Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Safety of the Portable Exoskeleton
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of using of a portable exoskeleton for walking training in persons with Parkinson's disease that have gait mobility problems and/or postural instability.
详细描述
This is a feasibility study to examine a novel application of state-of-the-art robotic-assist gait training to improve mobility in people with Parkinson's disease (PD). The study will investigate the utility of the Keeogo® exoskeleton (a robotic-assist gait training device) for people with PD. The Keeogo® offers advantages of being lightweight and portable (for eventual home use) and is relatively quick to attach and remove. The aims here are to establish the safety of the Keeogo® for gait training in persons with PD and to preliminarily assess the potential efficacy of the Keeogo® for better balance control, gait mobility and fall reduction in persons with PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's Participant
- •age 21 years or older,
- •PD confirmed by a movement disorder specialist using UK Brain Bank Criteria,
- •H&Y stage II, III, IV, or V.
- •Caregiver participant
- •Caregiver of PD participant and is willing to complete questionnaire
- •moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30) except in cases where the clinician and the participants Legally Authorized Representative both determine the participant can safely complete the study
排除标准
- •Parkinson's Participant
- •neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of gait, stance, balance or coordination,
- •history of implantable cardiac device or ablative surgery,
- •moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30),
- •uncontrolled orthostatic hypotension,
- •feeding tube or associated port placement (PEG/J-PEG),
- •body height less than 5'1" or greater than 6'3" and
- •body weight greater than 250 pounds.
- •Caregiver participant
- •Unwilling to complete questionnaire
研究组 & 干预措施
PD participants
Subjects will participate in a total of 10 walking sessions, twice per week for 5 weeks, while wearing a robotic-assist gait training device. There will also be 3 additional visits for assessments at: baseline (up to 1 prior to treatment), post (1 week after last treatment), and final (4-6 weeks after last treatment).
干预措施: Robotic-assist gait training device (Device)
结局指标
主要结局
Safety of the Portable Exoskeleton
时间窗: At the end of treatment (5 weeks)
Number of "prevented" or "near falls" requiring physical assistance by the investigative training team experienced by the participant during throughout the training.
次要结局
- Change in Walking Capacity(6 weeks)
- Change in Balance(6 weeks)
- Change in Freezing of Gait (FOG)(6 weeks)
- Change in Motor Symptoms(6 weeks)
- Change in Caregiver QOL(6 weeks)
- Change in Quality of Life (QOL)(6 weeks)