Vestibular DisorderVR-HS-WSTNCT05942781
Concurrent Vestibular Activation and Postural Training Using Virtual Reality
A study of Vestibular Disorder, run by Clarkson University at 1 site in United States.
Trial summary
Postural instability is a common symptom of vestibular dysfunction that impacts a person's day-to-day activities. Vestibular rehabilitation is effective in decreasing dizziness, visual symptoms and improving postural control through several mechanisms including sensory reweighting. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to stand independently (without an assistive device)
- This study requires participants to perform postural assessments including reactive balance following mechanical perturbations.
- Participants will also perform headshake activities and weight shift training in standing for 20 mins will mini breaks.
- Participants must be between the ages of 55-80.
Who cannot join
- Participants with evidence of:
- Concussion, vestibular, balance or oculomotor issues for the prior 6 months.
- Neuropathic conditions, particularly affecting the lower extremities. Participants with this issue will have sensory impairments which can affect their sensory assessment.
- Current musculoskeletal deficits including significant postural abnormalities (signs of spinal, pelvic and leg length discrepancies).
- Pain or limitations in neck range of motion.
- Recent (within 6 months) orthopedic surgery that impacts postural training.
- Visual Impairment ○ Participants must be able to see and follow targets in the virtual reality environment. Therefore, subjects must have 20/50 (corrected) vision. Subjects who are blind cannot participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Concurrent Vestibular Activation and Postural Training on Postural Control Using Virtual Reality
Postural instability is a common symptom of vestibular dysfunction that impacts a person's day-to-day activities. Vestibular rehabilitation is effective in decreasing dizziness, visual symptoms and improving postural control through several mechanisms including sensory reweighting. As part of the sensory reweighting mechanisms, vestibular activation training with headshake activities influence vestibular reflexes. However, combining challenging vestibular and postural tasks to facilitate more effective rehabilitation outcomes is under-utilized. The novel concurrent headshake and weight shift training (Concurrent HS-WST) is purported to train the vestibular system to directly impact the postural control system simultaneously and engage sensory reweighting to improve balance. Healthy older adults will perform the training by donning a virtual reality headset and standing on the floor or foam pad with an overhead harness on and a spotter present to prevent any falls. The investigators propose that this training strategy would show improved outcomes over traditional training methods by improving vestibular-ocular reflex (VOR) gains, eye movement variability, sensory reweighting and promoting postural balance. The findings of this study may guide clinicians to develop rehabilitation methods for vestibular postural control in neurological populations with vestibular and/or sensorimotor control impairment.
- Conditions
- Vestibular Disorder
- Being tested
- Vestibular training using VR followed by Control, Control followed by Vestibular training using VR
- Keywords
- sensory reweighting, vestibular rehabilitation, vestibular reflex, virtual reality
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular training using VR followed by ControlDevice
A cross-over design will be used with group one receiving the training intervention for 7 days, a 6-day washout period, and a 7-day no-training period.
Control followed by Vestibular training using VRDevice
Group two will follow the reverse sequence.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular activation training | Experimental | A cross-over design will be used with group one receiving the training intervention for 7 days, a 6-day washout period, and a 7-day no-training period. Group two will follow the reverse sequence. Receives: Device: Vestibular training using VR followed by Control; Device: Control followed by Vestibular training using VR |
| No training | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibulo-ocular reflex (VOR) gain
Horizontal and vertical vestibulo-ocular reflex (VOR) gain will be assessed using the video head impulse test (vHIT; ICS, Otometrics, Taastrup, Denmark). Twenty head impulses each will be performed to assess each direction of the semicircular canals with participant in a seated position.
Measured: Three week study period
Eye movement variability
Horizontal and vertical eye movements will be assessed during force plate perturbation trials using BlueGain electro-oculography (EOG) device (Cambridge Research Systems). Participants will stand on a force plate perturbation device with EOG electrodes affixed on eye muscles to record eye movements during toes up (simulating being pushed backward) and toes down (simulating being pushed forward) perturbation rotation trials.
Measured: Three week study period
Electromyography (EMG) amplitude
Electromyography (EMG) will be assessed during force plate perturbation trials using Delsys Trigno wireless sensors (Delsys Inc., Boston, MA). Participants will stand on a force plate perturbation device with EMG sensors placed on postural muscles to record electrical activity during toes up (simulating being pushed backward) and toes down (simulating being pushed forward) perturbation rotation trials.
Measured: Three week study period
Electromyography (EMG) time onset
Electromyography (EMG) will be assessed during force plate perturbation trials using Delsys Trigno wireless sensors (Delsys Inc., Boston, MA). Participants will stand on a force plate perturbation device with EMG sensors placed on postural muscles to record electrical activity during toes up (simulating being pushed backward) and toes down (simulating being pushed forward) perturbation rotation trials.
Measured: Three week study period
Balance equilibrium and composite scores
Equilibrium and composite scores will be assessed by the Modified Clinical Test for Sensory Interaction on Balance (MCTSIB; NeuroCom®, Natus Medical Inc., Pleasanton, CA) during quiet stance. The MCTSIB requires the participant to stand upright as stable as possible for 10 s under four different conditions: (1) eyes open (EO) on a stable surface (SS), (2) eyes closed (EC) on SS, (3) EO on foam surface (FS), (4) EC on FS.
Measured: Three week study period
Sensory ratios
Sensory ratios will be assessed by the Modified Clinical Test for Sensory Interaction on Balance (MCTSIB; NeuroCom®, Natus Medical Inc., Pleasanton, CA) during quiet stance. The MCTSIB requires the participant to stand upright as stable as possible for 10 s under four different conditions: (1) eyes open (EO) on a stable surface (SS), (2) eyes closed (EC) on SS, (3) EO on foam surface (FS), (4) EC on FS.
