Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance in People with Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Timed Up and Go (TUG)
研究概览
简要总结
Problems with walking and balance are common after traumatic brain injury (TBI). Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/augmented reality (AR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training after a brain injury.
The study will evaluate the differences between three intervention groups (n=45 each): 1) personalized cognitive integrated sensorimotor VR/AR training (CMT), 2) traditional dual-task training (CTRL), and 3) standard of care (SOC) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CMT.
详细描述
Traumatic brain injury (TBI) affects 2.87 million people annually in the US and is a leading cause of long-term disability. TBI impairs both cognitive and sensorimotor functions, with debilitating consequences on ambulation (gait & balance), which persist during the chronic stages of recovery. Individuals with TBI-induced gait & balance dysfunction are at a higher risk of falls leading to another TBI. Gait & balance control is a complex interplay between various cognitive and motor processes, and disruption of any of these processes can severely affect gait & balance and result in falls. Research examining TBI-related changes in cognitive demands associated with gait & balance control has shown increased cognitive demand to perform gait & balance tasks in individuals with TBI, with increases in cognitive demand for more complex tasks. This strong link between cognitive (attention, processing speed & executive function) and sensorimotor functions is the basis for the proposed project. The investigators aim to strengthen this inseparable link using a novel cognitive-motor intervention.
The investigators propose a training regimen, cognitive integrated sensorimotor training (CMT), which increases the cognitive-motor effort to perform the tasks. CMT uses virtual and augmented reality (VR/AR) to employ the cognitive system to perform the motor task in order to train the inseparable cognitive and motor components that are critically important for gait & balance function. Here the cognitive task is "incorporated" into the motor task, as the cognitive task is a relevant prerequisite for successfully completing the sensorimotor task. The investigators hypothesize that CMT will maximize gait & balance function and reduce falls in adults with TBI.
The study will evaluate the differences between three intervention groups (n=45 each): a) personalized cognitive integrated sensorimotor VR/AR training (CMT), b) traditional dual-task training (CTRL), and c) standard of care (SOC) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CMT.
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
- Single (Outcomes Assessor)
盲法说明
Single-blind randomized clinical trial
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 18-65 years of age.
- •Be a person living with TBI for at least 6 months.
- •Be able to follow directions and commands.
- •Be able to speak and understand English well as evaluated by a test I will be given by the researchers.
- •Not have amnesia (as determined by study staff based on a Post Traumatic Amnesia O-log score of > 20 on 2 consecutive days)
- •Have approval from a physician to participate.
- •Have no history of injury or problems with my legs in the past 6 months or any medical issue which would interfere with my ability to bear weight on my legs and walk (such as a bone or muscle injury).
- •No double vision (diplopia) or other vision problems (such as nystagmus, as determined by study staff)
- •Have joint passive range of motion within normal functional limits for walking as determined by study staff.
- •Have a walking speed of less than 0.8 m/s as determined by study staff.
- •Be able to stand for 5 minutes.
排除标准
- •I have uncontrolled or unstable seizure disorder (such as epilepsy).
- •I have pre-existing condition that makes it difficult for me to exercise (such as diagnosed high blood pressure that is not controlled, heart disease, irregular heart rate or rhythm, or congestive heart failure).
- •I have muscle or nervous system problems other than TBI (such as spinal cord injury, multiple sclerosis, or Parkinson's disease)
- •Have any joint or muscle tightness that would limit my movement while walking.
- •I have any medical issue that prevents me from supporting my weight (such as bone or muscle injuries, pain, or severe muscle spasms).
- •I have been diagnosed with cognitive (thinking) problems prior to TBI.
- •I have severe dizziness (Dizziness Handicap Inventory score greater than 54 (as measured by study staff).
- •I have skin issues that would prevent me from wearing a safety harness.
结局指标
主要结局
Timed Up and Go (TUG)
时间窗: 10 weeks
TUG is a clinical test of functional gait abilities and dynamic balance. The participants will be asked to walk a distance of 3 meters from a seated position, turn around, walk back to the chair and sit back in the chair. The time taken to perform the task will be recorded using a stop watch. The TUG will be repeated multiple times. The participant may be asked to hold a plastic cup or count backwards by three from a randomly selected number while walking.
