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临床试验/NCT05911113
NCT05911113已完成不适用

Impact Of Sensory Re-Education Paradigm On Sensation And Quality Of Life In Patients Post-Covid 19 Polyneuropathy

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年6月26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
40
试验地点
1
主要终点
disability of life

研究概览

简要总结

This study will be conducted to investigate the effect of a sensory re-education paradigm on sensation and proprioception in patients with post covid-19 neuropathy.

详细描述

The Coronavirus disease has profoundly impacted the world, altering the functioning of the population and health system. it is so far affected more than 532 million cases and 6.3 million confirmed deaths (WHO., 2020). Recent studies documented that COVID-19-associated peripheral neuropathy is a common and frequent problem, with neuro-muscular complications. This phenomenon is widespread in those with comorbidities, such as diabetes mellitus, which may result from immune processes or as side effects of some medications used to manage COVID-19 symptoms, such as hydroxychloroquine, clindamycin, and steroids. To a lesser extent, prolonged hospitalization may cause entrapment neuropathy (peripheral nerve compression). Most physiotherapists focus on motor improvements rather than sensibility improvements though the sensory system may have the upper hand in improving motor function. Therefore; the sensory re-education paradigm should be assessed in randomized trials with a blinded assessment of functional outcomes to evaluate its effectiveness in patients with post covid-19 neuropathic patients. Currently, there is not enough research addressing the impact of the sensory re-education paradigm on sensation and quality of life in neuropathic patients post-covid19. forty patients will be assigned randomly into two equal groups; the study group will receive sensory re-education paradigm and traditional treatment while the control group will receive traditional treatment only.

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 (Participant, Outcomes Assessor)

盲法说明

opaque sealed envelope

入排标准

年龄范围
30 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients from both genders (male and female). The age of participants ranged from 30 to 40 years old. Participants were required to live in Egypt during the pre-covid and COVID-19 pandemic.
  • Patients with confirmation of previous covid19 infection PCR TEST. Patients meeting the guide line of world health organization (WHO) of long/post-covid 19 syndromes.
  • Patients with unknown prior neuropathy. Patients with neuropathy confirmed by EDX with a sensory nerve conduction velocity.

排除标准

  • Patients with Diabetes mellitus (DM), Rheumatology and Guillain-Barré syndrome (GBS).
  • Infection other than covid19 leading to sensory neuropathy. Traumatic or compressive lesions leading to central nervous system (CNS), peripheral nervous system (PNS) damages.
  • Previous surgeries or medications leading to neuropathy.

结局指标

主要结局

disability of life

时间窗: up to six weeks

disability of life will be measured using the Arabic, validated version of WHOQOL-BREF questionnaire. The scale consists of 26 items; the first two items address an individual's perception of his/her overall quality of life and health, respectively, and the remaining 24 items assess the four quality of life domains; Physical Health (seven items), Psychological (six items), Social Relationships (three items), and Environment (eight items). Each item is rated on a five-point Likert scale. The final scores were converted into a linear scale between 0 and 100 according to the scoring guidelines where higher scores indicate higher disability.

次要结局

  • Tactile sensation(up to six weeks)
  • hand grip strength(up to six weeks)
  • joint position error(up to six weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Younes Ali Khadour

principle investigator younes ali khadour

Cairo University

研究点 (1)

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