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Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT)

Primary Purpose

Mild Traumatic Brain Injury, Vestibular Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incremental Velocity Error (IVE)
Traditional Vestibular Rehabilitation (VPT)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring gaze stability, balance, vestibulo-ocular reflex (VOR) gain, dizzy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Greater than or equal to 18 years old
  • Service members with mTBI and civilian patients with vestibular hypofunction, both of which reports vestibular symptoms (i.e. dizziness, imbalance).

Exclusion Criteria:

  • Any subjects with a self-reported history of significant ophthalmic, neuromuscular, cardiovascular (except hypertension), renal/electrolyte and psychiatric disorders
  • Those with uncontrolled severe hypertension (systolic BP of >200 mm Hg and/or a diastolic BP of > 110 mmHg at rest)
  • Those with a recent history of alcohol and/or drug abuse within the past 6 months

Sites / Locations

  • Johns Hopkins UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

IVE/VPT 6 week Crossover

IVE/VPT 3 week Crossover

IVE/VPT 3 week crossover

Arm Description

Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 5 weeks, 6 weeks washout, and then crossover into the other group for a final 5 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout each of the 5 weeks epochs of training.

Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training will not start until the washout period.

Subjects will randomly be placed in one of two groups (IVE or VPT) involving every other day exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout the 3 weeks of exercise.

Outcomes

Primary Outcome Measures

Change in vestibulo-ocular reflex (VOR) Gain
A ratio of eye/head velocity measured using a small video camera attached to a lightweight headband. This is an off-the-shelf device commonly used in clinic. Scores typically vary between 0 and 1.2 and normal ranges are between 0.8 and 1.2.

