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临床试验/NCT04034108
NCT04034108已完成不适用

Early Surgical Intervention Combined With Weight-supported Walking Training Improves Neurological and Locomotor Recoveries in 339 Clinically Complete Human Spinal Cord Injuries

Kunming Tongren Hospital2 个研究点 分布在 1 个国家目标入组 339 人开始时间: 2000年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
339
试验地点
2
主要终点
Change of Kunming Locomotor Scale (KLS)

研究概览

简要总结

To determine the efficacy of a novel combinatorial treatment involving early surgical intervention and long-term weight-bearing walking training in spinal cord injury (SCI) patients clinically diagnosed as complete or American Spinal Injury Association Impairment Scale Class A (AIS-A).

详细描述

In the present study, the investigators reported the efficacy of a novel combinatorial approach involving early surgical intervention and long-term weight-bearing walking training in SCI patients clinically defined as complete or AIS-A. The surgical intervention involves the intradural decompression (via durotomy), and, in some cases, intraspinal decompression (via myelotomy). In addition, the investigators had developed a weight-bearing walking training program named "Kunming Locomotion Training Program (KLTP)" to train the patient to walk actively for a duration of 6 hours per day, 6 days per week for a minimum of 6 months (6-6-6 KLTP). The investigators reasoned that early surgical intradural and/or intraspinal decompression would release the intraspinal pressure and, therefore, spare surrounding tissues that would otherwise degenerate during the course of secondary injury. The investigators further reasoned that long-term weight-bearing walking training would "retrain" the residual spinal pathways facilitating recovery of locomotor function, and that a combination of the two would result in even greater functional recoveries.

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
4 Years 至 76 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • injury levels included cervical, thoracic and lumbar spinal levels;
  • neurological examination was AIS-A;
  • diagnosis of SCI was confirmed by MRI.

排除标准

  • penetrating injuries that caused complete transection of the spinal cord;
  • patients with severe brain injuries or other neurological disorders;
  • patients with lower motoneuron diseases;
  • patients with other conditions including pregnancy, and significant medical, infectious, and psychiatric conditions.

研究组 & 干预措施

Experiment group

Experimental

All the patients were classified as AIS-A at the time of admission to the clinical center. The MRI was performed in all cases prior to and after the surgery. Surgeries were performed between 12 hours to 30 days after trauma. At 15 days after surgery, with protection of a tailored chest-waist cast made of polyurethane 8 foam for thoracic/lumbar injuries or a neck support for cervical injuries, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers.

干预措施: Surgical intervention combined with weight-supported ambulation training (Procedure)

结局指标

主要结局

Change of Kunming Locomotor Scale (KLS)

时间窗: Before surgery, Day 15, Month 3, and Month 6

Kunming Locomotor Scale is a 10-grade Roman numeral locomotion scoring system. Grade I, the patient can not stand; grade II, the patient is able to stand with weight support and help in fixing the knee; grade III, the patient is able to stand with weight support; grade IV, the patient is able to walk with wheeled weight support and help in fixing the knee of the weight bearing leg; grade V, the patient is able to walk with wheeled weight support; grade VI, the patient is able to walk with the help of a light four-leg support; grade VII, the patient is able to walk with a pair of crutches; grade VIII, the patient is able to walk with a cane; grade IX, the patient is able to walk without support but staggeringly; and grade X, the patient is able to walk stably without support.

次要结局

  • Magnetic Resonance Imaging(Before surgery)
  • Change of American Spinal Injury Association Impairment Scale (AIS)(Before surgery (baseline), Day 15, Month 3, and Month 6)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Hui Zhu

Director of Department

Kunming Tongren Hospital

研究点 (2)

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