跳至主要内容
临床试验/NCT05693207
NCT05693207招募中不适用

EMG to Detect and Monitor Freezing of Gait Among People With Parkinson's Disease

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Percentage time of co-contractions

研究概览

简要总结

The main goal of this study is to evaluate, via EMG (electromyography) system, the muscle activity in the lower limbs, to understand the contribution of the muscle activity to FOG (freezing of gait) in Parkinson's patients. The phenomenon of FOG appears in advanced cases of Parkinson's disease (PD) and can lead to an increased risk of falls. There are several approaches claiming that there is abnormal activity in the calf muscles and the freezing events in Parkinson's patients. In the clinic, monitoring FOG is done subjectively, usually through observations or through questionnaires. As a result, the information about the phenomenon may be biased and insensitive. With an electromyographic monitor (EMG), objective information about the muscular activity during normal walking and during unusual events can be obtained.

详细描述

The subject will arrive independently at the Tel Aviv Medical Center. After explaining the course of the study and signing a consent form, the subject will be administered the MoCA questionnaire to assess the cognitive state.

During this session, the patient will undergo gait evaluation using motion sensors and an EMG device.

This meeting will last up to an hour, according to the following breakdown:

Explanation of the test (10 min) Preparing the skin (light disinfection with alcohol) for EMG adhesion (10 min.) Performing of the test (20 minutes) Summary and discharge (5 min).

研究设计

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

入排标准

年龄范围
40 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for patients:
  • •Men and women aged 40-
  • •Patients with idiopathic Parkinson's disease according to the diagnosis of a neurologist, who are able to walk with or without a walking aid for at least 5 minutes.
  • •21 or above in MoCA test.
  • •people who gave their written and oral consent to participate in the study.
  • •Inclusion criteria for healthy people:
  • •Men and women aged 40-
  • •24 or above in MoCA test.
  • •Without a neurological, cardiovascular or orthopedic disorder, which could affect the normal walking pattern, and all within the researcher's decision.
  • •Criteria for exclusion from the experiment:
  • •The patient has serious side effects that are not suitable for continuing in the study.
  • •The patient does not wish to continue his participation in the study.

排除标准

  • •for Parkinson's patients:
  • •Neurological or other psychiatric disorder (such as MSA, PSP, after a stroke with neurological signs, dementia diseases, clinical depression) at the researcher's decision.
  • •History of head injury - traumatic brain injury or cerebrovascular accident (CVA)
  • •This study will not include pregnant women and children.

研究组 & 干预措施

People with iPD with freezing of gait

Experimental

干预措施: EMG (Device)

People with iPD without freezing of gait

Other

control group

干预措施: EMG (Device)

结局指标

主要结局

Percentage time of co-contractions

时间窗: 60 minutes

The time of co-contraction during walking will be higher among people with FOG.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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