Using Gait Robotics to Improve Symptoms of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Change in mood
研究概览
简要总结
This study evaluates the benefits of exoskeleton-based exercise for improving mood and cognition in people with Parkinson's disease (PD). Participants with PD will be assigned one of three treatments delivered over 8-weeks: exoskeleton exercise (experimental intervention), non-exoskeleton exercise (active comparator), and wait-list control (no treatment).
详细描述
Parkinson's Disease (PD) is a movement disorder that significantly impairs mobility and increases risk of falls. Many people with PD also experience mild cognitive impairment (MCI) and some progress to Parkinson's disease dementia (PDD). Non-pharmacologic treatments such as physical activity and exercise are known to be neuroprotective and may improve cognition, mood and overall functioning in PD, but such interventions can be challenging for individuals with PD and cognitive impairment to fully participate in. Robotic over-ground exoskeletons have the potential to overcome this barrier; however there are no scientific data yet to support the use robotic exoskeletons in the PD population or those with mood disorder and/or declining cognitive function.
This therapeutic exploratory trial will fill this gap in knowledge and provide critical data for understanding how to integrate exoskeletons into clinical practice for age-related movement disorders when cognitive decline is present. Specifically we will test if an 8-week functional exercise program (gait, balance, aerobic exercise) using the KEEOGO Rehab(tm) exoskeleton can improve mood and cognition, as well as gait and balance, compared to the same functional exercise without using the exoskeleton, and a wait-list control (no treatment).
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Cognitive function score >=16 on Montreal Cognitive Assessment (MoCA)
- •Diagnosed with Parkinson's disease, Hoehn and Yahr stage 1 to 4
- •Able to walk 10 meters without stopping and without human assistance (using assistive devices such as cane or walker if normally used)
- •Waist and leg circumference and lower extremity lengths appropriate for a comfortable and safe fit in the KEEOGO device
排除标准
- •Legally blind
- •Treatment with another investigational drug or other intervention within the study period
- •New medications started within last 4 weeks
- •Skin condition that contraindicates use of orthotics or support braces
- •Lower-extremity amputation above or below the knee
- •Uncontrolled orthostatic hypotension
- •Psychiatric disorders such as schizophrenia or bipolar disorder
- •Other diagnosis that impairs gait and balance, such as, but not limited to, chronic obstructive pulmonary disease; peripheral arterial disease; vestibular disorders; cerebellar disease; cerebral palsy; muscular dystrophy; spinal cord injury; stroke or other brain injury; severe degenerative joint disease (osteoarthritis, rheumatoid arthritis, etc.)
结局指标
主要结局
Change in mood
时间窗: Baseline and 8 weeks
14-item "Hospital Anxiety and Depression Scale" (HADS) instrument to measure mood disorder; Total score, range 0-42, higher scores = more severe mood disorder
Change in cognitive function
时间窗: Baseline and 8 weeks
10-item "Scales for Outcomes in Parkinson's-Cognition" (SCOPA-COG) instrument to evaluate cognitive function; Total score, range 0-43, higher scores = better cognitive functioning.
次要结局
- Change in UPDRS Mentation score(Baseline and 8 weeks)
- Change in self-report balance confidence (of not falling)(Baseline and 8 weeks)
- Change in gait speed(Baseline and 8 weeks)
- Change in UPDRS Motor score(Baseline and 8 weeks)
- Change in functional balance(Baseline and 8 weeks)
- Change in dual-task gait cost index(Baseline and 8 weeks)
- Change in dual-task cognitive cost index(Baseline and 8 weeks)
- Change in six minute walk test score(Baseline and 8 weeks)
研究者
Chris A. McGibbon, PhD
Professor, Faculty of Kinesiology
University of New Brunswick