Secondary Outcome Measures

Baseline vestibular function assessed with Videonystagmography/Electronystagmography (VNG/ENG)
The VNG/ENG is a suite of tests that measure oculomotor function and vestibular function by asking subjects to follow moving targets while the eyes are recording with video (VNG) or electrodes (ENG). Also included is a warm and cold air flush into the external ear, which stimulates the 8th cranial nerve. The report includes measures of eye velocity (deg/sec), position, (deg) and acceleration (deg/sec/sec) relative to the moving targets. These data are presented in a plot that is compared to normative values provided by the company to assess baseline vestibular function.
Baseline oculomotor function assessed with Videonystagmography/Electronystagmography (VNG/ENG)
This is a standard clinical test being done to characterize baseline vestibular function. The VNG/ENG is a suite of tests that measure oculomotor function and vestibular function by asking subjects to follow moving targets while the eyes are recording with video (VNG) or electrodes (ENG). Also included is a warm and cold air flush into the external ear, which stimulates the 8th cranial nerve. The report includes measures of eye velocity (deg/sec), position, (deg) and acceleration (deg/sec/sec) relative to the moving targets. Data also includes velocity of eye rotations relative to healthy controls. These data are presented in a plot that is compared to normative values provided by the company to assess baseline oculomotor function.
Baseline vestibular function assessed with Vestibular Evoked Myogenic Potential (VEMP)
This is a standard clinical test being done to characterize baseline vestibular function. The VEMP test uses surface electromyography to record sternocleidomastoid and/or inferior oblique muscle activity. The report output is the latency and magnitude of the muscle response. These data are presented in a plot that is compared to normative values provided by the company to assess baseline vestibular function.
Baseline vestibular function assessed with Rotary Chair
This is a standard clinical test being done to characterize baseline vestibular function. The Rotary Chair test positions subjects in an enclosure, seated in a chair that moves 360deg at 60 and 240 deg/sec. The report includes measures of eye and head velocity (deg/sec) and position (deg). These data are presented in a plot that is compared to normative values provided by the company to assess baseline vestibular function.
Change in Dizziness Handicap Inventory
This is a questionnaire filled out by the subject that includes items describing the behavioral impact of experiencing dizziness/imbalance. Each items is scored as a Likert scale type variable where subjects answer Yes Sometimes or No. Scores range from 0-100, with 0 indicating no impact of dizziness while scores of 100 indicate a severe impact.
Change in Activity Specific Balance Confidence scale (ABC)
Self-report measure that asks subjects to rate their confidence performing 16 activities of daily living. Each item is scored from 0 to 100% in 10% increments with 0% indicating No confidence and 100% indicating Complete confidence.
Change in Neurobehavioral Symptom Inventory (NSI)
This is a 22 item questionnaire that asks how bothersome symptoms are. Items are scored from 0 (None) to 4 (Very Severe). HIgher scores imply the symptoms are more bothersome.
Change in Patient Global Impression of Change (PGIC)
This is a questionnaire filled out by the subject that assesses change in activity, symptoms, emotions, and overall quality of life. Items are between 1 (no change) to 7 (considerable) and higher scores suggest a better change in symptom management.
Change in Dynamic Visual Acuity (DVA)
This is a standard clinical test of visual acuity during active (self-generated) head rotation. Subjects identify letters on a computer monitor; scores range from 20/10 acuity to 20/800 and normative data are available to compare.
Change in Time ( in seconds) Standing during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Subjects stand quietly (arms folded) on the ground or on a compliant surface while time is measured up to 30 seconds. This is a standard measure of standing posture/balance. Each participant gets a score ranging from 0 to 30 seconds with higher scores correlating with a better balance.
Change in Area (in degrees) of Sway during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Subjects stand quietly (arms folded) on the ground or on a compliant surface while sway is measured using small sensors placed on the body (inertial measurement units). The sensors measure amount of sway in degrees and the duration the subject stands is measured for up to 30 seconds. Sway scores range 0 to 20 degrees of motion side to side and fore-aft. Lower scores correlate with a better balance.
Change in the tandem walk test assessed by number of steps taken
Ability to walk heel to toe for a distance of 10 steps.
Change in the time to complete the Timed Up and Go (TUG) Ipsi Turn.
Subjects total time (in seconds) is recorded to stand from seated position, walk 3 meters, turn around 180-degrees and return to sit.
Change in the time to complete the Timed Up and Go (TUG) Contra Turn.
Subjects total time (in seconds) is recorded to stand from seated position, walk 3 meters, turn around 180-degrees and return to sit.
Change in Fogginess (mental) during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The fogginess is rated on a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Change in Dizziness during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The dizziness is on a visual analog scale from from 0 (no symptoms) -10 (worse symptoms).
Change in Headache during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The headache is rated on a a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Change in Nausea during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The nausea is rated on a a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Change in visual acuity during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involving the use of virtual reality goggles and viewing a scenario that mimic a patrolling scenario. Subjects step on/off a 6-inch step while being asked to identify objects in the scene. A subjective rating of visual acuity using a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Change in Mean Reaction Time during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The reaction time (in milliseconds) to respond to 11 auditory cues embedded in the virtual scene is measured.
Change in 5 min heart rate during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The heart rate at 5 minute is measured in beats per minute.
Pre heart rate during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The initial heart rate is measured in beats per minute.
Post (video) heart rate during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The post video completion heart rate is measured in beats per minute.
Final heart rate during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The 3 min post video completion heart rate is measured in beats per minute.
Pre Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. Rate of Perceived Exertion (RPE) is measured on a scale from 6 (rest) - 20 (maximal exertion) scale.
Post (video) Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. Post RPE is measured at the end of the video using the 6 (rest) - 20 (maximal exertion) scale.
5 min Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. RPE is measured at the 5th minute from starting the video using the 6 (rest) - 20 (maximal exertion) scale.
Change in the Functional Gait Assessment (FGA)
The FGA is a 10-item behavioral test assessing risk for fall. Each items is scored from 0 (severe) to 3 (normal) impairment. Scores range from 0 - 30 with scores compared against normative data.

