跳至主要内容
临床试验/NCT01308216
NCT01308216终止1 期

Efficacy of Transcranial Laser Therapy for Improving Upper Extremity Functional Recovery in Hemiplegic Patients From Ischemic Stroke

Hospital Universitario Ramon y Cajal2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年11月1日最近更新:
适应症

试验速览

阶段
1 期
状态
终止
发起方
入组人数
25
试验地点
2
主要终点
Fugl-Meyer Scale

研究概览

简要总结

The aim of this study is to determine the efficacy of transcranial laser therapy applied in automatic noncontact scanning mode for improving functional disability in patients with hemiplegia from ischemic stroke undergoing a rehabilitation program.

详细描述

Transcranial laser therapy is applied with an InGa(Al)As diode laser.The laser in automatic scanning is applied over both cerebral hemisphere during 15 sessions. Patients simultaneously performed a program of therapeutic exercises 3 days a week. Outcome measures were the Fugl-Meyer Upper Extremity scale, which assessed upper limb motor function, and the Barthel index, which assessed general functional disability.

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
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with hemiplegia secondary to cerebral stroke ischemic.
  • Requirement of shaving the scalp area.
  • Initiation of the TLT procedure begins between 70 and 100 days after stroke onset.
  • Informed written consent before enrolling in the study.

排除标准

  • Hemiplegia secondary to hemorrhagic stroke.
  • Metallic brain implants.
  • Neurodegenerative disorders.
  • Bilateral motor problems.

结局指标

主要结局

Fugl-Meyer Scale

时间窗: 20 minutes

The upper extremity Fugl-Meyer subscale (0-66) considers flexor and extensor synegies as well as reflex activity and coordination and is specific for grading motor impairments.

次要结局

  • Barthel index(10 minutes)

研究者

发起方
Hospital Universitario Ramon y Cajal
申办方类型
Other
责任方
Principal Investigator
主要研究者

RAMON MONTES MOLINA

Physical Therapy

Hospital Universitario Ramon y Cajal

研究点 (2)

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