Robotic Assisted Balance and Exoskeleton Training (REACTION) in Neurorehabilitation: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- DON/DOFF
研究概览
简要总结
The goal of this clinical trial is to explore the effect on walking speed of a new robotic assisted balance and gait trainer (REACTION) and their subsystems in individuals with neurological disorders. The study will provide insight in the feasibility of REACTION.
Participants will:
- Participate in two sessions in which every session contains a walking task and balance tasks
- end the study with a semi-structured interview
详细描述
The first day will be focusing on 4 conditions: tasks without aid, tasks with regular aid, task with the ABLE Regain and tasks with REACTION. The first and third condition consist of a walking task and balance tasks, The second and fourth condition is only focusing on the walking task with the aim of getting familiar to the device and the walking task.
The second day will also be focusing on four conditions: tasks without aid, tasks with aid, tasks with the GABLE Core and task with REACTION (Fig 3.2). The conditions 'tasks without aid', 'tasks with the GABLE Core' and 'tasks with REACTION' consist of a walking task and balance tasks (similar to day 1). The condition 'tasks with aid' only consists of a walking task.
A semi-structured interview with the corresponding physiotherapist and patient will be held to gather more information about usability and feasibility of REACTION from a therapist's and patient's perspective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a participant must meet all of the following criteria:
- •Age > 16 years
- •Able to give informed consent
- •Stroke patients:
- •first-ever ischemic or haemorrhagic stroke
- •FAC score between 3 and 4
- •(Sub)acute or chronic phase
- •SCI patients:
- •Neurological injury levels ranging from C5 to T9
- •Motor incomplete spinal cord injury (ASIA impairment score of C or D)
- •Able to walk independently (without physical support)
排除标准
- •A potential participant who meets any of the following criteria will be excluded from participation in this study:
- •Premorbid disability of lower extremity
- •Progressive neurological diseases like dementia or Parkinson
- •Skin lesions or severely impaired sensation at the hemiparetic leg
- •Contraindication for mobilization, like lower limb fracture
- •Insufficient knowledge of the Dutch language to understand the purpose or meth-ods of the study
- •Pregnancy
研究组 & 干预措施
Experimental arm
干预措施: REACTION (Device)
Experimental arm
干预措施: ABLE Regain (Device)
Experimental arm
干预措施: GABLE Core (Device)
结局指标
主要结局
DON/DOFF
时间窗: 1 week
The time to put the device on (DON) and the device off (DOFF)
次要结局
- Kinematic data(1 week)
- Short Form Berg Balance Scale (SFBBS)(1 week)
- Level of Assistance(1 week)
- Walking speed(1 week)