Cognitive Integrated Motor Training to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 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 in older adults with mild cognitive impairment. 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)/mixed reality (MR) 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 in older adults with mild cognitive impairment.
The study will evaluate the differences between two intervention groups (n=20 each): 1) personalized cognitive integrated sensorimotor VR/MR training (CM), and 3) standard of care (CTRL) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CM.
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the age of 65 and 85 years for older adults.
- •Montreal Cognitive Assessment (MOCA), 17 < MOCA < 24
- •Medical clearance will be obtained from my clinician. If participants physician is unavailable the study team clinician will provide the medical clearance.
- •Adequate cognitive function to give informed consent, understand the training and instructions, use the device and give adequate feedback.
- •Able to stand for 5 minutes.
排除标准
- •Body weight over 135 kgs.
- •Uncontrolled or unstable seizure disorder.
- •Severe joint contracture or spasticity of the ankle that limits passive range of motion as determined by the team.
- •History of severe cardiac diseases such as myocardial infarction, coronary artery disease, cardiac arrhythmia, or congestive heart failure.
- •Neuromuscular or neurological pathologies (e.g., spinal cord injury, stroke) that will interfere with ambulation.
- •Uncontrolled or unstable orthostatic hypotension.
- •Pre-existing conditions resulting in significant disruption in alignment or function of the lower limb during standing.
- •History of injury or pathology to the lower limbs in the past 6 months or any medical issue precludes full weight-bearing and ambulation (e.g., orthopedic injuries).
- •Diplopia or nystagmus.
- •Walking speed from 10MWT >0.8m/s.
- •MRI specific exclusion criteria:
- •Medications such as: steroids, benzodiazepines, and neuroleptics. The study doctor will review the medications with the participant.
- •clip to repair a cerebral aneurysm (broken blood vessel in the head), cardiac pace-maker, cochlear implants (internal hearing aids) or metal fragments or pieces in the eyes or any other part of the body.
- •non MRI compatible metal in any part of the body.
- •Medical clearance from a physician that it is medically unsafe to receive regular MRI.
- •Engage in the professions of painting or welding or other occupation that prevents me from getting a regular MRI.
- •claustrophobia (fear of enclosed spaces).
- •History of schizophrenia or bipolar disorder.
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.
Temporal characteristics
时间窗: 10 weeks
This test assesses deviations in timing of steps during walking.
Symbol Digit Modalities Test (SDMT)
时间窗: 10 weeks
This test assesses processing speed without a motor component
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.
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.
Balance
时间窗: 10 weeks
Root-mean-square of COM and COP displacements will be used to quantify balance tasks. COP will be obtained from Hunova. Whole body COM will be obtained using motion capture.
Spatial characteristics
时间窗: 10 weeks
This test assesses deviations in steplength during walking.
Physiological
时间窗: 10 weeks
The participants will wear small sensors on their body to assess the activity of the brain and muscles during walking and balancing tasks.
Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])
时间窗: 10 weeks
This test assesses attention and working memory.
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.
Paced Auditory Serial Addition Test (PASAT)
时间窗: 10 weeks
This test assesses information processing speed \& ability and working memory
Letter-Number Sequencing (WAIS-IV)
时间窗: 10 weeks
This test assesses working memory
Delis-Kaplan Executive Function System
时间窗: 10 weeks
Selected subtests to assess executive function.
Community Ambulation
时间窗: 10 weeks
This test quantifies the amount of physical activity in the community using IMU sensors that participants will wear.
Continuous Performance Task
时间窗: 10 weeks
This test assesses attention.
Magnetic Resonance Imaging (MRI)
时间窗: 1 week
MRI scans will be performed to assess the structure and function of the brain while the participant is lying quietly in the MRI scanner.
次要结局
- 6 Minute Walk Test(10 weeks)
- Dynamic Gait Index (DGI)(10 weeks)
研究者
Kiran Karunakaran
Research Scientist, Principal Investigator
Kessler Foundation