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

NCT01483937 | Completed Results

• 2 other identifiers: 10-221:1.2W81XWH-10-C-0184-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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; 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.

Conditions

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Traumatic Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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 Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT).

  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.

  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 Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT).

  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.

  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 Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT).

  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.

  Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks)

Secondary Outcomes (5)

• Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2

  Pre Test to Post Test 2 after four physical therapy sessions within 10 days

• Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1

  Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days

• Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2

  Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.

• Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4

  Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days

• Head Shake Sensory Organization Test (HS_SOT)

  Pre Test, Post Test 1 and Post Test 4

Study Arms (2)

Usual care physical therapy only

ACTIVE COMPARATOR

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

Usual care physical therapy plus SEMD

EXPERIMENTAL

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

Interventions

Usual care physical therapy plus SEMD DEVICE

Patients will receive usual care physical therapy while wearing SEMD. SEMD protocols will also be provided to device subjects.

Also known as: BalanceSense

Usual care physical therapy plus SEMD

Usual care physical therapy only OTHER

Subjects will receive usual care physical therapy from vestibular and balance specialists.

Usual care physical therapy only

Eligibility Criteria

• Age: 21 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Fluctuating Meniere's
• Vestibular injury requiring surgery such as perilymph fistula
• Moderate progressive neurologic disease such as multiple sclerosis
• Does not speak and understand the English language
• Resides in a nursing home
• Unable to provide own consent.

Sponsors & Collaborators

• Karen L Atkins: lead

Study Sites (4)

England Physical Therapy

Garden Grove, California, 92840, United States

Location

Florida Ear & Balance Center

Celebration, Florida, 34747, United States

Location

Stevenson & Associates Physical Therapy

Fort Myers, Florida, 33908, United States

Location

Brooks Balance Center

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Injuries, Traumatic; Dysequilibrium syndrome; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Limitations and Caveats

Small number of subjects recruited because of lengthy study commitment.

Results Point of Contact

• Title: Karen L. Atkins PhD PT
• Organization: BalanceSense LLC

atkins.balancesense@gmail.com

407 625 9680

Study Officials

• Karen L Atkins, PhD, PT

  BalanceSense LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 27, 2014
• Results First Posted: June 27, 2014

Record last verified: 2014-06

Locations

US (4)