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临床试验/NCT01448980
NCT01448980已完成3 期

The Efficacy of Thai Traditional Massage in Decreasing Spasticity for Elderly With Stroke

Mahidol University2 个研究点 分布在 1 个国家目标入组 396 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
396
试验地点
2
主要终点
Modified Ashworth scale (MAS)

研究概览

简要总结

Stroke is one of the common diseases in the elderly. It is the third ranking cause of death and affects health care system in our country. One of the most important consequences of stroke is spasticity. Some stroke patients suffered from severe spasticity or hypersensitive reflex to stimuli. It can cause contracture, limit self care function, transfer or ambulation. Most of stroke patients have to depend on their relatives or families.

详细描述

Thai traditional massage is one of the popular alternative medicine in Thailand. Lots of stroke patients who suffered from spasticity sought treatment. To the investigators knowledge, there is no study concerning efficacy of massage in decreasing spasticity for stroke patients.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke with onset of >=6 months
  • Age >=50 years
  • Spasticity grade of knee flexor or elbow flexor was 2-3 classified by Modified Ashworth scale (MAS)
  • Ability to follow command and communicable

排除标准

  • Having contraindications for massage including fever > 38 degree, uncontrolled blood pressure, bleeding tendency, on anticoagulant drug, having ulcer or healing fracture of limbs, contamination skin disease, severe osteoporosis
  • Serious contact diseases, for example AIDS, TB
  • History of malignancy
  • Fixed joint contracture at elbow or knee of paralyzed limb
  • History of botulinum toxin injection or Phenol/Alcohol nerve block within 3 months
  • Previous history of TTM
  • Severe dementia or uncontrolled psychiatric problems

结局指标

主要结局

Modified Ashworth scale (MAS)

时间窗: 6 weeks

The massage will be considered success if MAS decreased at least 1 level after treatment.

次要结局

  • Modified Barthel index (BI)(6 weeks)
  • Hospital anxiety depression score (HADS)(6 weeks)
  • Thai Pictorial Quality of Life questionnaire(6 weeks)

研究者

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

Vilai Kuptniratsaikul

Rehabilitation Medicine Department, Siriraj Hospital

Mahidol University

研究点 (2)

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