- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05942781
Concurrent Vestibular Activation and Postural Training Using Virtual Reality (VR-HS-WST)
June 15, 2025 updated by: Kwadwo Appiah-Kubi, Clarkson University
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- 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
-
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New York
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Potsdam, New York, United States, 13699
- Clarkson Hall
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-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vestibular activation training
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.
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Group two will follow the reverse sequence.
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.
|
|
No Intervention: No training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Three week study period
|
|
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.
|
Three week study period
|
|
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.
|
Three week study period
|
|
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.
|
Three week study period
|
|
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.
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Three week study period
|
|
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.
|
Three week study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 15, 2024
Primary Completion (Actual)
December 30, 2024
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
March 23, 2023
First Submitted That Met QC Criteria
July 10, 2023
First Posted (Actual)
July 12, 2023
Study Record Updates
Last Update Posted (Actual)
June 18, 2025
Last Update Submitted That Met QC Criteria
June 15, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-30
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.
No
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.