Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Walking Index for Spinal Cord Injury II
研究概览
简要总结
Patients with incomplete spinal cord injury
详细描述
The objective of this project is to verify the effects of suspended robotic gait training (Lokomat) in recovery of functional capacity of the lower limbs patients with incomplete spinal cord injury.
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
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological diagnosis of incomplete spinal cord injury of traumatic origin
- •Injury time from 1 to 36 months
- •Stability verified in clinical medical evaluation
- •ASIA C or D
- •Absence of severe psychiatric amendment requiring psychiatric evaluations
- •Present functional recovery of the upper limb compatible with stages III and IV of Brunnstrom
- •Patients cannot use a cardiac pacemaker ; have unstable angina or other decompensated heart disease; have chronic obstructive pulmonary disease; dysreflexia without having autonomic control; have some fracture of the bones of the lower limbs; tracheostomy; presenting deformity and stiffness of the hip joint, knee (20 ° or more of flexion ) and ankle ( 10 or more plantar flexion ) and pressure ulcers.
- •Absence of illicit drug use
- •Grant writing the informed consent to participate in the study
排除标准
- •Lack of resistance
- •Disabling fatigue
- •Worsening of spasticity which prevents the movement
- •Body weight in excess of 150Kg
- •Risk of osteoporosis with pathological fracture
- •Asymmetry in the lower limbs greater than 2 cm
- •Skin lesions and / or pressure ulcers in areas where the orthosis Lokomat pressuring
研究组 & 干预措施
Interventional group
A group with spinal cord injury will be trained in a 30-minute session 5 times weekly for 6 weeks. Each session will be supervised by qualified staff. Patients will undergo training with gradual increase in load and speed, according to the tolerance of each patient. The body weight support progression will start at 50 % of the patient body weight. It will be changed every 2 weeks and the load will decrease 10%. The progression of speed may be accompanied during the training period. For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.
干预措施: Training sessions (Other)
Interventional group
A group with spinal cord injury will be trained in a 30-minute session 5 times weekly for 6 weeks. Each session will be supervised by qualified staff. Patients will undergo training with gradual increase in load and speed, according to the tolerance of each patient. The body weight support progression will start at 50 % of the patient body weight. It will be changed every 2 weeks and the load will decrease 10%. The progression of speed may be accompanied during the training period. For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.
干预措施: Lokomat system (Hocoma AG Switzerland) (Device)
结局指标
主要结局
Walking Index for Spinal Cord Injury II
时间窗: 6 weeks after treatment
次要结局
未报告次要终点