Funzionalità e Sicurezza di un Dispositivo di Ginocchio Per Riabilitazione Della Deambulazione Con Pazienti Neurologici
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of device-related adverse events
研究概览
简要总结
This clinical investigation aims to evaluate the safety, feasibility, and preliminary performance of the AKO-R wearable robotic device for knee assistance during walking. The study involves participants performing treadmill and overground gait training under supervised conditions, with the device providing assistive torque to support movement. Clinical and functional outcomes are assessed using validated measurement tools, while additional data are collected to characterize user performance and interaction with the device. The study is designed as an exploratory investigation to gather evidence supporting the clinical use and further development of the device. Primary outcomes regards safety of the device and preliminary clinical benefit on gait symmetry.
详细描述
The study is structured in 5 sessions. The first and last session are the assessment. the 2nd session is the session for calibration of the exoskeleton parameters. The 3rd session is for exo familiarization and the 4th exo is for exo-assisted condition evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed stroke with fMRI
- •within 2 years from stroke event
- •height [1.5 - 2]m
- •weigth <= 100 Kg
排除标准
- •Pregnancy
- •Implanted cardiac devices, such as pacemakers or implantable cardioverter defibrillators (ICDs)
- •Recent or current participation in research studies that, in the opinion of the Principal Investigator, may affect the subject's response to the study intervention
- •Severe aphasia
结局指标
主要结局
Number of device-related adverse events
时间窗: through study completion, an average of 1 year
Step Length Symmetry Index Change
时间窗: Day 4
The Step Length Symmetry Index (SI) will be compared across conditions. Descriptive data are averaged across \>20 steps. Score closer to 0 means a better outcome.
Stance Time Symmetry Index Change
时间窗: Day 4
The Stance Time Symmetry Index (SI) will be compared across conditions. Descriptive data are averaged across \>20 steps. Score closer to 0 means a better outcome.
次要结局
- Range of motion Change(Day 4)
- Self-selected velocity Change(Day 5)
- Endurance(Day 5)
- Usability score(Day 5)
- Acceptability(Day 5)
- Satisfaction Score(Day 5)