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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen L Atkins, BalanceSense LLC
ClinicalTrials.gov Identifier:
NCT01483937
First received: November 30, 2011
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Traumatic Brain Injury
Device: Usual care physical therapy plus SEMD
Other: Usual care physical therapy only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium

Resource links provided by NLM:


Further study details as provided by BalanceSense LLC:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 From Post Test 3 to Post Test 4 Sensory Organization Test (SOT). [ Time Frame: Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 32
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care physical therapy only
Subjects will receive usual care physical therapy intervention provided by vestibular and balance specialists. Usual care physical therapy, in general, includes but is not limited to static and dynamic balance activities with or without head movements on firm floor or compliant surfaces.
Other: Usual care physical therapy only
Subjects will receive usual care physical therapy from vestibular and balance specialists.
Experimental: Usual care physical therapy plus SEMD
Subjects will receive usual care physical therapy intervention provided by vestibular balance specialists while using the Sensory Enrichment Multimodal Device (SEMD). SEMD protocols use visual, vibrotactile, and auditory cueing referenced to subject's Center of Gravity (COG) and/or Sum of Pressure (SOP) data collected from a force platform upon which the subject is placed. Static and dynamic balance activities with or without head movement are preformed while watching a computer screen; paced with an auditory metronome; and cued by "touch" vibration via coin tactors imbedded in a belt worn around the waist matching the COG/SOP data display.
Device: Usual care physical therapy plus SEMD
Patients will receive usual care physical therapy while wearing SEMD. SEMD protocols will also be provided to device subjects.
Other Name: BalanceSense

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.

  Eligibility

Ages Eligible for Study:   21 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Self-reporting 2 or more falls with or without injury within the past 6 months.
  2. Below normal SOT containing a abnormal vestibular score.
  3. Potential to benefit from physical therapy as indicated by physician prescription referral.
  4. Able to sit and to stand unaided for 2 minutes.
  5. Willing and able to complete all testing, training, and follow-up evaluations required by the study protocol.

Exclusion Criteria:

  1. Fluctuating Meniere's
  2. Vestibular injury requiring surgery such as perilymph fistula
  3. Moderate progressive neurologic disease such as multiple sclerosis
  4. Does not speak and understand the English language
  5. Resides in a nursing home
  6. Unable to provide own consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483937

Locations
United States, California
England Physical Therapy
Garden Grove, California, United States, 92840
United States, Florida
Florida Ear & Balance Center
Celebration, Florida, United States, 34747
Stevenson & Associates Physical Therapy
Fort Myers, Florida, United States, 33908
Brooks Balance Center
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
Karen L Atkins
Investigators
Study Director: Karen L Atkins, PhD, PT BalanceSense LLC
  More Information

No publications provided

Responsible Party: Karen L Atkins, Study Director, BalanceSense LLC
ClinicalTrials.gov Identifier: NCT01483937     History of Changes
Other Study ID Numbers: 10-221:1.2, W81XWH-10-C-0184-01
Study First Received: November 30, 2011
Results First Received: August 19, 2013
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by BalanceSense LLC:
Keywords provided by BalanceSense, LLC:
Physical Therapy
Rehabilitation
Disequilibrium
Balance dysfunction or disorder
Vestibular
Mild Traumatic Brain Injury (mTBI)
Vibrotactile

Additional relevant MeSH terms:
Ear Diseases
Labyrinth Diseases
Labyrinthitis
Otorhinolaryngologic Diseases
Vestibular Diseases
Brain Injuries
Mental Retardation
Wounds and Injuries
Otitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014