Modulating Brain Networks to Reduce Gait Variability in Older Adults at Risk of Falling
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Gait variability
研究概览
简要总结
Walking is a complex and continuous task that entails repetitive motions of the body. Relatively high gait variability sensitively predicts falls and cognitive decline in older adults. Previous work has identified an unique brain network relationship linked to gait variability and its relevant cognitive function (i.e., sustained attention). This project aims to develop a non-invasive brain stimulation montage designed to modulate the shared brain networks dynamics and to demonstrate its effects on resting state functional connectivity, gait and cognitive performance in older adults at risk for falls.
详细描述
This is a randomized controlled trial to examine the efficacy of a non-invasive brain stimulation intervention of tDCS to improve unsteady gait in older adults. The investigators will enroll 30 older adults with elevated gait variability. Participants will be randomized into one of two arms: a) 10 sessions of tDCS and b) 5 sessions of sham stimulation followed by 5 sessions of tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention - consisting of 10, once-daily, 20-min stimulation sessions over a 2-week period, and a set of post-intervention assessments. This project is expected to demonstrate that tDCS can be used to reduce gait variability in older adults.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 65 and above.
- •Ability to speak and read English.
- •Ability to walk independently and continuously for at least 1 minute.
- •Elevated gait variability as defined by a coefficient of variation (CoV) about average stride time larger and equal to 0.025 during straight-line walking at preferred speed.
排除标准
- •More than mild cognitive impairment defined by a Montreal Cognitive Assessment (MoCA) score less than
- •Parkinson's disease, multiple sclerosis, stroke, active brain tumor, or other neurological disorders.
- •Self-reported pain or lower extremity deformity that significantly disrupts walking.
- •Contraindications to MRI or tDCS.
- •An episode of acute illness or exacerbation of a diagnosis that requires hospitalization or active treatment within the past 3 months.
- •Current treatment for congestive heart failure, angina, uncontrolled arrythmia, deep vein thrombosis, or other uncontrolled cardiovascular events.
- •Myocardial infarction, coronary artery bypass grafting, angioplasty, or other cardiac conditions within the past 3 months,
- •Active cancer for which chemo/radiation therapy is being received.
- •Psychiatric co-morbidity including major depressive disorder, schizophrenia, psychosis, or other psychiatric illness.
- •Recent use of any sedating medications (sedatives, anti-psychotics, hypnotics, anti-depressants) or change in medication within the previous month.
- •Chronic vertigo or other diagnosed vestibular disorders.
- •Legal blindness, visual impairments that cannot be corrected with glasses, contact lenses, medicine, or surgery.
- •Those without WiFi access
- •Those who do not plan to live in their current homes for the duration of the study
结局指标
主要结局
Gait variability
时间窗: Baseline, Immediate post-intervention, 1 month follow up
This measure is captured by both Mobility Lab (APDM Inc) and the smart phone App. Gait variability is defined as the coefficient of variation to validated stride times.
次要结局
- Gait speed(Baseline, Immediate post-intervention, 1 month follow up)
- Accuracy (d prime) on the gradual onset continuous performance task (gradCPT)(Baseline, Immediate post-intervention, 1 month follow up)
- Dual-task gait performance(Baseline, Immediate post-intervention, 1 month follow up)