Concurrent Vestibular Activation and Postural Training Using Virtual Reality

NCT05942781 | Active Not Recruiting FDA Device

• 1 other identifier: 23-30
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

sensory reweighting; vestibular rehabilitation; vestibular reflex; virtual reality

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Three week study period

Study Arms (2)

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.

Device: Vestibular training using VR followed by Control; Device: Control followed by Vestibular training using VR

No training

NO INTERVENTION

Interventions

Vestibular training using VR followed by Control DEVICE

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.

Vestibular activation training

Control followed by Vestibular training using VR DEVICE

Group two will follow the reverse sequence.

Vestibular activation training

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clarkson University: lead

Study Sites (1)

Clarkson Hall

Potsdam, New York, 13699, United States

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: July 12, 2023
• Study Start: April 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: September 1, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

US (1)