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临床试验/NCT00637546
NCT00637546已完成2 期

Efficacy of a Specific Physiotherapy Group Treatment on Gait and Balance in Patients With Diabetic Neuropathy

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
71
试验地点
2
主要终点
Gait parameter: comfortable speed

研究概览

简要总结

Type 2 diabetes is one of the fastest growing public health problems in both developed and developing countries. It is estimated that the number of people with diabetes in the world will double in coming years, from 171 million in 2000 to 366 million in 2030.The role of physiotherapy in diabetic care is to reduce immobilisation effects, to maintain functional capacity and to minimise diabetes-related complications. The physiotherapist also has a role in providing advice about exercise and daily living activities. The fundamental principle of rehabilitation is to improve quality of life while diminishing the health care burden. By reducing the heightened risk of falling, the fall related injuries and the fear of falling one could improve quality of life in diabetic patients and reduce health care costs.

The goal of this study is to investigate the effectiveness of gait and balance training in pre frail subgroup diabetes patients. Our program is based on recommendations of Robertson et al.(2002) and Page et al.(2002) The investigators randomly assign patients in a control group (no treatment) or in a treatment group. The treatment program consists of two group sessions per week over 12 weeks. Patients were encouraged to perform specific home exercises. After this 12-week program, patients were asked to continue their exercises. The effect of the treatment will be evaluated after the treatment program and after a 6-month follow up.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Past or present patient from the University Hospital in Geneva
  • Diagnosed with diabetes by the medical doctor (glycaemia > 7 mmol on two different tests on an empty stomach)
  • Presence of a peripheral neuropathy (vibration perception ≤ 4)

排除标准

  • Patients with a foot ulcer at the moment of intake
  • Patients with orthopaedic or chirurgical problems influencing gait parameters
  • Patients with a non diabetic neuropathy (Charcot, alcohol, Thyroid dysfunction)
  • Patients with neurological problems influencing gait parameters
  • Patients with incapacity to walk without a walking aid

结局指标

主要结局

Gait parameter: comfortable speed

时间窗: Before treatment / After treatment / 6 month follow up

次要结局

  • Fear of falling (Falls efficacy scale)(Before Treatment / After Treatment / 6 month follow up)
  • Other spatio temporal gait parameters and sagittal movement of lower limb(Before Treatment/ After Treatment/ 6 month follow up)
  • Balance measures (Tinetti and Biodex balance Index, acceleration on sacrum)(Before Treatment / After Treatment / 6 month follow up)

研究者

申办方类型
Other

研究点 (2)

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