Measured: Three week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start15 Apr 2024
- Primary completion30 Dec 2024
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisorderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarkson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwadwo Appiah-Kubi, Clarkson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942781
- Sponsor's protocol ID
- 23-30
- Acronym
- VR-HS-WST
- Status last verified
- Jun 2025
- First submitted
- 23 Mar 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concurrent Vestibular Activation and Postural Training on Postural Control Using Virtual Reality
- ClinicalTrials.gov ID
- NCT05942781
- Acronym / sponsor ID
- VR-HS-WST / 23-30
- Conditions
- Vestibular Disorder
- Keywords
- sensory reweighting, vestibular rehabilitation, vestibular reflex, virtual reality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Clarkson UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 12 Jul 2023 (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.
Postural instability is a common symptom of vestibular dysfunction that impacts a person's day-to-day activities. Vestibular rehabilitation is effective in decreasing dizziness, visual symptoms and improving postural control through several mechanisms including sensory reweighting. As part of the sensory reweighting mechanisms, vestibular activation training with headshake activities influence vestibular reflexes. However, combining challenging vestibular and postural tasks to facilitate more effective rehabilitation outcomes is under-utilized. The novel concurrent headshake and weight shift training (Concurrent HS-WST) is purported to train the vestibular system to directly impact the postural control system simultaneously and engage sensory reweighting to improve balance. Healthy older adults will perform the training by donning a virtual reality headset and standing on the floor or foam pad with an overhead harness on and a spotter present to prevent any falls. The investigators propose that this training strategy would show improved outcomes over traditional training methods by improving vestibular-ocular reflex (VOR) gains, eye movement variability, sensory reweighting and promoting postural balance. The findings of this study may guide clinicians to develop rehabilitation methods for vestibular postural control in neurological populations with vestibular and/or sensorimotor control impairment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular activation training | Experimental | Device: Vestibular training using VR followed by Control, Device: Control followed by Vestibular training using VRA cross-over design will be used with group one receiving the training intervention for 7 days, a 6-day washout period, and a 7-day no-training period. Group two will follow the reverse sequence. |
| No training | No intervention | – |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to stand independently (without an assistive device)
- Participants must be between the ages of 55-80.
Key exclusion criteria (7 listed)
- Participants with evidence of:
- Recent (within 6 months) orthopedic surgery that impacts postural training.
- Visual Impairment ○ Participants must be able to see and follow targets in the virtual reality environment. Therefore, subjects must have 20/50 (corrected) vision. Subjects who are blind cannot participate.
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 training using VR followed by ControlA cross-over design will be used with group one receiving the training intervention for 7 days, a 6-day washout period, and a 7-day no-training period. | Device | Vestibular activation training |
| Control followed by Vestibular training using VRGroup two will follow the reverse sequence. | Device | Vestibular activation training |
Primary outcome
Vestibulo-ocular reflex (VOR) gain
Time frame: Three week study period
Horizontal and vertical vestibulo-ocular reflex (VOR) gain will be assessed using the video head impulse test (vHIT; ICS, Otometrics, Taastrup, Denmark). Twenty head impulses each will be performed to assess each direction of the semicircular canals with participant in a seated position.
Eye movement variability
Time frame: Three week study period
Horizontal and vertical eye movements will be assessed during force plate perturbation trials using BlueGain electro-oculography (EOG) device (Cambridge Research Systems). Participants will stand on a force plate perturbation device with EOG electrodes affixed on eye muscles to record eye movements during toes up (simulating being pushed backward) and toes down (simulating being pushed forward) perturbation rotation trials.
Electromyography (EMG) amplitude
Time frame: Three week study period
Electromyography (EMG) will be assessed during force plate perturbation trials using Delsys Trigno wireless sensors (Delsys Inc., Boston, MA). Participants will stand on a force plate perturbation device with EMG sensors placed on postural muscles to record electrical activity during toes up (simulating being pushed backward) and toes down (simulating being pushed forward) perturbation rotation trials.
Electromyography (EMG) time onset
Time frame: Three week study period
Electromyography (EMG) will be assessed during force plate perturbation trials using Delsys Trigno wireless sensors (Delsys Inc., Boston, MA). Participants will stand on a force plate perturbation device with EMG sensors placed on postural muscles to record electrical activity during toes up (simulating being pushed backward) and toes down (simulating being pushed forward) perturbation rotation trials.
Balance equilibrium and composite scores
Time frame: Three week study period
Equilibrium and composite scores will be assessed by the Modified Clinical Test for Sensory Interaction on Balance (MCTSIB; NeuroCom®, Natus Medical Inc., Pleasanton, CA) during quiet stance. The MCTSIB requires the participant to stand upright as stable as possible for 10 s under four different conditions: (1) eyes open (EO) on a stable surface (SS), (2) eyes closed (EC) on SS, (3) EO on foam surface (FS), (4) EC on FS.
Sensory ratios
Time frame: Three week study period
Sensory ratios will be assessed by the Modified Clinical Test for Sensory Interaction on Balance (MCTSIB; NeuroCom®, Natus Medical Inc., Pleasanton, CA) during quiet stance. The MCTSIB requires the participant to stand upright as stable as possible for 10 s under four different conditions: (1) eyes open (EO) on a stable surface (SS), (2) eyes closed (EC) on SS, (3) EO on foam surface (FS), (4) EC on FS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Vestibular Disorder, run by Clarkson University at 1 site in United States.
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Vestibulo-ocular reflex (VOR) gain (time frame: Three week study period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.