Clinical Trial: Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Trial Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium

Brief 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;

Detailed Summary:

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.

Current Primary Outcome:

• Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT). [ Time Frame: Pre Test to Post Test 1 after two physical therapy sessions (one week) ]
  Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
• Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT). [ Time Frame: Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks) ]
  Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
• Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT). [ Time Frame: Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks) ]
  Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
• Assessment of the Efficacy of the SEMD
  
  

  Original Primary Outcome:

  • Sensory Organization Test (SOT) [ Time Frame: Pre Test to Post Test 1 after two physical therapy sessions (one week) ]
    Assessment of the efficacy of the SEMD device in improving vestibular function will be evaluated with pre test to post test 1 Sensory Organization Test (SOT.)
  • Sensory Organization Test (SOT) [ Time Frame: Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks) ]
    Assessment of the efficacy of the SEMD device in improving vestibular function will be evaluated with pre test to post test 2, and post test 1 to post test 2 Sensory Organization Test (SOT.)
  • Sensory Organization Test (SOT) [ Time Frame: Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks) ]
    Assessment of the efficacy of the SEMD device in improving vestibular function will be evaluated with pre test to post test 3, and post test 2 to post test 3 Sensory Organization Test (SOT.)
  • Sensory Organization Test (SOT) [ Time Frame: Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks) ]
    Assessment of the efficacy of the SEMD device in improving vestibular function will be evaluated with pre test to post test 4, and post test 3 to post test 4 Sensory Organization Test (SOT.)
  
  
  

  Current Secondary Outcome:

  • Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2 [ Time Frame: Pre Test to Post Test 2 after four physical therapy sessions within 10 days ]

    Functional Gait Assessment is a 10-item gait assessment based on the Dynamic Gait Index. Requirements: A marked 20 foot walkway that is marked with a 12 inch width. Scoring: a four-point ordinal scale, ranging from 0-3 where "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 30 with higher score indicating safer ambulation with lower risk of falling.

    Criterion Validity: "Authors support a cut off score of 23/30 for independent safe ambulation".

    Interpretation: 1) 0-19 is predictive of falls in the elderly. 2) 20-22 indicates likelihood of unexplained fall in community-dwelling, older adults, and predictive of likelihood of falling in patients with vestibular disorders.

    3) 23-30 = safe ambulators

  • Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1 [ Time Frame: Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days ]
    A fall is an unintentional change in position causing an individual to land at a lower level, on an object, the floor, the ground or other surface with or without injury. This includes: slips, trips, falling into other people, being lowered, loss of balance, and legs giving way. (Exclude sudden onset of paralysis, epileptic seizure, or overwhelming external force.)
  • Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2 [ Time Frame: Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days. ]

    Berg Balance Scale Description: 14-item scale designed to measure balance of the older adult in a clinical setting, and measures mobility related to activities of daily living. Description: This 14-item performance-based instrument is intended for individuals with some degree of balance impairment.

    Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56 with higher score indicting safer ambulation with lower risk of falling.

    Criterion Validity: "Authors support a cut off score of 45/56 for independent safe ambulation".

    Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk

    Riddle and Stratford, 1999, examined 45/56 cutoff validity and concluded:

    • Sensitivity = 64% (Correctly predicts fallers)
    • Specificity = 90% (Correctly predicts non-fallers)
  • Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4 [ Time Frame: Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days ]
    Vestibular Rehabilitation Benefit Questionnaire asks the patient to self-rate disability as it affects their quality of life. Scale goes from zero, no disability, to 100 or maximal disability. The Total Benefit includes two subsets: 1) dizziness symptoms, and 2) quality of life.
  • Head Shake Sensory Organization Test (HS_SOT) [ Time Frame: Pre Test, Post Test 1 and Post Test 4 ]

    Head Shake Sensory Organization Test (HS-SOT)

    HS-SOT instructs the patient to static stand shoulder width apart with eyes closed and uses the SOT Condition 5 sway surface protocol while shaking the head horizontally 120 degrees per second. This protocol is safe for patients when they have normalized all SOT scores. Because study subjects were reaching SOT normalization after Post Test 2, the data collected was scant and not suitable for analysis.

  
  
  

  Original Secondary Outcome:

  • Functional Gait Assessment [ Time Frame: Pre Test, Post Test 1 after two physical therapy sessions, Post Test 2 after four physical therapy sessions, Post Test 3 after eight physical therapy sessions, and Post Test 4 after twelve physical therapy sessions ]
    Measurements of transfer of skill(s) to activities of daily living.
  • Self-report Fall(s) Occurrence and Duty/Work Status [ Time Frame: Pre Test, Post Tests 1-5 as above, Phone Follow-up 1 two weeks post intervention, Phone Follow-up 2 eight weeks post intervention, Phone Follow-up 3 eighteen weeks post intervention ]
    Skill retention will be evaluated pre intervention to post intervention with a questionnaire devised for this study.
  • Berg Balance Scale [ Time Frame: Pre Test, Post Test 2, Post Test 4 ]
    Measurement of transfer of skills to activities of daily living.
  • Vestibular Rehabilitation Benefit Questionnaire [ Time Frame: Pre Test, Post Test 4 ]
    Self rated measurement of perceived quality of life.
  • Head Shake Sensory Organization Test (HS_SOT) [ Time Frame: Pre Test, Post Test 1 and Post Test 4 ]
    Secondary outcome measurement of vestibular function.
  
  
  Information By: BalanceSense LLC
  

  Dates:
  Date Received: November 30, 2011
  Date Started: November 2011
  Date Completion:
  Last Updated: June 26, 2014
  Last Verified: June 2014