Responses on Use of Standing Frame and "Innowalk Pro" in Subacute Patients With Severe Functional Deficits Due to Acquired Brain Injury.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
This study will explore physical and physiological responses to mobilization of patients with acquired brain injuries in subacute phase using a classic standing frame and a standing device with simultaneous passive movement of legs, "Innowalk Pro".
详细描述
Several studies underline the importance of early mobilization of patients with brain injuries, leading to shorter hospital stays, less contractures, and improved general function.
The routine mobilization treatment in the rehabilitation of patients with severe brain injuries in Sunnaas Rehabilitation Hospital is initial use of a tilt table where tilt angle is gradually increased, and when tolerated, standing in a classic standing frame where the patient's lower body is fixed to the device in an upright standing position.
"Innowalk Pro" is a robotic standing device where legs are fixed, but passively moved by electric motors in an upright standing position. An assumption is that standing in "Innowalk Pro" might be better tolerated at an earlier stage of rehabilitation than standing in a classic standing frame.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe brain injury / stroke <1 year post injury.
- •Medically stable
- •Paresis in lower extremities, minimal walking function (even with personal assistance) (FIM movement (walk), score 1-2)
- •Planned stay in Sunnaas RH for a minimum of 2 weeks from time of inclusion
- •Tolerate 5 minutes in 40 degrees 'upright' position in tilt table (custom orthostasis test)
- •Body weight ≤95 kg
- •Body height ≤190 cm
排除标准
- •Fractures in the lower extremities or in the columna with movement or strain restrictions or with pain.
- •Aggressive and provocative behavior that affects the ability to collaborate.
- •Other conditions where upright position is contraindicated
研究组 & 干预措施
"Innowalk Pro"
Use of a new device; "Innowalk Pro"
干预措施: Use of a new device; Innowalk Pro (Device)
Standing frame
Use of standard standing frame
干预措施: Use of standard standing frame (Device)
Standing frame
Use of standard standing frame
干预措施: Use of a new device; Innowalk Pro (Device)
"Innowalk Pro"
Use of a new device; "Innowalk Pro"
干预措施: Use of standard standing frame (Device)
结局指标
主要结局
Blood pressure
时间窗: Up to one week
Blood pressure is monitored continuously
Standing time in minutes
时间窗: Up to one week
Tolerated maximal standing time in each standing device.
次要结局
- Number of near faints will be registered by the staff.(up to one week)
- Muscle activity in legs(up to one week)
- Rate of skin issues(up to one week)
- Spasticity(up to one week)
- Perceived exertion(up to one week)
- Heart rate(up to one week)
- Number of patients reporting pain(up to one week)