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N/A N=31 Randomized Treatment

Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation

Traumatic Brain Injury · Vestibular Deficits

Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Berg Balance Scale — 45; 44; 48; 47 Units on a continuous scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Sensory Kinetics Balance System (Device); Traditional Vestibular Rehabilitation (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Shirley Ryan AbilityLab
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Berg Balance Scale
45; 44; 48; 47; 50; 47
PRIMARY
Functional Gait Assessment (FGA)
15.714; 17.125; 18.929; 21.21; 20.642; 23.36
SECONDARY
10 Meter Walk Test
0.873; 1.067; 0.944; 1.236; 1.021; 1.253
SECONDARY
Six Minute Walk Test
1021.6; 1158.2; 1075.4; 1271.1; 1165.6; 1312.7
SECONDARY
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed
11.18375; 9.119280952; 15.98062479; 16.99357119; 17.986458; 20.423095
SECONDARY
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open
21.13041667; 21.13333333; 27.039375; 25.715; 27.467271; 26.277143
SECONDARY
Activities Balance Confidence Scale (ABC)
60.1396875; 55.53035714; 71.1828125; 60.11178571; 72.445313; 66.151786
SECONDARY
Dizziness Handicap Inventory
40.6; 40.5; 37.0; 38.5; 32.6; 26.0

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01672658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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