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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
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ".


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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

  4. 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.

  5. events/complications respiratory [ Time Frame: admission/discharge hospitalization - 3 months ]
    Relation between the presence of a diaphragmatic dysfunction and events / complications respiratory



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626558


Contacts
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Contact: Johan WORMSER +33 1 44 12 77 75 jwormser@hpsj.fr
Contact: Mathieu ZUBER, Pr +33 1 44 12 74 51 mzuber@hpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Hélène BEAUSSIER, PhD, PharmD    + 33 1 44 12 70 38    crc@hpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Publications of Results:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03626558    
Other Study ID Numbers: DISTROKE
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases