Effects of Motor Cognitive Training on Functional Loss Through Immobilization After Osteoporotic Distal Radius Fractures: a Randomised Clinical Pilot Study in Elderly Patients
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
- 否
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
Nadja Schott
Professor
University of Stuttgart
