Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Weight Bearing Capacity
研究概览
简要总结
The purpose of this experiment is to evaluate the efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients after Spinal Cord Injury
详细描述
The whole course will last around 12 months, during which there will be: Pre-implant evaluations and standard rehabilitation (6-10 weeks), Stimulator implantation and stimulation optimization (4-8 weeks), Rehabilitation training with stimulation (6 months). At the end of the protocol, the study aims to make the patients walk better and faster.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~70
- •Spinal cord injury staging(AIS) A,B,C or D
- •Level of lesion is T10 and above
- •Distance between lesion and conus >60mm
- •Injured Time > 3 months
- •Capable of participating rehabilitation program
- •Agree to comply with all conditions of the study and to attend all required study training and visits
排除标准
- •With Obvious psychiatric disorder that cannot complete relevant questionaires
- •Cognitive impairment
- •Severe autonomic reflex disorder
- •Severe muscle atrophy and joint contracture
- •Cannot participate in spinal cord stimulation surgery or follow-up visits
- •Life expectancy less than 12 months
- •Abnormal blood or other physiological examinations that cannot conduct surgery, such as blood coagulation disorder or kidney/liver abnormalities
- •Uncontrollable hypertension, heart diseases, respiratory diseases or took related medicine in last 3 months
- •Unsuitable candidates in PI's perspective
结局指标
主要结局
Weight Bearing Capacity
时间窗: Change from Baseline to the 8 month after implantation.
Weight-bearing capacity (WBC) is an important outcome to monitor and particularly relevant in patients with severe motor impairments who cannot walk independently. The investigators use LPG HUBER360 to examine subjects' weight bearing capacity
WISCI III
时间窗: Change from Baseline to the 8 month after implantation.
A Common method used to evaluate SCI patient's walking capability in clinical setting
10-metre Walking Test 10-metre Walking Test 10-metre Walking Test 10 meter wlaking
时间窗: Change from Baseline to the 8 month after implantation.
10-Meter Walk Test (10MWT) is commonly used to measure walking speeds during two conditions: a self-selected normal speed, and a self-selected 'faster-than-normal' speed.
次要结局
未报告次要终点
研究者
Luming Li
Director of National Engineering Laboratory for Neuromodulation
Tsinghua University