Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial

Trials

Stephanie Beauregard¹  Ann-Margret Ervin²  Hamadou Coulibaly²  Jamie Perin²  Dale Roberts³  Jennifer L. Millar⁴  Mark Shelhamer⁴  Bryan K. Ward⁴  Michael C. Schubert⁴  Daniel Gold⁴  Douglas Brungart⁵  Robin Pinto⁵  Americo A. Migliaccio⁶ 

[1] Intrepid Spirit Center, Fort Belvoir Community Hospital, Intrepid Pavilion, 5980 9th Street, Bldg. 1259, 22060, Fort Belvoir, VA, USA;Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, 21205, Baltimore, MD, USA;Johns Hopkins University School of Medicine, 1800 Orleans Street, 21287, Baltimore, MD, USA;Johns Hopkins University School of Medicine, 601 N. Caroline Street, 21287, Baltimore, MD, USA;National Military Audiology and Speech Center, Walter Reed National Military Medical Center, Building 19, Room 5600, 4954 North Palmer Rd, 20889-5630, Bethesda, MD, USA;Neuroscience Research Australia, Sydney, Australia;

关键词: Vestibular rehabilitation;    Vestibulo-ocular reflex;    Dizziness;    Incremental vestibular adaptation;    Imbalance;    Service members, Traumatic brain injury;   

DOI  :  10.1186/s13063-021-05876-4

来源: Springer

【 摘 要 】

BackgroundA clinical pattern of damage to the auditory, visual, and vestibular sensorimotor systems, known as multi-sensory impairment, affects roughly 2% of the US population each year. Within the population of US military service members exposed to mild traumatic brain injury (mTBI), 15–44% will develop multi-sensory impairment following a mild traumatic brain injury. In the US civilian population, multi-sensory impairment-related symptoms are also a common sequela of damage to the vestibular system and affect ~ 300–500/100,000 population. Vestibular rehabilitation is recognized as a critical component of the management of multi-sensory impairment. Unfortunately, the current clinical practice guidelines for the delivery of vestibular rehabilitation are not evidence-based and primarily rely on expert opinion. The focus of this trial is gaze stability training, which represents the unique component of vestibular rehabilitation. The aim of the Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) trial is to assess the efficacy of a non-invasive, incremental vestibular adaptation training device for normalizing the response of the vestibulo-ocular reflex.MethodsThe INVENT VPT Trial is a multi-center randomized controlled crossover trial in which military service members with mTBI and civilian patients with vestibular hypofunction are randomized to begin traditional vestibular rehabilitation or incremental vestibular adaptation and then cross over to the alternate intervention after a prescribed washout period. Vestibulo-ocular reflex function and other functional outcomes are measured to identify the best means to improve the delivery of vestibular rehabilitation. We incorporate ecologically valid outcome measures that address the common symptoms experienced in those with vestibular pathology and multi-sensory impairment.DiscussionThe INVENT VPT Trial will directly impact the health care delivery of vestibular rehabilitation in patients suffering from multi-sensory impairment in three critical ways: (1) compare optimized traditional methods of vestibular rehabilitation to a novel device that is hypothesized to improve vestibulo-ocular reflex performance, (2) isolate the ideal dosing of vestibular rehabilitation considering patient burden and compliance rates, and (3) examine whether recovery of the vestibulo-ocular reflex can be predicted in participants with vestibular symptoms.Trial registrationClinicalTrials.gov NCT03846830. Registered on 20 February 2019.

【 授权许可】

CC BY