Full Information

First Posted
February 15, 2019
Last Updated
October 9, 2023
Sponsor
Johns Hopkins University
Collaborators
Fort Belvoir Community Hospital, Neuroscience Research Australia, Walter Reed National Military Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03846830
Brief Title
Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
Acronym
INVENT
Official Title
INVENT VPT: Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Fort Belvoir Community Hospital, Neuroscience Research Australia, Walter Reed National Military Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective for this study is to compare outcome measures from vestibular rehabilitation (VPT) delivered in a traditional method against a new device Incremental Velocity Error (IVE) that improves physiologic performance of the vestibulo-ocular reflex. Participants include active duty service members with mild traumatic brain injury (mTBI) and civilians with peripheral vestibular hypofunction. The investigators will use a clinical trial cross-over design with randomization to either the control (VPT) or experimental (IVE) group and measure vestibulo-ocular reflex function as well as subjective and functional outcomes in order to investigate the best means to improve delivery of vestibular rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury, Vestibular Neuropathy
Keywords
gaze stability, balance, vestibulo-ocular reflex (VOR) gain, dizzy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The investigators will randomize placement in two groups of gaze stability exercises (IVE or traditional VPT). Each of the three Aims will recruit active duty service members with mTBI and dizziness from the Intrepid Spirit Center at Fort Belvoir Community Hospital (FBCH) and civilians with unilateral vestibular hypofunction from Johns Hopkins University (JHU). Inclusion criteria for the FBCH site are active duty service member with mTBI and 'vestibular' symptoms (dizziness, oscillopsia, motion sensitivity, imbalance). Inclusion criteria for the JHU site are civilians with unilateral vestibular hypofunction.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVE/VPT 6 week Crossover
Arm Type
Active Comparator
Arm Description
Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 5 weeks, 6 weeks washout, and then crossover into the other group for a final 5 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout each of the 5 weeks epochs of training.
Arm Title
IVE/VPT 3 week Crossover
Arm Type
Experimental
Arm Description
Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training will not start until the washout period.
Arm Title
IVE/VPT 3 week crossover
Arm Type
Active Comparator
Arm Description
Subjects will randomly be placed in one of two groups (IVE or VPT) involving every other day exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout the 3 weeks of exercise.
Intervention Type
Device
Intervention Name(s)
Incremental Velocity Error (IVE)
Intervention Description
A lightweight headband has electronics attached that detect head velocity and move a laser target at a fraction of the head velocity.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Vestibular Rehabilitation (VPT)
Intervention Description
Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.
Primary Outcome Measure Information:
Title
Change in vestibulo-ocular reflex (VOR) Gain
Description
A ratio of eye/head velocity measured using a small video camera attached to a lightweight headband. This is an off-the-shelf device commonly used in clinic. Scores typically vary between 0 and 1.2 and normal ranges are between 0.8 and 1.2.
Time Frame
Weekly, up to 6 months
Secondary Outcome Measure Information:
Title
Baseline vestibular function assessed with Videonystagmography/Electronystagmography (VNG/ENG)
Description
The VNG/ENG is a suite of tests that measure oculomotor function and vestibular function by asking subjects to follow moving targets while the eyes are recording with video (VNG) or electrodes (ENG). Also included is a warm and cold air flush into the external ear, which stimulates the 8th cranial nerve. The report includes measures of eye velocity (deg/sec), position, (deg) and acceleration (deg/sec/sec) relative to the moving targets. These data are presented in a plot that is compared to normative values provided by the company to assess baseline vestibular function.
Time Frame
At first visit, up to 30 minutes.
Title
Baseline oculomotor function assessed with Videonystagmography/Electronystagmography (VNG/ENG)
Description
This is a standard clinical test being done to characterize baseline vestibular function. The VNG/ENG is a suite of tests that measure oculomotor function and vestibular function by asking subjects to follow moving targets while the eyes are recording with video (VNG) or electrodes (ENG). Also included is a warm and cold air flush into the external ear, which stimulates the 8th cranial nerve. The report includes measures of eye velocity (deg/sec), position, (deg) and acceleration (deg/sec/sec) relative to the moving targets. Data also includes velocity of eye rotations relative to healthy controls. These data are presented in a plot that is compared to normative values provided by the company to assess baseline oculomotor function.
