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临床试验/NCT06160336
NCT06160336已完成不适用

Use of Transcutaneous Electrical Stimulation for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees

Fondazione Don Carlo Gnocchi Onlus1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Electrical Sensation Mapping Questionnaire

研究概览

简要总结

Current lower limb prostheses support ambulation by absorbing and stabilizing positions during walking. Users of lower limb prostheses rely solely on sensory information provided by the contact between the socket and the residual limb. Restoring sensory feedback could potentially improve their quality of life and participation in daily activities. Despite a high incidence of lower limb amputations, there are few studies in the literature addressing the restoration of sensory feedback in lower limb amputees, particularly studies utilizing invasive techniques. In an effort to overcome these limitations, various non-invasive methods have been tested. Despite resulting benefits such as improved gait symmetry and stability, most non-invasive stimulation systems are non-somatotopic, failing to generate a sensation referred to the patient's missing limb. From the literature, Transcutaneous Electrical Nerve Stimulation (TENS) emerges as a very promising non-invasive and somatotopically-based sensory feedback approach, capable of inducing sensations referred to the amputees' phantom limb.

Therefore, the proposed study will involve the use of TENS as a means to stimulate sensitivity and prevent perceptual disturbances associated with the interruption of peripheral nerve structures occurring in individuals undergoing amputation. These disturbances, besides influencing the development of symptoms characterized by neuropathic pain, can impact prosthesis management.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • age between 18 and 80 years;
  • unilateral transtibial amputation or transfemoral amputation at least two months prior the study;
  • stable clinical conditions;
  • skin integrity;
  • absence of cognitive deficits.

排除标准

  • bilateral amputation;
  • open wounds or sores on the residual limb;
  • cognitive deficits;
  • presence of implanted medical device (e.g., cardiac defibrillators, pacemakers or infusion pumps);
  • refusal to sign the informed consent.

结局指标

主要结局

Electrical Sensation Mapping Questionnaire

时间窗: Baseline

It is an ad-hoc questionnaire designed for comprehensive characterization of sensations elicited through TENS. This includes perceptual thresholds, referred sensations (evaluated for naturalness, depth, pain, intensity, and quality), sensitivity, size, and similarity of the activated areas. The questionnaire incorporates: a five-point scale assessing naturalness from unnatural to natural, a metric to determine the sensation's location (i.e., superficial and/or deep), a scale from 0 to 10 measuring the intensity and pain levels of the sensation, and multiple choice options to describe the quality (touch/pressure, pinch, vibration, tugging, tingling, burning, hot, cold, ankle flexion, ankle extension, toe flexion, toe extension, and none)

次要结局

  • Changes in gait symmetry(Baseline; after a 1-month intervention)
  • Changes in body weight distribution between legs during gait(Baseline; after a 1-month intervention)
  • Changes in Pain Intensity (NRS)(Baseline; after a 1-month intervention)
  • Changes in Neuropathic Pain (NPSI)(Baseline; after a 1-month intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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