Diaphragmatic Function Description in Stroke Patients (DISTROKE)
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|ClinicalTrials.gov Identifier: NCT03626558|
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : February 6, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Diaphragmatic Function||Other: ultrasound measures||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diaphragmatic Function Description in Stroke Patients|
|Actual Study Start Date :||January 16, 2020|
|Estimated Primary Completion Date :||January 16, 2021|
|Estimated Study Completion Date :||March 31, 2021|
Experimental: Distroke patients
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.
Other: ultrasound measures
It is three diaphragmatic ultrasounds measures of a duration of twenty minutes each approximately. The diaphragmatic ultrasound is practised by trans-thoracic way and is non-invasive, completely painless and does not require the exposure of patients to radiation.
- The measures of the thickness and the fraction of thickening of the diaphragm [ Time Frame: 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 ".
- The excursion of the diaphragm [ Time Frame: admission/discharge hospitalization - 3 months ]The excursion of the diaphragm, on the basis of the data of Boussuges will be qualitatively described (dysfunction of the diaphragm: yes/no).
- Evolution of the excursion and the fraction of thickening of the diaphragm [ Time Frame: admission/discharge hospitalization - 3 months ]Evolution of the excursion and the fraction of thickening of the diaphragm enters the day of the stroke and 2-3 months after stroke. The measure of the excursion of the diaphragm and that of the thickening will be quantitatively described.
- the topography of the diaphragm dysfunction [ Time Frame: admission/discharge hospitalization - 3 months ]Description of the topography of the diaphragm dysfunction (unilateral, bilateral controlatarale injury) and brain damage
- National Institute of Health Stroke Score (NIHSS) and presence of diaphragm dysfunction [ Time Frame: admission/discharge hospitalization - 3 months ]Relation between the National Institute of Health Stroke Score (minimum score = 20, maxium score = 40, clinical stroke score for stroke with prognostic and therapeutic implications) and the presence of a diaphragmatic dysfunction. An NIHSS score between 1 and 4 means a minor stroke, between 5 and 15, a moderate stroke, between 15 and 20, severe, and above 20 points, a severe stroke.
- events/complications respiratory [ Time Frame: admission/discharge hospitalization - 3 months ]Relation between the presence of a diaphragmatic dysfunction and events / complications respiratory
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626558
|Contact: Johan WORMSER||+33 1 44 12 77 email@example.com|
|Contact: Mathieu ZUBER, Pr||+33 1 44 12 74 firstname.lastname@example.org|
|Groupe Hospitalier Paris Saint-Joseph||Recruiting|
|Paris, France, 75014|
|Contact: Hélène BEAUSSIER, PhD, PharmD + 33 1 44 12 70 38 email@example.com|