Time Frame
At first visit, up to 30 minutes.
Title
Baseline vestibular function assessed with Vestibular Evoked Myogenic Potential (VEMP)
Description
This is a standard clinical test being done to characterize baseline vestibular function. The VEMP test uses surface electromyography to record sternocleidomastoid and/or inferior oblique muscle activity. The report output is the latency and magnitude of the muscle response. These data are presented in a plot that is compared to normative values provided by the company to assess baseline vestibular function.
Time Frame
At first visit, up to 20 minutes.
Title
Baseline vestibular function assessed with Rotary Chair
Description
This is a standard clinical test being done to characterize baseline vestibular function. The Rotary Chair test positions subjects in an enclosure, seated in a chair that moves 360deg at 60 and 240 deg/sec. The report includes measures of eye and head velocity (deg/sec) and position (deg). These data are presented in a plot that is compared to normative values provided by the company to assess baseline vestibular function.
Time Frame
At first visit, up to 40 minutes.
Title
Change in Dizziness Handicap Inventory
Description
This is a questionnaire filled out by the subject that includes items describing the behavioral impact of experiencing dizziness/imbalance. Each items is scored as a Likert scale type variable where subjects answer Yes Sometimes or No. Scores range from 0-100, with 0 indicating no impact of dizziness while scores of 100 indicate a severe impact.
Time Frame
Every other week, up to 6 months
Title
Change in Activity Specific Balance Confidence scale (ABC)
Description
Self-report measure that asks subjects to rate their confidence performing 16 activities of daily living. Each item is scored from 0 to 100% in 10% increments with 0% indicating No confidence and 100% indicating Complete confidence.
Time Frame
Every other week, up to 6 months
Title
Change in Neurobehavioral Symptom Inventory (NSI)
Description
This is a 22 item questionnaire that asks how bothersome symptoms are. Items are scored from 0 (None) to 4 (Very Severe). HIgher scores imply the symptoms are more bothersome.
Time Frame
Every other week, up to 6 months
Title
Change in Patient Global Impression of Change (PGIC)
Description
This is a questionnaire filled out by the subject that assesses change in activity, symptoms, emotions, and overall quality of life. Items are between 1 (no change) to 7 (considerable) and higher scores suggest a better change in symptom management.
Time Frame
Every other week, up to 6 months
Title
Change in Dynamic Visual Acuity (DVA)
Description
This is a standard clinical test of visual acuity during active (self-generated) head rotation. Subjects identify letters on a computer monitor; scores range from 20/10 acuity to 20/800 and normative data are available to compare.
Time Frame
Every other week, up to 6 months
Title
Change in Time ( in seconds) Standing during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Description
Subjects stand quietly (arms folded) on the ground or on a compliant surface while time is measured up to 30 seconds. This is a standard measure of standing posture/balance. Each participant gets a score ranging from 0 to 30 seconds with higher scores correlating with a better balance.
Time Frame
Every other week, up to 6 months
Title
Change in Area (in degrees) of Sway during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Description
Subjects stand quietly (arms folded) on the ground or on a compliant surface while sway is measured using small sensors placed on the body (inertial measurement units). The sensors measure amount of sway in degrees and the duration the subject stands is measured for up to 30 seconds. Sway scores range 0 to 20 degrees of motion side to side and fore-aft. Lower scores correlate with a better balance.
Time Frame
Every other week, up to 6 months
Title
Change in the tandem walk test assessed by number of steps taken
Description
Ability to walk heel to toe for a distance of 10 steps.
Time Frame
Every other week, up to 6 months
Title
Change in the time to complete the Timed Up and Go (TUG) Ipsi Turn.
Description
Subjects total time (in seconds) is recorded to stand from seated position, walk 3 meters, turn around 180-degrees and return to sit.
Time Frame
Every other week, up to 6 months
Title
Change in the time to complete the Timed Up and Go (TUG) Contra Turn.
Description
Subjects total time (in seconds) is recorded to stand from seated position, walk 3 meters, turn around 180-degrees and return to sit.
Time Frame
Every other week, up to 6 months
Title
Change in Fogginess (mental) during the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The fogginess is rated on a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Time Frame
Every other week, up to 6 months
Title
Change in Dizziness during the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The dizziness is on a visual analog scale from from 0 (no symptoms) -10 (worse symptoms).
Time Frame
Every other week, up to 6 months
Title
