Influence of Neuromodulation on Gait and Balance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Dynamic Gait Index
研究概览
简要总结
The purpose of this study is twofold:
- Establish baseline measures of gait performance in healthy young and older adults, and older adults with a history of falls.
- Investigate the effects of gait and balance training with and without cranial nerve noninvasive neuromodulation (CN-NINM) on postural balance and gait performance in older adults.
For the second purpose, the study will incorporate a placebo-controlled design to evaluate the effects of CN-NINM augmented exercise compared to physical exercises alone. Both groups will perform gait and postural balance training (outlined in more detail below) but will differ in the stimulation level of the PoNS device. The investigators will use the results of this study as a first step toward evaluating the benefits of CN-NINM in a falls prevention program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling
- •Able to understand and give informed consent
- •Able to stand and walk independently without an assistive device
- •No contraindication to exercise
- •Healthy young adults
- •Between ages of 18 and 39
- •Scores above 19 on Dynamic Gait Index
- •Healthy older adults without a history of falls
- •Scores above 19 on Dynamic Gait Index
- •Older adults with a history of falls
- •Self-reported history of 1-3 falls in previous year
- •Scores of 19 and below on the Dynamic Gait Index
排除标准
- •History of musculoskeletal disorders (lower-limb joint replacement, radiographic evidence of severe osteoarthritis, broken leg bone or ligament/tendon injury in prior 6 months)
- •Use of tobacco products
- •Any oral abrasions, cuts, cold sores, piercings, tissue inflammation, or have had oral surgery within the previous 3 months
- •Have a pacemaker or are identified as at-risk for cardiovascular events
- •Have a biomechanical prosthetic
- •If female, self-report of being pregnant
- •Neurological condition
- •Prisoners
- •Individuals clearly lacking the capacity to provide informed consent
研究组 & 干预措施
Young Adult - Control
Healthy subjects between the ages of 18-39 will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.
干预措施: Sham Cranial Nerve Non-Invasive Neuromodulation (Behavioral)
Young Adults - Intervention
Healthy subjects between the ages of 18-39 will participate in Cranial Nerve Non-Invasive Neuromodulation gait and balance training.
干预措施: Cranial Nerve Non-Invasive Neuromodulation (Device)
Healthy Older Adults - Control
Healthy subjects between age 65+ will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.
干预措施: Sham Cranial Nerve Non-Invasive Neuromodulation (Behavioral)
Healthy Older Adults - Intervention
Healthy subjects age 65+ will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training.
干预措施: Cranial Nerve Non-Invasive Neuromodulation (Device)
Older Fallers - Control
Subjects who are age 65+ with a history of 1-3 falls in the previous six months will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.
干预措施: Sham Cranial Nerve Non-Invasive Neuromodulation (Behavioral)
Older Fallers - Intervention
Subjects who are age 65+ with a history of 1-3 falls in the previous six months will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training.
干预措施: Cranial Nerve Non-Invasive Neuromodulation (Device)
结局指标
主要结局
Dynamic Gait Index
时间窗: Day 1 and approximately Day 12
An 8-item inventory of functional gait tasks each scored on a 0-3 point scale. Maximum score is 24 and any score of 19 or lower indicates an increased risk of falling.
次要结局
未报告次要终点