Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Condition: Vestibular Disorder; Dizziness
MeSH terms: Vertigo; Vestibular Diseases; Dizziness
Study type: Interventional

Summary: 
      The goal of this study is to evaluate a tactile prosthesis that provide individuals who have
      demonstrated chronic imbalance with help to maintain a correct sense of orientation with
      respect to the gravity and improve posture control.
    

Detailed description: 
      The goal of this study is to evaluate a tactile prosthesis that provide individuals who have
      demonstrated chronic imbalance with help to maintain a correct sense of orientation with
      respect to the gravity and improve posture control. Chronic imbalance leads to significant
      problems. This study is designed to evaluate a device which can potentially improve the
      balance of these patients.

      The participant will be asked to come to Washington University on three occasions for
      approximately 2 hours. Between visits, they will be asked to use the device daily
      (intervention condition) or to not use the device (control condition) for a prescribed period
      of time doing different activities. They will be provided written instructions from a
      physical therapist that will be determined by their individual ability. The activities will
      be typical exercises that are given to people with balance disorders. After 6 weeks of home
      use, participants will return for the second visit, and will repeat the evaluation. They will
      then return home and complete the either the control or intervention condition (which was not
      done the first time) in a crossover design.

      On their first visit (week 0; baseline) participants will be asked to complete the same kind
      of tests that evaluated the function of their balance system at the time of their diagnosis.
      They will have their eye movements recorded using goggles and an infra-red camera while the
      prosthesis is in place and providing vibration feedback. Computerized Dynamic Posturography
      (CDP) testing will require them to stand on a platform and perform tests (20 seconds each)
      with their eyes open or closed, with the platform moving or still, and/or with the visual
      surround either stable or moving. They will be fitted with a safety harness that will keep
      them from falling. Next the investigators will evaluate their ability to perform movement
      tasks while walking (walking down the hall, walking down the hall avoiding objects, changing
      speeds while walking, going up and down stairs etc). They will walk a 25-foot distance at a
      comfortable gait speed, and again at a maximum gait speed. Lastly, they will be asked to fill
      out questionnaires.

      On their second and last visit, they will repeat the evaluations that were performed during
      the first visit.
    

Intervention name(s): BALCAP prosthesis
Intervention type(s): Device
Intervention description(s): The noninvasive BALCAP prosthesis offers uses six degrees-of-freedom (6-DOF) sensing to detect postural imbalance and actuate low-amplitude vibrotactile cues directly to the head to provide the wearer with feedback concerning head tilt in the pitch and roll plane.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Postural Instability; Balance Disorder; Balance Prosthesis; Dizziness