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临床试验/NCT03626558
NCT03626558撤回不适用

Diaphragmatic Function Description in Stroke Patients

Fondation Hôpital Saint-Joseph0 个研究点开始时间: 2020年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
The measures of the thickness and the fraction of thickening of the diaphragm

研究概览

简要总结

Stroke is the leading cause of adult disability throughout the world. Motor function deficit is one of the common consequences. It is usually described for the peripheral muscles that there is a cortical representation contralaterale with a crossed cortico-spinal route: the consequence is a contralaterale motor disorder on the brain damage.

The impact of a stroke on diaphragm movements have been described in 6 studies: however, they were all observational and transversal studies evaluating diaphragm function.

Assessment using diaphragm thickness is another technique described in the literature. Visualization of diaphragm in the zone of apposition allows to assess diaphragm thickness at inspiration and expiration. The impact of a stroke on diaphragm thickening has been reported in only one recent observational study.

It seems that diaphragm would be damaged after a stroke, but unilateral or bilateral dysfonction is yet to be confirmed. Moreover, only a few measurements were performed in these studies, and not a diaphragm function follow-up.

详细描述

To our knowledge, no longitudinal study evaluated diaphragm movements and diaphragm thickness fraction. This study is a preliminary study which aims to evaluate diaphragm function after a stroke and its evaluation within the first months.

Starting hypothesis is the following: after a stroke, patients with a unilateral motor dysfunction have a diaphragm dysfunction predominant on the same side as the motor dysfunction. After a few months, retrieval is insufficient and they could benefit from a specific reinforcement program.

研究设计

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

入排标准

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

入选标准

  • •Men and women (age ≥ 18 years), hospitalized in the neuro-vascular or neurology department of the Groupe hospitalier Paris Saint-Joseph
  • •First episode of ischemic or hemorrhagic stroke diagnosed in the imaging and responsible for a unilateral motor deficit
  • •Minimum National Institute of Health Stroke Score of 5 for the total of items 4, 5 and 6 (paralysis facial and functioning of upper and lower limbs)
  • •Patient with medical insurance
  • •Francophone

排除标准

  • •History of neuromusclar pathology
  • •History of severe chronic respiratory pathology
  • •Malformation, chronic lesion or surgery of the diaphragm
  • •Recent thoracic and abdominal surgery
  • •National Institute of Health Stroke Score > 20
  • •Limiting health care or life support patient
  • •Impossibility to understand and to make simple orders (whatever is the cause: change of consciousness, cognitive disorders, aphasias, etc...)
  • •Major handicap before stroke (Rankin modified score)
  • •Refusal to participate in the study
  • •Patient under guardianship or curatorship
  • •Patient deprived of liberty

研究组 & 干预措施

Distroke patients

Experimental

For every patient include in the study, ultrasound measures at the admission/discharge of hospitalization will be realized.

All the patients will see each other suggested participating in a new collection of remote ultrasound measures of the stroke (around 2-3 months). These measures will be made during the usual consultation proposed by the department of neurology. This medical consultation is a part of the follow-up post--stroke recommended by the High Authority of Health. These measures will allow us to highlight the kinetics of recovery of the diaphragmatic function except any intervention of reeducation of muscles inspirers.

干预措施: ultrasound measures (Other)

结局指标

主要结局

The measures of the thickness and the fraction of thickening of the diaphragm

时间窗: admission/discharge hospitalization - 3 months

The measures of the thickness and the fraction of thickening of the diaphragm will be qualitatively described on the basis of the data of Gottesman: dysfunction of the diaphragm " yes/no ".

次要结局

  • Evolution of the excursion and the fraction of thickening of the diaphragm(admission/discharge hospitalization - 3 months)
  • events/complications respiratory(admission/discharge hospitalization - 3 months)
  • National Institute of Health Stroke Score (NIHSS) and presence of diaphragm dysfunction(admission/discharge hospitalization - 3 months)
  • The excursion of the diaphragm(admission/discharge hospitalization - 3 months)
  • the topography of the diaphragm dysfunction(admission/discharge hospitalization - 3 months)

研究者

申办方类型
Other
责任方
Sponsor

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