跳至主要内容
临床试验/NCT00498758
NCT00498758Unknown2 期

The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 60 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
2 期
入组人数
60
主要终点
gait characteristics

研究概览

简要总结

The purpose of this study is to evaluate the benefits of a biomechanical wedge system - The APOS system, for improving the stability of gait, mobility and quality of life in Parkinson's disease patients.

详细描述

Recently, a biomechanical wedge system was developed for gait and balance training among patients suffering from gait disorders. The APOS system (APOS Medical & Sports Technologies Ltd, Hertzeliya, Israel) applies special semispherical shoes, with individually adjusted implants, to improve age- and disease-related loss in muscle strength and neuromuscular control. The semispherical rubber devices that are placed on the soles of the shoes at the hind-foot and mid-foot can be moved medially, laterally, forwards and backwards. The system can be individually adjusted in order to optimally balance loading and re-train postural control during gait. An additional advantage of this treatment approach is the extraordinary compliance. The system is easily adjusted, maintained, and allows safe gait training.

After randomization, all subjects will be fitted with the APOS system, These shoes alter the dynamic balance during all gait cycle phases, adjusting the center of gravity and training postural control.

The precise location of the two wedges is adjusted individually by expert trainers using standardized protocols. Subjects in the intervention group will receive a proper wedge; subjects in the sham group will receive an almost flat wedge that lacks the proper biomechanical characteristics. However, both shoes and wedges will look similar. All subjects will be instructed to start gradually, with a goal of reaching 30 minutes of in-home walking while wearing the special training shoes. As an extra pre-caution, all subjects will be asked to walk with the shoes only in the presence of a caregiver, spouse or other family member during the first month. Before moving to more independent training, subjects will be checked for safety.

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

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic Parkinson's disease
  • Stage 2-3 Hoehn & Yahr

排除标准

  • Peripheral neuropathic pain
  • Severe orthopaedic condition
  • Hearing or vision loss
  • Usage of walking aid

结局指标

主要结局

gait characteristics

时间窗: 3 monthes

Quality of life

时间窗: 3 monthes

Mobility

时间窗: 3 monthes

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

相似试验