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临床试验/NCT01856244
NCT01856244已完成1 期

Sensorimotor Treadmill Training to Improve Gait and Balance in Parkinson's Disease

University of Erlangen-Nürnberg2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Change from Baseline Gait Speed

研究概览

简要总结

Persons with Morbus Parkinson commonly develop gait and balance disorders leading to dependence, loss of mobility and a high risk of falling.

This study investigates the effectiveness of a sensorimotor treadmill intervention to improve walking and balance abilities in persons with early stages of Parkinson's disease. The sensorimotor treadmill training is conducted on a special treadmill device which is challenging the participants by small oscillations. This intervention, which is supposed to simulate walking on natural, uneven surfaces, is compared to a conventional treadmill training.

Hypothesis: Sensorimotor treadmill training leads to larger improvements in walking and balance abilities as compared to conventional treadmill exercise.

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

入选标准

  • Parkinson's disease stage 1-3 Hoehn and Yahr
  • United Parkinson Disease Rating Scale (UPDRS) 'gait' or 'postural stability' subscore of 1 or more
  • Ability to stand unaided and walk without an assistive device
  • Stable medication during the study period

排除标准

  • On-off and wearing-off phenomena
  • Unstable medical or psychiatric illness
  • Clinically relevant cardiovascular or orthopaedic disease
  • Severe polyneuropathy
  • Cognitive impairment

结局指标

主要结局

Change from Baseline Gait Speed

时间窗: 8 weeks and 20 weeks

Self selected walking speed is assessed on a 10 meter walk distance

Change from Baseline Balance

时间窗: 8 weeks and 20 weeks

Mini - Balance Evaluation Systems Test (Mini - BESTest), Postural Sway in the Romberg Test with eyes open and eyes closed for 30 seconds

次要结局

  • Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS)(8 weeks and 20 weeks)
  • Change from Baseline Gait Performance(8 weeks and 20 weeks)
  • Change from Baseline Mobility(8 weeks and 20 weeks)

研究者

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

Prof. Dr. Klaus Pfeifer

Prof. Dr.

University of Erlangen-Nürnberg

研究点 (2)

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