Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation
Completed · Not applicable
Conditions studied: Traumatic Brain Injury, Vestibular Deficits
In brief
The goal of this clinical research study at RIC is to determine the value and benefit of the SK multimodal balance training system through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in balance and functional assessments. This study is primarily funded through Engineering Acoustics as a subcontract for a phase II Small Business Innovation Research by the Department of Defense. 3\) Hypotheses \& Research Objectives and Purpose: The specific research questions to be addressed are: 1. How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT intervention on balance and functional gait measures in mild traumatic brain injury (mTBI) participants. 2. How do SKBS measurement tools compare to standard clinical assessments of gait and balance in mTBI patients The purpose of this clinical research study is to compare the value and benefit of the SK multimodal balance training system in combination with traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in clinical measures of balance, functional mobility, and gait assessment.
Key facts
- Study ID
- NCT01672658
- Run by
- Shirley Ryan AbilityLab
- People needed
- 31
- Starts
- 2012-01-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2016-04-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Mild to moderate Traumatic Brain Injury
- Adults 18 years-75 years old
- Vestibular \&/or balance deficit following mild/moderate TBI and confirmed by healthcare professional
- Subjects reporting head injury from exposure to a blast/concussion injury with one or more of the following symptoms: dizziness, vertigo, headache, migraine, oscillopsia, movement induced vertigo.
- Able to sit unaided for two minutes
- Able to stand independently with or without a cane, or with no more than moderate assistance from the physical therapist/researcher.
You may not qualify if…
- Multiple trauma
- Severe brain injury as defined above
- Pacemakers
- Weight greater than 250 lbs
- Mini Mental Status Exam score of less than 24 and/or Cognitive Log score of less than 25
- A diagnosis of:
- Peripheral neuropathy
- Severe neuromuscular diseases
- Severe Cardiovascular disease
- Associated high-level stroke or spinal cord injury
- Amputees
Where it is running
- Rehabilitation Institute of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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