Early Implementation of MAKv1 Exoskeleton in TKA Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Serious Adverse Events
研究概览
简要总结
The present study analyzes the effects of using a portable single limb exoskeleton (MAKv1) in patients with total knee artrhoplasty (TKA). Safety, usability and clinical effects of an early intervention program with the device with an early implementation are studied.
详细描述
The present study will analyze the safety, usability and clinical effects of using the MAKv1 exoskeleton in TKA patients. The intervention will consist of 1 hour sessions with the MAKv1 device, thrice per week during 1 month. Safety measurements (serious adverse events, vitals, and auto-perceived pain) will be collected at each session with the device, along with the repetitions performed at each exercise assisted with the device. After the first week is completed, measurements regarding clinical effect will be collected. Also, at the end of the month were the participants receive the sessions with the device, clinical effects will be measured again, along with a questionnaire to collect the users' perception of the device (QUEST 2.0).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing TKA surgery
排除标准
- •inability to understand simple instructions
- •postoperative complications that may be a risk to use the exoskeleton
- •other conditions that prevented mobilisation in early stages after TKA
- •weight > 100 kg
- •size < 150 cm
- •size > 190 cm
研究组 & 干预措施
MAKv1
The MAKv1 group will receive 1 hour of MAKv1 rehabilitation, thrice per week during 1 month
干预措施: MAKv1 (Device)
结局指标
主要结局
Serious Adverse Events
时间窗: Through study completion, an average of 2 months
event that causes death, life-threat, hospitalization, disability, congenital anomaly, or that requires intervention to prevent permanent impairment or damage
次要结局
- Auto-perceived Pain(Through completion of the use of the device, during 1 month)
- Blood pressure(Through completion of the use of the device, during 1 month)
- Muscle strength at the knee(Mesaured at the first week, at the first month and at the second month (follow-up) from participation)
- Knee circumference(Mesaured at the first week, at the first month and at the second month (follow-up) from participation)
- Quadriceps circumference(Mesaured at the first week, at the first month and at the second month (follow-up) from participation)
- Oxygen Saturation(Through completion of the use of the device, during 1 month)
- Body Termperature(Through completion of the use of the device, during 1 month)
- TUG(Mesaured at the first month and at the second month (follow-up) from participation)
- FAC(Mesaured at the first month and at the second month (follow-up) from participation)
- Heart Rate(Through completion of the use of the device, during 1 month)
- Range of Motion at the knee(Mesaured at the first week, at the first month and at the second month (follow-up) from participation)
- Repetitions per exercise(Through completion of the use of the device, during 1 month)
- QUEST 2.0 scale(At the first month of the participation in the trial)
- 6MWT(Mesaured at the first month and at the second month (follow-up) from participation)