Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
NCT ID: NCT03846830
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2021-10-11
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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IVE/VPT 6 week Crossover
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.
Incremental Velocity Error (IVE)
A lightweight headband has electronics attached that detect head velocity and move a laser target at a fraction of the head velocity.
Traditional Vestibular Rehabilitation (VPT)
Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.
IVE/VPT 3 week Crossover
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.
Incremental Velocity Error (IVE)
A lightweight headband has electronics attached that detect head velocity and move a laser target at a fraction of the head velocity.
Traditional Vestibular Rehabilitation (VPT)
Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.
IVE/VPT 3 week crossover
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.
Incremental Velocity Error (IVE)
A lightweight headband has electronics attached that detect head velocity and move a laser target at a fraction of the head velocity.
Traditional Vestibular Rehabilitation (VPT)
Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.
Interventions
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Incremental Velocity Error (IVE)
A lightweight headband has electronics attached that detect head velocity and move a laser target at a fraction of the head velocity.
Traditional Vestibular Rehabilitation (VPT)
Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.
Eligibility Criteria
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Inclusion Criteria
* Service members with mTBI and civilian patients with vestibular hypofunction, both of which reports vestibular symptoms (i.e. dizziness, imbalance).
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fort Belvoir Community Hospital
FED
Neuroscience Research Australia
OTHER
Walter Reed National Military Medical Center
FED
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Michael C Schubert, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Fort Belvoir CH
Fort Belvoir, Virginia, United States
Countries
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References
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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.
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.
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.
Related Links
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Patent for the device being studied
Other Identifiers
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CDMRP-PT170081
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB00182654
Identifier Type: -
Identifier Source: org_study_id