Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation
Condition: Traumatic Brain Injury; Vestibular Deficits
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The goal of this clinical research study at RIC is to determine the value and benefit of the
      SK multimodal balance training system through independent clinical evaluations. The
      functional benefit of the SK Balance system will be measured by any improvements in balance
      and functional assessments.

      This study is primarily funded through Engineering Acoustics as a subcontract for a phase II
      Small Business Innovation Research by the Department of Defense.

      3) Hypotheses & Research Objectives and Purpose:

      The specific research questions to be addressed are:

        1. How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT
           intervention on balance and functional gait measures in mild traumatic brain injury
           (mTBI) participants.

        2. How do SKBS measurement tools compare to standard clinical assessments of gait and
           balance in mTBI patients The purpose of this clinical research study is to compare the
           value and benefit of the SK multimodal balance training system in combination with
           traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone
           through independent clinical evaluations. The functional benefit of the SK Balance
           system will be measured by any improvements in clinical measures of balance, functional
           mobility, and gait assessment.
    

Detailed description: 
      Traumatic brain injury (TBI) occurs when physical trauma causes temporary or permanent
      neurological damage. In some cases, symptoms can continue over time and contribute to
      disability. Dizziness and vertigo are associated with nearly all reported studies of mild
      Traumatic Brain Injury (mTBI) and are a significant and functionally limiting component of
      the overall disability.

      TBI is one of the many risks faced by military personnel in combat activities . In a RAND
      Corporation survey of service members who had been deployed to Iraq or Afghanistan, 19%
      reported probable TBI. Dizziness and vertigo are associated with nearly all reported studies
      of mTBI and are a significant and debilitating component of the overall disability. mTBI are
      currently caused by both blast and impact injuries resulting in variable disabilities . Overt
      symptoms may include balance and spatial disorientation problems (vertigo) related to
      vestibular dysfunction, vision disturbances, inner-ear edema, and/or other sensory
      integration deficits.

      Treatment of this particular population group has several challenges which include: 1)
      difficulty with early and specific injury assessment 2) the determination of appropriate
      return-to-duty measures 3) selection of effective individualized balance rehabilitation and
      treatment tools 4) Prolonged length of rehabilitation and uncertain measureable endpoints.
      The group is also highly variable in the nature and extent of balance deficits and cognitive
      and / or related psychological impairments. It appears that almost all subjects with mTBI
      show some susceptibility to vestibular or vestibular/ocular disorders.

      After assessment of disequilibrium, rehabilitation is often a course of remedial physical
      therapy (PT). To affect change in mobility by standard physical therapy, sensory and motor
      systems are "habituated" through exercise, with hope of rehabilitating the system and
      "compensating" by instructing the patient to alter skill sets associated with a task.
      Compensation (without immediate sensory feedback) is problematic and prone to patient (and
      caregiver) interpretation and error, because it may not address the underlying problems and
      may not have long term therapeutic benefits. There is also a very limited pool of PTs who
      specialize in the treatment of neurological problems resulting from brain injuries.
      Individual vestibular rehabilitation treatment programs are designed by these specialist PTs
      who also monitor and participate in each patient's recovery. This approach is labor
      intensive, time consuming (up to 14 weeks of therapy is often needed) and some patients do
      not recover fully .

      The overall objective of this research effort is to use novel combinations of multi-modal
      sensory guided feedback (especially tactile) and traditional vestibular rehabilitation to
      retrain military personnel suffering balance disorders as a result of mTBI. The investigators
      therapeutic goal is to test technology that will return the patient, in the shortest period
      of time, to a level of balance performance consistent with return to the community and/or
      military duty.

      The sense of touch is intrinsically linked with the neuro-motor channel, both at the reflex
      and higher cognitive regions, which makes it uniquely tied to orientation and localization.
      Vibrotactile arrays are therefore intuitive and are an effective sensory feedback pathway.

      Recent research has also demonstrated that tactile cueing yield significantly faster and more
      accurate performance than comparable spatial auditory cues. Further research has demonstrated
      this finding is relatively stable across a variety of body orientations, even when spatial
      translation is required and under physiological stress.

      Over a Phase I SBIR and current Phase II effort, Engineering Acoustics Inc. has developed the
      Sensory Kinetics (SK) Balance System. In the SK system, patients move on a force platform
      (see Figure 1) while movement and posture data is interpreted by advanced software a mapped
      to a wearable vibrotactile belt array and visual display. Vibrotactile cueing provides
      continuous and instantaneous feedback to the patient that compliments their postural and
      mobility decisions. The investigators believe that vibrotactile feedback can greatly increase
      spatial awareness and consequently mobility. Further, the ability of the brain to re-organize
      and relearn functional movement activities provides an intriguing potential pathway for the
      retention of learned functional mobility strategies.Vibrotactile cueing involves short
      duration bursts of mechanical vibration from actuators, or tactors, that are mounted within a
      torso worn belt. The person's position is measured and calculated using a force plate sensor
      and camera sensors. The computerized system is then used as part of physical therapy balance
      training to improve the patient's balance and potentially reduce their risk of falling.
    

Intervention name(s): Sensory Kinetics Balance System; Traditional Vestibular Rehabilitation
Intervention type(s): Device; Other
Intervention description(s): Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.; Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TBI,; vestibular