Use of a Robotic Walking Device to Improve Home and Community Mobility in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Gait Velocity
研究概览
简要总结
This Phase II randomized controlled trial proposes to examine the impact of long-term use of a novel light-weight and wearable assistive robotic device, called the Honda Walking Assist (HWA) device, to improve mobility in the home and community in individuals with mild to moderate Parkinson's disease (PD). Specific aims of the project are to: 1) determine the short-term impact of mechanical gait assistance on efficiency and ease of walking in individuals with PD, and 2) determine the effect of long-term HWA device usage on the ease and ability to walk unassisted in the home and community in individuals with PD.
详细描述
Difficulties with walking in people with Parkinson's disease contribute to injurious falls and decreased quality of life. The Honda Walking Assist (HWA) robotic device is designed to assist individuals with gait impairments to take longer strides and walk faster. This study will investigate the impact of HWA usage on mobility in the home and community in individuals with PD. It will also examine feasibility and safety of HWA usage in the PD population. Specific Aim 1: Determine the short-term impact of mechanical gait assistance on efficiency and ease of walking in individuals with PD. With disease progression, individuals with PD develop gait impairments (e.g., slower gait velocity, shorter step lengths, increased step-to-step variability, and freezing of gait), that interfere with their abilities to perform daily living tasks and participate in work, home, and social activities and predispose them to falls. The investigators hypothesize that wearing the HWA device will improve gait efficiency, gait parameters, and perceived ease of walking in individuals with PD compared to unassisted walking over a one session period. Specific Aim 2: Determine the effect of long-term HWA device usage on the ease and ability to walk unassisted in the home and community in individuals with PD. Angular sensors embedded in the HWA monitor the cadence, angular velocity, and degree of hip extension and flexion of the device user. When the user initiates walking, the HWA automatically adjusts leg movements to reach target walk ratios (step length/cadence) by increasing the amount of hip flexion and/or extension using power supplied by the device. Thus, the HWA applies continuous, step-by-step cueing to individuals with PD to take bigger and more symmetrical steps, thereby producing a faster and more efficient walking pattern. By wearing the HWA device over an extended period of time, individuals with PD will repetitively practice walking with a more "normal" gait pattern, possibly driving neuroplastic changes that will translate to improve unassisted walking. The investigators hypothesize that an 8-week intervention of HWA device usage will improve gait efficiency, gait parameters, perceived ease of walking, self-confidence, and daily physical activity in the home and community in individuals with PD with and without the use of the device.
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)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease
- •Age 50-80 years
- •Able to ambulate without assistance (Hoehn & Yahr stages 1-3)
- •On stable doses of Parkinson's medications for at least 4 weeks prior to the study.
排除标准
- •Presence of other significant cardiac, neurological or orthopedic problems that affect gait
- •Weight more than 220 pounds and height greater than 6'8"
- •Electronic medical devices embedded in the body
- •Participating in any physical therapy
- •Inability to understand instructions required by the study.
结局指标
主要结局
Gait Velocity
时间窗: 8 weeks
Walking speed in meters per second
次要结局
- Swing Time - Right Leg(8 weeks)
- Self-Efficacy for Measuring Chronic Disease 6-Item Scale(8 weeks)
- Stride Length(8 weeks)
- Swing Time Coefficient of Variation of Left Leg(8 weeks)
- Stride Length Coefficient of Variation(8 weeks)
- 6-Minute Walk Test(8 weeks)
- Swing Time - Left Leg(8 weeks)
- Double Support Time Coefficient of Variation(8 weeks)
- Swing Time Coefficient of Variation of Right Leg(8 weeks)
- Participants' Perceived Ease of Walking(8 weeks)
- Double Support Time(8 weeks)
- Freezing of Gait Questionnaire(8 weeks)
- Number of Participants With Falls(8 weeks)
研究者
Anne Kloos
Professor-Clinical
Ohio State University