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Low Level Laser Intervention for Individuals With Knee Osteoarthritis

2021年6月21日 更新者:National Cheng-Kung University Hospital

The Effects of Low Level Laser Intervention on Muscular Strength for Individuals With Knee Osteoarthritis

The purpose of this study was to investigate the intervention effects of low level laser for knee OA group

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

56

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tainan、台湾、701
        • Department of Physical Therapy, National Cheng-Kung University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • The severity of osteoarthritis was defined by the Kellgren-Lawrence system as grade 2 - grade 3

Exclusion Criteria:

  • Uncontrolled hypertension
  • Malignant tumor
  • Skin cancer
  • Pregnant
  • Dysesthesia
  • Pacemaker inplement
  • Cognitive problem
  • Fall record within 6 months
  • Dysfunction of blood coagulation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:808nm
The wavelength of this experimental group was 808nm, total power: 3.6W, 15 minutes a session, 3 times a week for 8 weeks
The intervention protocol includes 2 wavelength as the experimental group, each of the were 808nm, 660nm, and 1 placebo intervention which output total power is only 0.0072W.
有源比较器:660nm
The wavelength of this experimental group was 660nm, total power: 3.6W, 15 minutes a session, 3 times a week for 8 weeks
The intervention protocol includes 2 wavelength as the experimental group, each of the were 808nm, 660nm, and 1 placebo intervention which output total power is only 0.0072W.
安慰剂比较:Control
The wavelength of control group, total power: 0.0072W, 15 minutes a session, 3 times a week for 8 weeks
The intervention protocol includes 2 wavelength as the experimental group, each of the were 808nm, 660nm, and 1 placebo intervention which output total power is only 0.0072W.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Changes of muscular strength of thigh measured by handheld dynamometer
大体时间:Baseline and after treatment, 8 weeks intervention
Muscular strength of the knee extensor and flexor on both sides and will be normalized by the body weight of participants' (lb/kg)
Baseline and after treatment, 8 weeks intervention

次要结果测量

结果测量
措施说明
大体时间
Changes of walking speed measured by the stop watch
大体时间:Baseline and after treatment, 8 weeks intervention
40-m walk test, participants are instructed to walk as fast as they could, investigator records the time they spend. (seconds)
Baseline and after treatment, 8 weeks intervention
Changes of stair climbing ability measured by the stop watch
大体时间:Baseline and after treatment, 8 weeks intervention
stair climbing test, participants are instructed to climb stairs with a total height of 180 cm as fast as they could, investigator records the time they spend. (seconds)
Baseline and after treatment, 8 weeks intervention
Changes of chair stand ability, the stop watch will be used to measure time and investigators count the time that participants complete
大体时间:Baseline and after treatment, 8 weeks intervention
sit-to-stand test, participants are instructed to repeat chair stand movement as fast as they could, investigator records the times they complete. (times)
Baseline and after treatment, 8 weeks intervention
Changes of dynamic balance ability measured by the stop watch
大体时间:Baseline and after treatment, 8 weeks intervention
timed UP&Go test, participants are instructed to stand up from a chair and walk as fast as they could for 3 meters and back to the chair, investigator records the time they spend. (seconds)
Baseline and after treatment, 8 weeks intervention

其他结果措施

结果测量
措施说明
大体时间
Changes of joint range of motion measured by the goniometer
大体时间:Baseline and after treatment, 8 weeks intervention
Joint range of motion of the hip flexion, internal and external rotation, knee flexion, extension on both sides(degrees)
Baseline and after treatment, 8 weeks intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Cheng-Feng Lin, Ph.D、Department of Physical Therapy, National Cheng-Kung University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年11月9日

初级完成 (实际的)

2021年6月4日

研究完成 (实际的)

2021年6月4日

研究注册日期

首次提交

2021年2月3日

首先提交符合 QC 标准的

2021年3月31日

首次发布 (实际的)

2021年4月2日

研究记录更新

最后更新发布 (实际的)

2021年6月22日

上次提交的符合 QC 标准的更新

2021年6月21日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • A-ER-109-187

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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