Clinical trial NCT01483937: Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
Official title: Clinical Trial Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: BalanceSense LLC
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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).
timeFrame: Pre Test to Post Test 1 after two physical therapy sessions (one week)
measure: 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).
timeFrame: Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks)
measure: 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).
timeFrame: Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks)
measure: 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).
timeFrame: Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks)
Secondary outcomes:
measure: Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2
timeFrame: Pre Test to Post Test 2 after four physical therapy sessions within 10 days
measure: Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1
timeFrame: Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days
measure: Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2
timeFrame: Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.
measure: Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4
timeFrame: Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days
measure: Head Shake Sensory Organization Test (HS_SOT)
timeFrame: Pre Test, Post Test 1 and Post Test 4
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: England Physical Therapy
state: California
city: Celebration
country: United States
facility: Florida Ear & Balance Center
state: Florida
city: Fort Myers
country: United States
facility: Stevenson & Associates Physical Therapy
state: Florida
city: Jacksonville
country: United States
facility: Brooks Balance Center
state: Florida
Study officials:
affiliation: BalanceSense LLC
name: Karen L Atkins, PhD, PT
role: STUDY_DIRECTOR
References: