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临床试验/NCT01394809
NCT01394809已完成不适用

Effects of Motor Cognitive Training on Functional Loss Through Immobilization After Osteoporotic Distal Radius Fractures: a Randomised Clinical Pilot Study in Elderly Patients

University of Stuttgart2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2010年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
2
主要终点
Patient pain and disability

研究概览

简要总结

The therapy results after distal radius fracture especially of elderly patients are often suboptimal. The central problem results from the inevitable, 3-6-weeks immobilization, which leads to reduction in ROM of the wrist, deterioration of muscle strength as well as malfunction of fine motor skills and coordination. Currently, there are no adequate proactive strategies to counteract these immobilisation problems. Hence the overall aim of our research project is to investigate the therapeutic potential of a motor-cognitive therapy on hand function after distal radius fracture. On the one hand the pilot study should provide information about the level of recruitment rate necessitated for an adequate sample size which allows reliable evidence for the therapy effects. On the other hand we want to evaluate the sensitivity and adequacy of the assessment instruments.

The pilot is conceived as a controlled, randomised, longitudinal intervention study over 6 weeks with 3 groups. One experimental group imagine movements and actions without executing them. A second experimental group performs mirror training, in which visual feedback through a mirror activates additionally the contralateral hemisphere. The control group receives therapy as usual. There are three key domains to be analysed: function (PRWE), impairment (ROM, strength) and participation in social life/life quality (DASH, EQ5D).

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • wrist fracture
  • age 65 and older

排除标准

  • unstable medical conditions which preclude surgical intervention (ASA 5)
  • Patients who do not live independently (nursing home)
  • Patients with an open fracture
  • Associated soft tissue or skeletal injury to the same limb
  • Cognitive impairment (6CIT < 10)

结局指标

主要结局

Patient pain and disability

时间窗: 12 weeks

Patient Rated Wrist Evaluation (PRWE)

次要结局

  • objective measurements(12 weeks)
  • subjective hand function(12 weeks)
  • subjective well-being(12 weeks)

研究者

发起方
University of Stuttgart
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadja Schott

Professor

University of Stuttgart

研究点 (2)

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