Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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: July 7, 2014
Last verified: July 2014
  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,change from baseline to mid training (4 weeks), change from bseline to post training (8 weeks) ] [ Designated as safety issue: Yes ]
    14 item measure designed to assess static balance and fall risk.

  • Functional Gait Assessment (FGA) [ Time Frame: pre-training,change from baseline to mid-training (4 weeks), change from baseline to post-training (8weeks) ] [ Designated as safety issue: Yes ]
    Assesses postural stability during walking tasks.

  • Modified Clinical Test of Sensory Interaction and Balance (CTSIB) [ Time Frame: pre-training, change from baseline to mid-training (4 weeks) and change from baseline to post-training (8 weeks) ] [ Designated as safety issue: Yes ]
    Assesses balance under a variety of conditions including vision blocked and surface challenges.


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

  • Activities-specific and Balance Confidence Scale (ABC): [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ] [ Designated as safety issue: No ]
    Subjective measure of confidence in performing various ambulatory activities without falling

  • Dizziness Handicap Inventory [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ] [ Designated as safety issue: No ]
    if dizziness is present: assesses the degree of disability associated with any cause of dizziness.

  • 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


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
Edward Hines Jr. VA Hospital
Investigators
Principal Investigator: Arun Jayaraman, PT, PhD Rehabilitation Institute of Chicago
  More Information

No publications provided

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
Last Updated: July 7, 2014
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
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 01, 2014