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临床试验/NCT01511796
NCT01511796Unknown3 期

Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function

Toronto Rehabilitation Institute2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
3 期
入组人数
38
试验地点
2
主要终点
Modified Ashworth

研究概览

简要总结

The purpose of this study is to examine the effects of a combination of "Botulinum Toxin (BT) and Upper Limb (UL) rehabilitation" compared to "BT only" on UL motor function in adults with spasticity after stroke using a pre-post design. The research question is whether combination of BT and UL rehabilitation compared to BT only is more effective in improving the UL function, range of motion and pain.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 18 years of age
  • at least 4 months post stroke
  • present with UL spasticity (MAS >1 in elbow and/or spasticity of the hand, wrist or shoulder)
  • present with at lease a stage 3 of CMSA
  • able to comply with the requirements of the protocol and UL therapy programme.

排除标准

  • significant cognitive and speech impairments
  • other upper limb impairments such as frozen shoulder
  • another diagnosis which could contribute to upper limb spasticity .

结局指标

主要结局

Modified Ashworth

时间窗: up tp 2013

次要结局

  • Goal attaiment Scale(up tp 2013)

研究者

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

Parvin Eftekhar

principal inverstigator

Toronto Rehabilitation Institute

研究点 (2)

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