Change in Headache during the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The headache is rated on a a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Time Frame
Every other week, up to 6 months
Title
Change in Nausea during the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The nausea is rated on a a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Time Frame
Every other week, up to 6 months
Title
Change in visual acuity during the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test involving the use of virtual reality goggles and viewing a scenario that mimic a patrolling scenario. Subjects step on/off a 6-inch step while being asked to identify objects in the scene. A subjective rating of visual acuity using a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Time Frame
Every other week, up to 6 months
Title
Change in Mean Reaction Time during the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The reaction time (in milliseconds) to respond to 11 auditory cues embedded in the virtual scene is measured.
Time Frame
Every other week, up to 6 months
Title
Change in 5 min heart rate during the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The heart rate at 5 minute is measured in beats per minute.
Time Frame
Every other week, up to 6 months
Title
Pre heart rate during the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The initial heart rate is measured in beats per minute.
Time Frame
Every other week, up to 6 months
Title
Post (video) heart rate during the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The post video completion heart rate is measured in beats per minute.
Time Frame
Every other week, up to 6 months
Title
Final heart rate during the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The 3 min post video completion heart rate is measured in beats per minute.
Time Frame
Every other week, up to 6 months
Title
Pre Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. Rate of Perceived Exertion (RPE) is measured on a scale from 6 (rest) - 20 (maximal exertion) scale.
Time Frame
Every other week, up to 6 months
Title
Post (video) Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. Post RPE is measured at the end of the video using the 6 (rest) - 20 (maximal exertion) scale.
Time Frame
Every other week, up to 6 months
Title
5 min Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
Description
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. RPE is measured at the 5th minute from starting the video using the 6 (rest) - 20 (maximal exertion) scale.
Time Frame
Every other week, up to 6 months
Title
Change in the Functional Gait Assessment (FGA)
Description
The FGA is a 10-item behavioral test assessing risk for fall. Each items is scored from 0 (severe) to 3 (normal) impairment. Scores range from 0 - 30 with scores compared against normative data.
Time Frame
Every other week, up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Greater than or equal to 18 years old Service members with mTBI and civilian patients with vestibular hypofunction, both of which reports vestibular symptoms (i.e. dizziness, imbalance). Exclusion Criteria: Any subjects with a self-reported history of significant ophthalmic, neuromuscular, cardiovascular (except hypertension), renal/electrolyte and psychiatric disorders Those with uncontrolled severe hypertension (systolic BP of >200 mm Hg and/or a diastolic BP of > 110 mmHg at rest) Those with a recent history of alcohol and/or drug abuse within the past 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Millar, MSPT
Phone
410-955-0016
Email
jmillar1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Schubert, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael C Schubert, PhD
Phone
410-955-3403
Email
mschube1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Millar, MS PT
Phone
4109550016
Email
jmillar1@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will only share de-identified individual participant data (IPD) with researchers on the approved research protocol.
Citations:
PubMed Identifier
29877847
Citation
Todd CJ, Hubner PP, Hubner P, Schubert MC, Migliaccio AA. StableEyes-A Portable Vestibular Rehabilitation Device. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1223-1232. doi: 10.1109/TNSRE.2018.2834964.
Results Reference
background
PubMed Identifier
25122595
Citation
Migliaccio AA, Schubert MC. Pilot study of a new rehabilitation tool: improved unilateral short-term adaptation of the human angular vestibulo-ocular reflex. Otol Neurotol. 2014 Dec;35(10):e310-6. doi: 10.1097/MAO.0000000000000539.
Results Reference
background
PubMed Identifier
34895314
Citation
Ervin AM, Schubert MC, Migliaccio AA, Perin J, Coulibaly H, Millar JL, Roberts D, Shelhamer M, Gold D, Beauregard S, Pinto R, Brungart D, Ward BK; INVENT VPT Research Group. Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial. Trials. 2021 Dec 11;22(1):908. doi: 10.1186/s13063-021-05876-4.
Results Reference
derived
Links:
URL
https://www.google.com/patents/US20100198104
Description
Patent for the device being studied

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Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation

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