10 Meter walk test
时间窗: 10 weeks
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Berg balance Assessment:
时间窗: 10 weeks
This is a test that measures balance on a 5-point during routine tasks. The participant will be asked to perform 14 tasks involving: sitting, standing, reaching, lifting, and turning.
Paced Auditory Serial Addition Test (PASAT)
时间窗: 10 weeks
This test assesses information processing speed \& ability and working memory
Hopkins Verbal Learning Test Revised
时间窗: 10 weeks
This test assesses acquisition and delayed recall of verbal information.
Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])
时间窗: 10 weeks
This test assesses attention and working memory.
Letter-Number Sequencing (WAIS-IV)
时间窗: 10 weeks
This test assesses working memory
Fall Risk
时间窗: 10 weeks
The silver index will be measured using the Hunova (Movendo Srl., Italy) to quantify the risk of falls. The Silver Index tasks include static balance while eyes are open or closed, dynamic balance while standing on passive and elastic surfaces, limits of stability, reactive balance during perturbations, 6-meter walk, and sit-to-stand.
Participation Objective, Participation Subjective (POPS)
时间窗: 10 weeks
POPS assesses perspectives of the respondent regarding participation in home \& community, and societal/normative ("outsider") evaluation. POPS consists of 26 items sorted into 5 categories \[a) Domestic Life, b) Major Life Activities, c) Transportation, d) Interpersonal Interactions and Relationships, e) Community, Recreational and Civic Life\].
Flanker Inhibitory Control and Attention Test
时间窗: 10 weeks
This test assesses the allocation of limited attentional capacities to deal with an abundance of environmental stimulation. The test measures attention and the ability to inhibit response that may interfere with the ability to achieve goals.
Neurophysiological- Maximum increase in O2Hb concentration in cortical regions
时间窗: 10 weeks
The change in the hemoglobin concentration in response to a metabolic event (neuronal) such as walking is known as the hemodynamic response (HDR) of the brain. The maximum increase following a task will be quantified as net cortical responsivity to task using functional near infrared spectroscopy (fNIRS)
Delis-Kaplan Executive Function System
时间窗: 10 weeks
Selected subtests to assess executive function.
Quality of Life after Brain Injury (QOLIBRI)
时间窗: 10 weeks
This assesses QoL in people with TBI and is a 37-item scale with six subscales. The first part assesses "satisfaction level" with Health-related Quality of Life (HRQOL) and is composed of 6 overall items and 29 items assigned to 4 subscales: a) thinking, b) feelings and emotion, c) autonomy in daily life, and d) social aspects. The second part is devoted to "bothered" questions and composed of 12 items in 2 subscales: a) negative feelings, and b) restrictions. Responses to the 'satisfaction' items are coded on a 1 to 5 scale, where 1= "not at all satisfied" and 5= "very satisfied". Responses to the 'bothered' items are reverse scored to correspond with the satisfaction items, where 1=" very bothered" and 5= "not at all bothered".
Symbol Digit Modalities Test (SDMT)
时间窗: 10 weeks
This test assesses processing speed without a motor component
Temporal and spatial characteristics
时间窗: 10 weeks
This test assess gait deviations and symmetry
Balance
时间窗: 10 weeks
Root-mean-square of COM and COP displacements will be used to quantify static and dynamic balance during Silver Index tasks. COP will be obtained from Hunova. Whole body COM will be obtained using motion capture.
次要结局
- minimum change in O2Hb(10 weeks)
- Community Integration Questionnaire (CIT)(10 weeks)
- Dynamic Gait Index (DGI)(10 weeks)
- Walking While Talking Test(10 weeks)
- functional connectivity(10 weeks)
- 6 Minute Walk Test(10 weeks)
- Area under the curve (AOC)(10 weeks)
- Electromyography(10 weeks)
- Patient Competency Rating Scale (PCRS)(10 weeks)