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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Berg Balance Scale
研究概览
简要总结
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.
- Hypotheses & Research Objectives and Purpose:
The specific research questions to be addressed are:
- 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.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sensory Kinetics Balance System (Device)
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.
干预措施: Traditional Vestibular Rehabilitation (Other)
结局指标
主要结局
Berg Balance Scale
时间窗: 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)
时间窗: 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
次要结局
- 10 Meter Walk Test(Pre-training, mid training (4 weeks), post training (8 weeks))
- Six Minute Walk Test(Pre-training, mid training (4 weeks), post training (8 weeks))
- Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed(Pre-training, mid training, post training)
- Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open(Pre-training, mid training (4 weeks), post training (8 weeks))
- Activities Balance Confidence Scale (ABC)(Pre-training, mid training, post training)
- Dizziness Handicap Inventory(Pre-training, mid training, post training)
研究者
Arun Jayaraman
Research Scientist
Shirley Ryan AbilityLab