Use of a Vibrotactile Balance Belt System for Vestibular Rehabilitation in the Pediatric Population
Condition: Vestibular Diseases
MeSH terms: Vestibular Diseases
Study type: Interventional

Summary: 
      The investigators aim to compare rehabilitation progress between control patients who will
      undergo routine vestibular rehabilitation exercises and experimental patients who will
      undergo exercises using a vibrotactile balance belt (SKBRS - Sensory Kinetics Balance
      Rehabilitation System) in addition to their routine vestibular rehabilitation regimen during
      recovery from diseases affecting the vestibular system. The results of this pilot study will
      help to determine if the vibrotactile balance belt is a useful supplement to traditional
      vestibular rehabilitation techniques in children suffering from vestibular impairment.
    

Detailed description: 
      The investigators will conduct a randomized pilot trial to examine the efficacy of the
      vibrotactile balance belt on vestibular rehabilitation in the pediatric population. All
      consented patients will be randomly allocated by a statistician to either the experimental
      group where participants will undergo SKBRS exercises in addition to their routine vestibular
      rehabilitation regimen, or to the control group where participants will undergo routine
      vestibular rehabilitation exercises without the SKBRS.

      All subjects will undergo weekly vestibular rehabilitation sessions for 3 months (a total of
      12 sessions). During these sessions, standard balance training exercises will be done at the
      discretion of the therapists. Experimental subjects will also undergo 15 minutes of SKBRS
      exercises during each standard vestibular rehabilitation session. This device uses
      video-based exercises and a non-invasive vibrotactile belt to measure the subject's position
      in space and trunk tilt/sway while performing various balance tasks.

      All subjects will undergo the following 3 routine tests throughout the course of the therapy
      to determine their progress: The Balance Error Scoring System (BESS) to measure the subject's
      static balance, the Clinical Test of Sensory Integration and Balance (CTSIB), an office-based
      version of the computerized dynamic posturography test, and the Dynamic Gait Index (DGI),
      which measures dynamic balance. Finally, the investigators will ask all subjects to provide
      their subjective opinion of their vestibular rehabilitation program and their opinion of the
      SKBRS by filling out questionnaires.

      The primary outcome measure is a comparison of relative balance improvement between subjects
      who underwent standard vestibular rehabilitation exercises and those who underwent additional
      therapy with the SKBRS during their rehab sessions. This progress will be measured by the
      degree of change in the BESS, CTSIB, and DGI scores between subjects' first and final
      vestibular rehabilitation sessions. The secondary outcome will be the subjects' subjective
      assessments of the effectiveness of their vestibular rehabilitation (measured by the VRBQ) as
      well as the experimental subjects' feedback on the SKBRS device (measured by the SKBRS
      feedback survey).
    

Intervention name(s): Vestibular Rehabilitation/Balance Belt; Standard Vestibular Rehabilitation
Intervention type(s): Device; Other
Intervention description(s): With this device, a subject stands on a force platform on the ground, which measures his/her center of pressure. Additionally, there is laptop displaying the video-based exercise programs and a camera that senses the subject's linear sway, roll, and pitch. Information about the subject's position is transmitted via Bluetooth technology to a non-invasive vibrotactile belt which fits comfortably around the subject's waist, over his/her clothing. Using the Sensory Kinetics software, the subject will play a series of games projected on the laptop screen, which prompt him/her to sway in various directions while keeping both feet planted on the force platform.; This is the standard three-month vestibular rehabilitation therapy that patients are routinely referred to at Boston Children's Hospital.
Other intervention name(s): Sensory Kinetics Balance Rehabilitation System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment