Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point
研究概览
简要总结
The purpose of this research is to compare the effectiveness of a training protocol integrating Brain-machine Interfaces, Visuo-tactile feedback and Assisted Locomotion (referred to as the Walk Again Neurorehabilitation protocol, or WANR), with classical physiotherapy training for patients with chronic complete paraplegia due to spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Discomplete spinal cord injury;
- •Traumatic etiology;
- •American Spinal Injury Association Impairment Scale(ASIA) A grade;
- •The level of SCI in T9-T12;
- •≥12 months post injury;
- •Considered independents to perform daily life activities: feeding, dressing, capability with wheelchair;
- •Emotional stability;
排除标准
- •Absence of SCI, or presence of multi-segmental injury;
- •SCI non-traumatic etiology;
- •Age<18 years or Age>60 years;
- •Emotional instability;
- •Unavailable time to join the protocol activities;
- •Already enrolled in other research protocol;
- •Acute or chronic decompensated comorbidities (e.g. Hypertension, Diabetes, cardiomyopathy, chronic respiratory insufficiency, chronic renal insufficiency, hepatopathy, or any other neurological disorders besides the SCI);
- •Alcohol/drugs abuse and dependence;
- •Psychiatric disorders (exception: treated depression);
- •10.Cognitive deficit; visual deficit; auditory deficit;
- •Incapacitating pain;
- •Presence of limb amputations (exception: hand distal phalanges);
- •Peripheral neuropathy associated (e.g.: brachial plexus injury, carpal tunnel syndrome);
- •Muscle injury associated (e.g. myotendinous rupture, burning injury, muscle-compartment syndrome);
- •Neuromuscular disease associated (ex: myopathy) or lower limb fractures within the past six months;
- •Movement disorders(e.g. ataxia);
- •Use of medication that can negatively impact on neurological/motor recovery;
- •Presence of joint deformities, presence of fractures;
- •Lower limb spasticity MAS (Modified Ashworth Scale)>2;
- •Pressure ulcer: considering grade 3 or 4, injury size and body location;
- •Cephalic metallic /magnetic implants (exception: MRI compatible implants);
- •Presence of cardiac or neural pacemaker;
- •Use of devices/tubes: tracheostomy, gastrostomy, nasogastric, long-term bladder catheterization, cystostomy, colostomy, totally implanted catheter system, arteriovenous dialysis fistula;
- •Severe osteoporosis (Tscore>-4);
- •Syringomyelia;
- •Lokomat or ZeroG training within the prior 3 months.
研究组 & 干预措施
WANR protocol
Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion
干预措施: Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol (Device)
Classical physiotherapy protocol
Training with classical physiotherapy protocol
干预措施: Training with traditional physiotherapy protocol (Device)
结局指标
主要结局
The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point
时间窗: After nine-months of training
The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function) for 5 lower extremity muscle groups with a 50-point maximum (25 per side)
次要结局
- The change of nociception improvement: ASIA pin-prick sensory score(After nine-months of training)
- Change of WHO-QoL bref(After nine-months of training)
- Improvement of Walking index for SCI (WISCI)(After nine-months of training)
- Change of post-void residual urine(After nine-months of training)