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Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01672658
Enrollment
31
Registered
2012-08-27
Start date
2012-01-31
Completion date
2014-11-30
Last updated
2016-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury, Vestibular Deficits

Keywords

TBI,, vestibular

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.

Interventions

DEVICESensory Kinetics Balance System

Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.

Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.

Sponsors

United States Department of Defense
CollaboratorFED
Edward Hines Jr. VA Hospital
CollaboratorFED
Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Berg Balance ScalePre-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)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

Secondary

MeasureTime frameDescription
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes ClosedPre-training, mid training, post trainingClinical 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 OpenPre-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
10 Meter Walk TestPre-training, mid training (4 weeks), post training (8 weeks)assesses walking speed of short duration
Dizziness Handicap InventoryPre-training, mid training, post trainingA 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)
Activities Balance Confidence Scale (ABC)Pre-training, mid training, post trainingSubjective 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
Six Minute Walk TestPre-training, mid training (4 weeks), post training (8 weeks)Assesses distance walked over 6 minutes

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.
16
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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
14
Total30

Baseline characteristics

CharacteristicTraditional Vestibular RehabilitationSensory Kinectics Balance SystemTotal
Age, Categorical
<=18 years
0 Participants1 Participants1 Participants
Age, Categorical
>=65 years
0 Participants2 Participants2 Participants
Age, Categorical
Between 18 and 65 years
14 Participants13 Participants27 Participants
Age, Continuous41.9 years
STANDARD_DEVIATION 9.6
42.5 years
STANDARD_DEVIATION 16.4
42.2 years
STANDARD_DEVIATION 13.5
Region of Enrollment
United States
14 participants16 participants30 participants
Sex: Female, Male
Female
6 Participants5 Participants11 Participants
Sex: Female, Male
Male
8 Participants11 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 160 / 14
serious
Total, serious adverse events
0 / 160 / 14

Outcome results

Primary

Berg Balance Scale

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.

Time frame: Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Sensory Kinectics Balance SystemBerg Balance ScalePre training45 Units on a continuous scaleStandard Deviation 10.94969558
Sensory Kinectics Balance SystemBerg Balance ScaleMid Training48 Units on a continuous scaleStandard Deviation 10.83743512
Sensory Kinectics Balance SystemBerg Balance ScalePost Training50 Units on a continuous scaleStandard Deviation 8.932851355
Traditional Vestibular RehabilitationBerg Balance ScalePre training44 Units on a continuous scaleStandard Deviation 10.65338
Traditional Vestibular RehabilitationBerg Balance ScaleMid Training47 Units on a continuous scaleStandard Deviation 10.27212167
Traditional Vestibular RehabilitationBerg Balance ScalePost Training47 Units on a continuous scaleStandard Deviation 11.25649995
Primary

Functional Gait Assessment (FGA)

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

Time frame: Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Sensory Kinectics Balance SystemFunctional Gait Assessment (FGA)Pre-training15.714 units on a scaleStandard Deviation 6.51
Sensory Kinectics Balance SystemFunctional Gait Assessment (FGA)Mid-training assessment (4 weeks)18.929 units on a scaleStandard Deviation 6.52
Sensory Kinectics Balance SystemFunctional Gait Assessment (FGA)Post-training (8 weeks)20.642 units on a scaleStandard Deviation 6.52
Traditional Vestibular RehabilitationFunctional Gait Assessment (FGA)Pre-training17.125 units on a scaleStandard Deviation 5.72
Traditional Vestibular RehabilitationFunctional Gait Assessment (FGA)Mid-training assessment (4 weeks)21.21 units on a scaleStandard Deviation 6.65
Traditional Vestibular RehabilitationFunctional Gait Assessment (FGA)Post-training (8 weeks)23.36 units on a scaleStandard Deviation 6.87
Secondary

10 Meter Walk Test

assesses walking speed of short duration

Time frame: Pre-training, mid training (4 weeks), post training (8 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Sensory Kinectics Balance System10 Meter Walk TestPre-training0.873 m/sStandard Deviation 0.496
Sensory Kinectics Balance System10 Meter Walk TestMid-training assessment (4 weeks)0.944 m/sStandard Deviation 0.617
Sensory Kinectics Balance System10 Meter Walk TestPost-training (8 weeks)1.021 m/sStandard Deviation 0.652
Traditional Vestibular Rehabilitation10 Meter Walk TestPre-training1.067 m/sStandard Deviation 0.532
Traditional Vestibular Rehabilitation10 Meter Walk TestMid-training assessment (4 weeks)1.236 m/sStandard Deviation 0.632
Traditional Vestibular Rehabilitation10 Meter Walk TestPost-training (8 weeks)1.253 m/sStandard Deviation 0.749
Secondary

Activities Balance Confidence Scale (ABC)

