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Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation

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ClinicalTrials.gov Identifier: NCT01672658
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Collaborators:
United States Department of Defense
Edward Hines Jr. VA Hospital
Information provided by (Responsible Party):
Arun Jayaraman, Shirley Ryan AbilityLab

Tracking Information
First Submitted Date  ICMJE August 14, 2012
First Posted Date  ICMJE August 27, 2012
Results First Submitted Date  ICMJE May 22, 2015
Results First Posted Date  ICMJE April 4, 2016
Last Update Posted Date April 4, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
  • Berg Balance Scale [ Time Frame: Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks) ]
    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) ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2012)
  • Berg Balance Scale [ Time Frame: Pre-training,change from baseline to mid training (4 weeks), change from bseline to post training (8 weeks) ]
    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) ]
    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) ]
    Assesses balance under a variety of conditions including vision blocked and surface challenges.
Change History Complete list of historical versions of study NCT01672658 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
  • 10 Meter Walk Test [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ]
    assesses walking speed of short duration
  • Six Minute Walk Test [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ]
    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 ]
    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) ]
    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 ]
    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 ]
    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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2012)
  • 10 Meter Walk Test [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ]
    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) ]
    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) ]
    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) ]
    Assesses distance walked over 6 minutes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation
Official Title  ICMJE 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.
Brief 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.
Detailed Description

Traumatic brain injury (TBI) occurs when physical trauma causes temporary or permanent neurological damage. In some cases, symptoms can continue over time and contribute to disability. Dizziness and vertigo are associated with nearly all reported studies of mild Traumatic Brain Injury (mTBI) and are a significant and functionally limiting component of the overall disability.

TBI is one of the many risks faced by military personnel in combat activities . In a RAND Corporation survey of service members who had been deployed to Iraq or Afghanistan, 19% reported probable TBI. Dizziness and vertigo are associated with nearly all reported studies of mTBI and are a significant and debilitating component of the overall disability. mTBI are currently caused by both blast and impact injuries resulting in variable disabilities . Overt symptoms may include balance and spatial disorientation problems (vertigo) related to vestibular dysfunction, vision disturbances, inner-ear edema, and/or other sensory integration deficits.

Treatment of this particular population group has several challenges which include: 1) difficulty with early and specific injury assessment 2) the determination of appropriate return-to-duty measures 3) selection of effective individualized balance rehabilitation and treatment tools 4) Prolonged length of rehabilitation and uncertain measureable endpoints. The group is also highly variable in the nature and extent of balance deficits and cognitive and / or related psychological impairments. It appears that almost all subjects with mTBI show some susceptibility to vestibular or vestibular/ocular disorders.

After assessment of disequilibrium, rehabilitation is often a course of remedial physical therapy (PT). To affect change in mobility by standard physical therapy, sensory and motor systems are "habituated" through exercise, with hope of rehabilitating the system and "compensating" by instructing the patient to alter skill sets associated with a task. Compensation (without immediate sensory feedback) is problematic and prone to patient (and caregiver) interpretation and error, because it may not address the underlying problems and may not have long term therapeutic benefits. There is also a very limited pool of PTs who specialize in the treatment of neurological problems resulting from brain injuries. Individual vestibular rehabilitation treatment programs are designed by these specialist PTs who also monitor and participate in each patient's recovery. This approach is labor intensive, time consuming (up to 14 weeks of therapy is often needed) and some patients do not recover fully .

The overall objective of this research effort is to use novel combinations of multi-modal sensory guided feedback (especially tactile) and traditional vestibular rehabilitation to retrain military personnel suffering balance disorders as a result of mTBI. The investigators therapeutic goal is to test technology that will return the patient, in the shortest period of time, to a level of balance performance consistent with return to the community and/or military duty.

The sense of touch is intrinsically linked with the neuro-motor channel, both at the reflex and higher cognitive regions, which makes it uniquely tied to orientation and localization. Vibrotactile arrays are therefore intuitive and are an effective sensory feedback pathway.

Recent research has also demonstrated that tactile cueing yield significantly faster and more accurate performance than comparable spatial auditory cues. Further research has demonstrated this finding is relatively stable across a variety of body orientations, even when spatial translation is required and under physiological stress.

Over a Phase I SBIR and current Phase II effort, Engineering Acoustics Inc. has developed the Sensory Kinetics (SK) Balance System. In the SK system, patients move on a force platform (see Figure 1) while movement and posture data is interpreted by advanced software a mapped to a wearable vibrotactile belt array and visual display. Vibrotactile cueing provides continuous and instantaneous feedback to the patient that compliments their postural and mobility decisions. The investigators believe that vibrotactile feedback can greatly increase spatial awareness and consequently mobility. Further, the ability of the brain to re-organize and relearn functional movement activities provides an intriguing potential pathway for the retention of learned functional mobility strategies.Vibrotactile cueing involves short duration bursts of mechanical vibration from actuators, or tactors, that are mounted within a torso worn belt. The person's position is measured and calculated using a force plate sensor and camera sensors. The computerized system is then used as part of physical therapy balance training to improve the patient's balance and potentially reduce their risk of falling.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Vestibular Deficits
Intervention  ICMJE
  • Device: Sensory Kinetics Balance System
    Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.
  • Other: Traditional Vestibular Rehabilitation
    Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Sensory Kinetics Balance System
  • 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.
    Intervention: Other: Traditional Vestibular Rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2016)
31
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2012)
40
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01672658
Other Study ID Numbers  ICMJE NUSTU58913
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arun Jayaraman, Shirley Ryan AbilityLab
Study Sponsor  ICMJE Shirley Ryan AbilityLab
Collaborators  ICMJE
  • United States Department of Defense
  • Edward Hines Jr. VA Hospital
Investigators  ICMJE
Principal Investigator: Arun Jayaraman, PT, PhD Shirley Ryan AbilityLab
PRS Account Shirley Ryan AbilityLab
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP