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

Completed · Not applicable

Conditions studied: Vestibular Diseases, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases, Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT01483937

Run by

Karen L Atkins

People needed

32

Starts

2011-11-01

Expected to finish

2013-08-01

Last updated by the study team

2014-06-27

Who can join

Age: 21 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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