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

NCT ID: NCT01483937

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-08-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Usual care physical therapy only

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Usual care physical therapy plus SEMD

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Usual care physical therapy only

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

Intervention Type: OTHER

Other Intervention Names

BalanceSense

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karen L Atkins

INDUSTRY

Sponsor Role: lead

Responsible Party

Karen L Atkins

Study Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Karen L Atkins, PhD, PT

Role: STUDY_DIRECTOR

BalanceSense LLC

Locations

England Physical Therapy

Garden Grove, California, United States

Florida Ear & Balance Center

Celebration, Florida, United States

Stevenson & Associates Physical Therapy

Fort Myers, Florida, United States

Brooks Balance Center

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

W81XWH-10-C-0184-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

10-221:1.2

Identifier Type: -

Identifier Source: org_study_id