorder, Labyrinth, Inner Ear Injury
- What is being tested?
- Vestibular retraining with dynamic posturography and At-home rehabilitation exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2022to 19 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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)
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- Persistent imbalance following diagnosis of resolved benign paroxysmal positional vertigo (BPPV)
- Symptomatic
- Long-standing/persistent symptoms greater than six months
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 dehiscence (SDCS)
- Active benign paroxysmal positional vertigo (BPPV)
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- 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.
About this study
Official title: 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.
- Being tested
- Vestibular retraining with dynamic posturography, At-home rehabilitation exercises
- Medical subject headings
- Dizziness, Labyrinth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular retraining with dynamic posturographyDevice
12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
At-home rehabilitation exercisesBehavioural
6 weeks of daily rehabilitation exercises involving nodding and shaking of the head
| Study group | Role | What they receive |
|---|---|---|
| Vestibular retraining with dynamic posturography | Experimental | 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Receives: Device: Vestibular retraining with dynamic posturography |
| At-home rehabilitation exercises | Active comparator | Daily rehabilitation exercises involving nodding and shaking of the head Receives: Behavioral: At-home rehabilitation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOT composite score
Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function)
Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Dizziness Handicap Inventory
Change in Dizziness Handicap Inventory (DHI); 16-30 Points (mild handicap), 32-52 Points (moderate handicap), 54+ Points (severe handicap)
Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary outcomes (7)
ABC Score
Change in Activity-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate better function)
Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
FES-I score
Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater impairment
Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
SOT condition scores
Change in mean SOT scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function)
Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
LOS directional control
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
LOS excursion
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
DHI component scores
Emotional, physical, and functional components of the DHI score
Measured: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
SOT vestibular contribution
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
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.
- First posted10 Nov 2021
- Study start17 Jan 2022
- Primary completion15 Dec 2022
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled interventional trial; single crossover; single-centre, open label
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eytan A. David
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eytan A. David, University of British Columbia
- Investigators
- Eytan A David, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115032
- Sponsor's protocol ID
- H21-03343
- Status last verified
- May 2024
- First submitted
- 29 Oct 2021
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
David EA, Shahnaz N, Wiseman I, David Y, Cochrane CL. Vestibular Rehabilitation Using Dynamic Posturography: Functional Stability and Fall Risk Outcomes From a Randomized Trial. Otolaryngol Head Neck Surg. 2025 Sep;173(3):713-723. doi: 10.1002/ohn.1302. Epub 2025 Jul 7.
PubMed 40624853
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Computerized Dynamic Posturography-assisted Vestibular Retraining Compared With At-home Vestibular Rehabilitation Exercises for Stable Unilateral Vestibular Deficit
- ClinicalTrials.gov ID
- NCT05115032
- Acronym / sponsor ID
- H21-03343
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Eytan A. DavidUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled interventional trial; single crossover; single-centre, open label
| Arm | Type | Receives |
|---|---|---|
| Vestibular retraining with dynamic posturography | Experimental | Device: Vestibular retraining with dynamic posturography12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback |
| At-home rehabilitation exercises | Active comparator | Behavioral: At-home rehabilitation exercisesDaily rehabilitation exercises involving nodding and shaking of the head |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Dizziness handicap inventory score at time of enrolment over 30
- Unilateral vestibular weakness confirmed one or more of:
- Persistent imbalance following diagnosis of resolved benign paroxysmal positional vertigo (BPPV)
- Symptomatic
- Long-standing/persistent symptoms greater than six months
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular retraining with dynamic posturography12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback | Device | Vestibular retraining with dynamic posturography |
| At-home rehabilitation exercises6 weeks of daily rehabilitation exercises involving nodding and shaking of the head | Behavioural | At-home rehabilitation exercises |
Primary outcome
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)
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)
7 secondary outcomes
ABC Score
Time frame: 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
SOT condition scores
Time frame: 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
LOS excursion
Time frame: 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
SOT vestibular contribution
Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 40624853David EA, Shahnaz N, Wiseman I, David Y, Cochrane CL. Vestibular Rehabilitation Using Dynamic Posturography: Functional Stability and Fall Risk Outcomes From a Randomized Trial. Otolaryngol Head Neck Surg. 2025 Sep;173(3):713-723. doi: 10.1002/ohn.1302. Epub 2025 Jul 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eytan A David, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular retraining with dynamic posturography and At-home rehabilitation exercises 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 9 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 10 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SOT composite score (time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks). The study lists 2 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 NCT05115032, which also lists 1 linked publication.
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 10 Apr 2025.