跳至主要内容
临床试验/NCT04467255
NCT04467255招募中不适用

Muscular Fatigue Evaluation in Patients With Diabetic Neuropathy by Means of Multichannel Surface Electromyography After a Rehabilitative Training: Aerobic Versus Endurance Training.

Istituti Clinici Scientifici Maugeri SpA2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Six-minute walk test

研究概览

简要总结

Fatigue in diabetic neuropathy compromises patients' physical activity and poses questions on how to plan correct rehabilitation training. Conclusive interpretation of muscular mechanisms of fatigue in diabetic neuropathy has not yet been achieved. Among the various instrumental evaluations for fatigue, multichannel surface electromyography (sEMG) is a recognized tool that permits the study of myoelectric manifestations of fatigue. Aim of the study is to assess if differences in myoelectric manifestations of fatigue between patients affected by diabetic neuropathy exist after an aerobic or endurance training.

详细描述

The instrumental session consisted of the registration of sEMG signals during electrically stimulated and voluntary contractions according to a consolidated standardized protocol. The investigated muscle is the Anterior Tibial.

Each subjects sat comfortably on a chair with his/her ankle flexed at 90° degree and knee extended; the leg was fixed at 90 degrees, in the isometric brace fixed on a plane (MISO1, LISiN Bioengineering Centre, Turin Polytechnic, Italy Torque was measured with a modular brace incorporating two independent torque transducers (model TR11, CCT Transducers, Torino, Italy).

The signal from the two torque meters were amplified, summed and displayed by means of a visual feedback system, which provided the subject with information regarding the torque level produced. Torque signal were stored to be analysed later.

The sEMG signal of the right Anterior Tibial was investigated with a flexible adhesive linear array of 16 electrodes (silver bars 10 mm long, 1 mm diameter, 10 mm apart) in single differential (SD) configuration. The optimal position and orientation of the array was determined at moderate contraction levels by visual inspection of the signal. It provided clear motor unit action potentials with similar propagation in the two directions from the neuromuscular junction to the tendons.

The reference electrode was positioned on the patient's leg. The skin was cleaned by slightly abrading it with abrasive gel before positioning the array.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Michigan Neuropathy Screening instrument higher or equal to 7
  • Stable clinical conditions

排除标准

  • Other neurological conditions or diseases
  • Skin lesions
  • Recent lower limb fractures or lower limb surgical intervention

结局指标

主要结局

Six-minute walk test

时间窗: 4 weeks

The score of the test is the distance a patient walks in 6 minutes measured in meters.

次要结局

  • Functional Independence Measure(4 weeks)
  • Modified Borg Scale(4 weeks)
  • Surface multichannel electromyographic variables.(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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