- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05941039
Effects of Vestibular Training on Postural Control of Healthy Adults Using Virtual Reality
June 15, 2025 updated by: Kwadwo Appiah-Kubi, Clarkson University
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.
Young healthy participants will perform the training by donning a virtual reality headset 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
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
30
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 Contact
- Name: Kwadwo Appiah-Kubi, PhD
- Phone Number: 347-284-9986
- Email: kappiahk@clarkson.edu
Study Contact Backup
- Name: Evan Laing, BS
- Phone Number: 518-860-9789
- Email: lainge@clarkson.edu
Study Locations
-
-
New York
-
Potsdam, New York, United States, 13699
- Recruiting
- Clarkson University
-
Contact:
- Kwadwo Appiah-Kubi, PhD
- Phone Number: 347-284-9986
- Email: kappiahk@clarkson.edu
-
Contact:
- Evan Laing, BS
- Phone Number: 518-860-9789
- Email: lainge@clarkson.edu
-
-
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
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 within the age of 18-35.
- A power analysis revealed that a sample of 24 participants will required for a two-group comparison to detect a significant difference at alpha=0.05 and 0.30 effect size at beta=0.8 (G*Power, Version 3.0.10)(Faul et al, 2007).
Exclusion Criteria:
- Participants with an 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 on the computer monitor. 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 6 days, a 4-day washout period, and a 6-day no-training period.
Group two will follow the reverse sequence.
|
|
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: Two 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
|
Two week study period
|
|
Eye movement variability
Time Frame: Two 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.
|
Two week study period
|
|
Electromyography (EMG) amplitude
Time Frame: Two 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.
|
Two week study period
|
|
Electromyography (EMG) time onset
Time Frame: Two 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.
|
Two week study period
|
|
Balance equilibrium and composite scores
Time Frame: Two 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.
|
Two week study period
|
|
Sensory ratios
Time Frame: Two 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.
|
Two week study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
October 3, 2022
Primary Completion (Actual)
August 15, 2024
Study Completion (Estimated)
August 30, 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 17, 2025
Last Update Submitted That Met QC Criteria
June 15, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20-25
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
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