Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation
Status: | Completed |
---|---|
Conditions: | Hospital, Neurology |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/21/2016 |
Start Date: | January 2012 |
End Date: | November 2014 |
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.
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.
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.
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.
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.
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
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