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临床试验/NCT03031223
NCT03031223Unknown不适用

Evaluation of Sensory-motor Response to Low-level Laser Therapy for the Treatment of Spinal Injuries - Protocol for a Randomized, Controlled, Clinical Trial

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Electromyography

研究概览

简要总结

Spinal cord injuries have become increasingly frequent due mainly to the increase in urban violence. The growing number of automobile collisions and violence-related events merits particular attention, as such occurrences can lead to death or disability stemming from a spinal injury. The severity of the consequences depends on the location affected and degree of destruction of afferent and efferent spinal cord pathways, with higher, more extensive injuries leading to less physical fitness and functional independence. Unfortunately, injured neurons of the central nervous system are unable to regenerate following a spinal injury and spinal cord regeneration is therefore a major challenge to researchers in the fields of neuroscience and neurologia. Upon receiving an external stimulus, the central nervous system is believed to adapt and reorganize itself using mechanisms to compensate for neuronal loss and promote, even if partially, the remodeling of remaining synaptic connections, leading to new neuronal sprouting. Low-level laser therapy (LLLT) has proven to be a possible option for the stimulation of the repair process in the central nervous system. It is plausible that this type of therapy can offer the same benefits previously established in other types of tissues, the stimulation of bone formation, neovascularization and the regeneration of peripheral nerves. Research groups have investigated the efficacy of LLLT for the treatment of spinal cord injuries and have demonstrated that laser therapy administered simultaneously to an injured sciatic nerve and corresponding segment of the spinal cord accelerates the regeneration process of the injured peripheral nerve.

详细描述

General objective - Evaluate the effect of LLLT on the sensory-motor response in individuals having suffered a spinal cord injury.

Specific objectives - Investigate the maintenance of the possible sensory-motor response through electromyographic analyses conducted before LLLT and as well as one, 15, 30, 45 and 60 days after the intervention; evaluate functional independence and quality of life in individuals having suffered a spinal cord injury.

Trial design - A randomized, controlled, clinical trial is proposed. displays the flowchart of the development of the study. The trial will be conducted in compliance with the norms governing research involving human subjects and will be submitted for the approval of the Institutional Review Board of University Nove de Julho, São Paulo, Brazil. All participants or their legal guardians will receive clarifications regarding the objectives and procedures of the study and those agreeing to participate will sign a statement of informed consent.

Methods: Participants, interventions and outcomes

Study setting - Physical Therapy Clinics of University Nove de Julho, São Paulo, Brazil Exclusion criteria: complete spinal cord injury, cognitive impairment.

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 (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • partial spinal injury;
  • patients with tetraplegia or paraplegia;
  • injury between C3 and L5;
  • up to one year elapsed since injury.

排除标准

  • complete spinal cord injury;
  • cognitive impairment.

结局指标

主要结局

Electromyography

时间窗: 15 days after the intervention

Pre and post-laser electromyography

次要结局

未报告次要终点

研究者

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

Fernanda Cordeiro da Silva

Principal Investigator

University of Nove de Julho

研究点 (2)

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