Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation

This study has been completed.
Sponsor:
Collaborators:
United States Department of Defense
Edward Hines Jr. VA Hospital
Information provided by (Responsible Party):
Arun Jayaraman, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01672658
First received: August 14, 2012
Last updated: March 3, 2016
Last verified: March 2016
  Purpose

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.

Condition Intervention
Traumatic Brain Injury
Vestibular Deficits
Device: Sensory Kinetics Balance System
Other: Traditional Vestibular Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Standard Vestibular Rehabilitation Training (VRT) vs. Sensory Kinetics Balance System (SKBS) + VRT on Balance and Functional Outcomes in the Mild Traumatic Brain Injury (mTBI) Population.

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Berg Balance Scale [ Time Frame: Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks) ] [ Designated as safety issue: Yes ]
    The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.

  • Functional Gait Assessment (FGA) [ Time Frame: Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks) ] [ Designated as safety issue: Yes ]

    Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect.

    10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment

    1. = moderate impairment
    2. = mild impairment
    3. = normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device


Secondary Outcome Measures:
  • 10 Meter Walk Test [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ] [ Designated as safety issue: No ]
    assesses walking speed of short duration

  • Six Minute Walk Test [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ] [ Designated as safety issue: No ]
    Assesses distance walked over 6 minutes

  • Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed [ Time Frame: Pre-training, mid training, post training ] [ Designated as safety issue: Yes ]

    Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges.

    The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.

    The scores of the 3 trials are averages


  • Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ] [ Designated as safety issue: Yes ]

    The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions.

    The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.

    The scores of the 3 trials are averages


  • Activities Balance Confidence Scale (ABC) [ Time Frame: Pre-training, mid training, post training ] [ Designated as safety issue: No ]

    Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.

    16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items


  • Dizziness Handicap Inventory [ Time Frame: Pre-training, mid training, post training ] [ Designated as safety issue: No ]

    A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness.

    Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)



Enrollment: 31
Study Start Date: January 2012
Study Completion Date: November 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sensory Kinectics Balance System
Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Device: Sensory Kinetics Balance System
Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.
Active Comparator: Traditional Vestibular Rehabilitation
Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Other: Traditional Vestibular Rehabilitation
Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672658

Locations
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rehabilitation Institute of Chicago
United States Department of Defense
Edward Hines Jr. VA Hospital
Investigators
Principal Investigator: Arun Jayaraman, PT, PhD Rehabilitation Institute of Chicago
  More Information

Responsible Party: Arun Jayaraman, Research Scientist, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01672658     History of Changes
Other Study ID Numbers: NUSTU58913 
Study First Received: August 14, 2012
Results First Received: May 22, 2015
Last Updated: March 3, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
TBI,
vestibular

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2016