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

Time frame: Pre-training, mid training, post training

ArmMeasureGroupValue (MEAN)Dispersion
Sensory Kinectics Balance SystemActivities Balance Confidence Scale (ABC)Pre-training60.1396875 units on a scaleStandard Deviation 23.04021958
Sensory Kinectics Balance SystemActivities Balance Confidence Scale (ABC)Mid Training71.1828125 units on a scaleStandard Deviation 21.01544763
Sensory Kinectics Balance SystemActivities Balance Confidence Scale (ABC)Post Training72.445313 units on a scaleStandard Deviation 22.50808738
Traditional Vestibular RehabilitationActivities Balance Confidence Scale (ABC)Pre-training55.53035714 units on a scaleStandard Deviation 23.85675041
Traditional Vestibular RehabilitationActivities Balance Confidence Scale (ABC)Mid Training60.11178571 units on a scaleStandard Deviation 20.51856435
Traditional Vestibular RehabilitationActivities Balance Confidence Scale (ABC)Post Training66.151786 units on a scaleStandard Deviation 19.0398228
Secondary

Dizziness Handicap Inventory

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)

Time frame: Pre-training, mid training, post training

Population: This data includes the participants in this study that self reported yes to dizziness. If they answered no to dizziness they did not have the scale administered to them.

ArmMeasureGroupValue (MEAN)Dispersion
Sensory Kinectics Balance SystemDizziness Handicap InventoryPre-training40.6 Units on a scaleStandard Deviation 26.87
Sensory Kinectics Balance SystemDizziness Handicap InventoryMid Training37.0 Units on a scaleStandard Deviation 28.41
Sensory Kinectics Balance SystemDizziness Handicap InventoryPost Training32.6 Units on a scaleStandard Deviation 25.58
Traditional Vestibular RehabilitationDizziness Handicap InventoryPre-training40.5 Units on a scaleStandard Deviation 10.88
Traditional Vestibular RehabilitationDizziness Handicap InventoryMid Training38.5 Units on a scaleStandard Deviation 11.47
Traditional Vestibular RehabilitationDizziness Handicap InventoryPost Training26.0 Units on a scaleStandard Deviation 9.09
Secondary

Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed

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

Time frame: Pre-training, mid training, post training

ArmMeasureGroupValue (MEAN)Dispersion
Sensory Kinectics Balance SystemModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes ClosedPost Training17.986458 secStandard Deviation 11.13131861
Sensory Kinectics Balance SystemModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes ClosedPre-Training11.18375 secStandard Deviation 10.15539992
Sensory Kinectics Balance SystemModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes ClosedMid Training15.98062479 secStandard Deviation 12.19808074
Traditional Vestibular RehabilitationModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes ClosedPre-Training9.119280952 secStandard Deviation 7.06647348
Traditional Vestibular RehabilitationModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes ClosedMid Training16.99357119 secStandard Deviation 11.85259485
Traditional Vestibular RehabilitationModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes ClosedPost Training20.423095 secStandard Deviation 9.057258643
Secondary

Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open

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

Time frame: Pre-training, mid training (4 weeks), post training (8 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Sensory Kinectics Balance SystemModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes OpenPre-training21.13041667 secStandard Deviation 10.59997686
Sensory Kinectics Balance SystemModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes OpenMid Training27.039375 secStandard Deviation 10.71693518
Sensory Kinectics Balance SystemModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes OpenPost Training27.467271 secStandard Deviation 9.635670393
Traditional Vestibular RehabilitationModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes OpenPre-training21.13333333 secStandard Deviation 10.93591753
Traditional Vestibular RehabilitationModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes OpenMid Training25.715 secStandard Deviation 9.43461609
Traditional Vestibular RehabilitationModified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes OpenPost Training26.277143 secStandard Deviation 9.195793711
Secondary

Six Minute Walk Test

Assesses distance walked over 6 minutes

Time frame: Pre-training, mid training (4 weeks), post training (8 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Sensory Kinectics Balance SystemSix Minute Walk TestPre-training1021.6 FeetStandard Deviation 544.1
Sensory Kinectics Balance SystemSix Minute Walk TestMid-training assessment (4 weeks)1075.4 FeetStandard Deviation 624.1
Sensory Kinectics Balance SystemSix Minute Walk TestPost-training (8 weeks)1165.6 FeetStandard Deviation 662.1
Traditional Vestibular RehabilitationSix Minute Walk TestPre-training1158.2 FeetStandard Deviation 490.5
Traditional Vestibular RehabilitationSix Minute Walk TestMid-training assessment (4 weeks)1271.1 FeetStandard Deviation 566.1
Traditional Vestibular RehabilitationSix Minute Walk TestPost-training (8 weeks)1312.7 FeetStandard Deviation 627.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026