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临床试验/ISRCTN69371850
ISRCTN69371850已完成3 期

Robot Assisted Training for the Upper Limb after Stroke (RATULS): a randomised interventional phase III study

ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 770 人开始时间: 2013年10月4日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
770

研究概览

简要总结

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28728602 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31128926 (added 29/05/2019) 2021 economic evaluation results in https://pubmed.ncbi.nlm.nih.gov/34035087/ (added 27/05/2021)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Adults with a first ever stroke who fulfil the following criteria are eligible:
  • 1. Age 18 years and over
  • 2. Clinical diagnosis of stroke (cerebral infarction, primary intracerebral haemorrhage, subarachnoid haemorrhage)
  • 3. Between one week and five years since stroke
  • 4. Moderate to severe upper limb functional limitation (Action Research Arm Test (ARAT) score 0-39) due to stroke
  • 5. Able to provide consent to take part in the study and to comply with the requirements of the protocol

排除标准

  • 1. More than one stroke (patients with previous transient ischaemic attack (TIA) may be invited to participate)
  • 2. Other current significant impairment of the upper limb affected by stroke e.g. fixed contracture, frozen shoulder, severe arthritis, recent fracture
  • 3. Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. registered blind
  • 4. Previous use of the InMotion robotic gym system or other arm rehabilitation robot
  • 5. Current participation in a rehabilitation trial evaluating upper limb rehabilitation after stroke
  • 6. Previous enrolment in this study

研究者

发起方
ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

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