Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
Condition: Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Traumatic Brain Injury
MeSH terms: Ear Diseases; Vestibular Diseases; Otorhinolaryngologic Diseases; Labyrinth Diseases; Labyrinthitis; Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment
      Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance
      physical therapy for rehabilitation of patients who fall as a result of vestibular inducted
      disequilibrium.

      Study participants will receive regular physical therapy, and some will use the SEMD device
      while receiving usual care vestibular-balance physical therapy. The device is an elastic belt
      that holds eight small battery powered vibrating disks. When using the device, you will sit
      or stand on a force platform that measures body sway. That movement information is sent to a
      computer which then sends the information to you via the vibrating disks. The vibrating disks
      are similar to a vibrating cell phone: you can feel the vibration but it is not
      uncomfortable. You can also see your sway movement on the computer screen. Some tests and
      activities will be paced with a beeping sound.

      The aim of this study is six-fold: 1. Demonstrate the relative efficiency between SEMD and
      conventional vestibular-balance physical therapy as reported by treating physical therapists'
      by counting number of skills acquired in a treatment session, and the amount of time needed
      to acquire the skill; 2. Demonstrate greater improvement earlier on in balance test scores
      when using the SEMD as an adjunct to conventional vestibular-balance physical therapy; 3.
      Determine the difference in vestibular habituation between physical therapy plus SEMD and
      conventional vestibular-balance physical therapy; 4. Demonstrate a more immediate reduction
      in fall occurrence when using SEMD as an adjunct to conventional vestibular-balance physical
      therapy; 5. Determine the patient's perception of quality of life between physical therapy
      plus SEMD and conventional vestibular-balance physical therapy; 6. Determine difference in
      acquisition of large movement tasks of tandem walk, step quick-turn, and kneel-shoulder
      rifle-return to stand between subjects that have trained with SEMD and conventional
      vestibular-balance physical therapy .

      In addition to primary and secondary outcome measurements, efficiency of skill acquisition,
      devised for this study, will be evaluated by tracking the number of skills and length of time
      needed to acquire each skill for each physical therapy session using the Patient Skill
      Acquisition Chart (PSAC). Usefulness of Tandem Walk, Step Quick-turn, and Kneel- Shoulder
      Rifle-Return to Stand as intervention outcome, also devised for this study, will be evaluated
      with pre test to post tests Modified Functional Independence Measure - Motor (MFIM-Motor).
      These measurements were devised for this study, and will be evaluated for informational
      purposes only.
    

Detailed description: 
      This study will compare two approaches of physical therapy intervention within vestibular
      deficit populations that frequently fall: 1. physical therapy plus SEMD, and 2. usual care
      physical therapy only.

      Multimodal sensory cueing gives additional or enriched information to complement postural and
      mobility decisions. SEMD displays combine vibrotactile, visual and audio cueing that are
      intuitive and non-intrusive within a balance training system.

      Study intervention includes a maximum of 12 physical therapy intervention sessions, 2 times
      per week for 6 weeks or normalization of SOT, whichever occurs first. Usual care physical
      therapy prescriptions are written specific for number of sessions over a specific duration of
      time. Discharge from physical therapy occurs when number of sessions within a specified
      period of time is exhausted or goals specified by the physical therapist are met. Data
      collection includes 1 pre test and 4 post tests at intervals during the weeks of
      intervention, plus 3 follow-up phone interviews at specified intervals after intervention for
      maximal study duration of 6 months. A patient must attend at least 4 physical therapy
      intervention sessions for their data to be used and for the follow-up phone interviews to be
      initiated.
    

Intervention name(s): Usual care physical therapy plus SEMD; Usual care physical therapy only
Intervention type(s): Device; Other
Intervention description(s): Patients will receive usual care physical therapy while wearing SEMD. SEMD protocols will also be provided to device subjects.; Subjects will receive usual care physical therapy from vestibular and balance specialists.
Other intervention name(s): BalanceSense
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Keywords provided by BalanceSense, LLC:; Physical Therapy; Rehabilitation; Disequilibrium; Balance dysfunction or disorder; Vestibular; Mild Traumatic Brain Injury (mTBI); Vibrotactile