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Concurrent Vestibular Activation and Postural Training Using Virtual Reality (VR-HS-WST)

Primary Purpose

Vestibular Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vestibular training using VR followed by Control
Control followed by Vestibular training using VR
Sponsored by
Clarkson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vestibular Disorder focused on measuring sensory reweighting, vestibular rehabilitation, vestibular reflex, virtual reality

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Vestibular activation training

    No training

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2023
    Last Updated
    August 26, 2023
    Sponsor
    Clarkson University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05942781
    Brief Title
    Concurrent Vestibular Activation and Postural Training Using Virtual Reality
    Acronym
    VR-HS-WST
    Official Title
    Effects of Concurrent Vestibular Activation and Postural Training on Postural Control Using Virtual Reality
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Clarkson University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vestibular Disorder
    Keywords
    sensory reweighting, vestibular rehabilitation, vestibular reflex, virtual reality

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vestibular activation training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    No training
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Vestibular training using VR followed by Control
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Control followed by Vestibular training using VR
    Intervention Description
    Group two will follow the reverse sequence.
    Primary Outcome Measure Information:
    Title
    Vestibulo-ocular reflex (VOR) gain
    Description
    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.
    Time Frame
    Three week study period
    Title
    Eye movement variability
    Description
    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.
    Time Frame
    Three week study period
    Title
    Electromyography (EMG) amplitude
    Description
    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.
    Time Frame
    Three week study period
    Title
    Electromyography (EMG) time onset
    Description
    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.
    Time Frame
    Three week study period
    Title
    Balance equilibrium and composite scores
    Description
    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.
    Time Frame
    Three week study period
    Title
    Sensory ratios
    Description
    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.
    Time Frame
    Three week study period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Concurrent Vestibular Activation and Postural Training Using Virtual Reality

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