Continuation of the Exploration of the Standing Seated Passage of the Hemiplegic for the Realization of a New Transport Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Time required to carry out each step of use of the device
研究概览
简要总结
This is a study for a new mechanical transport device adapted to the hemiplegic patients.
Healthy volunteers :
After explaining the protocol and presenting the movement laboratory, the subjects are equipped with reflective markers on the 4 limbs, the trunk and the head. The subjects are installed on a seat positioned in front of 2 force platforms installed on the ground. The seat is equipped with a force platform.
Phase 1 :
After being seated, the subject realizes :
- 3 seat to stand and stand to seat without assistance
- 3 seat to stand and stand to seat using a handle located in front of it (handle equipped with a 6-axis force sensor)
- 3 seat to stand and stand to seat using the experimental device This phase will last 45minutes (mn) (30mn of equipment and 15mn of sitting passengers standing)
Phase 2:
After being seated, the subject performs a course comprising:
- A standing pass from sitting on a chair
- A straight line movement
- A succession of left and right turns
- An upward and downward travel of less than 1%.
- Standard doorway
- Standing on the toilet
- A sitting pass from the toilet
- One way to a bed
- A sitting pass on the bed
- A passenger seat sitting upright from the bed
- A return to the starting point
- A sitting pass on the starting chair Each stage is timed. A subjective analysis of each step is done by a lickert scale on the perceived comfort and safety.
This phase 2 will last 30mn (15mn of course and 15mn of questions).
Hemiplegic subjects :
At each session, the subject is examined by a physician who evaluates the motor control (Fugl Meyer scale), the equilibrium (Berg scale) and the spatial hemineglect (Bergego scale).
Phase 1 is performed except the 3 seat to stand and stand to seat without assistance which are impossible.
Phase 2 is performed. An evaluation of the device over 4 hours is carried out for each subject in therapeutic apartment in simulated living conditions. The validation in living lab is carried out by an ergonomist and by a questionnaire on the comfort and safety of the various steps identified by the ergonomist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers :
- •aged 18-75 years
- •Subject having given his consent
- •Free from any neurological or cardiorespiratory locomotor pathology that may interfere with standing seated passages.
- •Hemiplegic patients :
- •Left hemiplegia in one of the following groups :
- •Walking with difficulty or not walking and able to stand with a stick or an armrest
- •Walking difficult or not walking and unable to stand with a cane or an armrest.
- •aged 18-90 years
- •Subject having given his consent
- •Subjects with a trunk balance to sit without support
排除标准
- •aged less than 18 or more than 75 (healthy volunteers) or more than 90 (hemiplegic subjects)
- •Pain during seated-standing passages
- •Unstable medical condition
- •Unable to consent
- •Subject under legal protection
- •Left-hemineglect making standing or seated (wheelchair) displacements impossible autonomously (for hemiplegic patients)
结局指标
主要结局
Time required to carry out each step of use of the device
时间窗: Day 1
Each step of phase 1 and phase 2 will be timed.
次要结局
- Record of all adverse reactions.(Day 1)