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Diaphragmatic Function Description in Stroke Patients (DISTROKE)

Primary Purpose

Stroke, Diaphragmatic Function

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound measures
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Distroke patients

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    The excursion of the diaphragm
    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
    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
    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
    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
    Relation between the presence of a diaphragmatic dysfunction and events / complications respiratory

    Full Information

    First Posted
    August 8, 2018
    Last Updated
    August 19, 2021
    Sponsor
    Fondation Hôpital Saint-Joseph
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03626558
    Brief Title
    Diaphragmatic Function Description in Stroke Patients
    Acronym
    DISTROKE
    Official Title
    Diaphragmatic Function Description in Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants were enrolled.
    Study Start Date
    January 16, 2020 (Actual)
    Primary Completion Date
    October 4, 2020 (Actual)
    Study Completion Date
    October 4, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondation Hôpital Saint-Joseph

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Diaphragmatic Function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Distroke patients
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    ultrasound measures
    Intervention Description
    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 Measure Information:
    Title
    The measures of the thickness and the fraction of thickening of the diaphragm
    Description
    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 ".
    Time Frame
    admission/discharge hospitalization - 3 months
    Secondary Outcome Measure Information:
    Title
    The excursion of the diaphragm
    Description
    The excursion of the diaphragm, on the basis of the data of Boussuges will be qualitatively described (dysfunction of the diaphragm: yes/no).
    Time Frame
    admission/discharge hospitalization - 3 months
    Title
    Evolution of the excursion and the fraction of thickening of the diaphragm
    Description
    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.
    Time Frame
    admission/discharge hospitalization - 3 months
    Title
    the topography of the diaphragm dysfunction
    Description
    Description of the topography of the diaphragm dysfunction (unilateral, bilateral controlatarale injury) and brain damage
    Time Frame
    admission/discharge hospitalization - 3 months
    Title
    National Institute of Health Stroke Score (NIHSS) and presence of diaphragm dysfunction
    Description
    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.
    Time Frame
    admission/discharge hospitalization - 3 months
    Title
    events/complications respiratory
    Description
    Relation between the presence of a diaphragmatic dysfunction and events / complications respiratory
    Time Frame
    admission/discharge hospitalization - 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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    Citation
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    PubMed Identifier
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    Citation
    Xiao Y, Luo M, Wang J, Luo H. Inspiratory muscle training for the recovery of function after stroke. Cochrane Database Syst Rev. 2012 May 16;2012(5):CD009360. doi: 10.1002/14651858.CD009360.pub2.
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    PubMed Identifier
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    Citation
    Menezes KK, Nascimento LR, Ada L, Polese JC, Avelino PR, Teixeira-Salmela LF. Respiratory muscle training increases respiratory muscle strength and reduces respiratory complications after stroke: a systematic review. J Physiother. 2016 Jul;62(3):138-44. doi: 10.1016/j.jphys.2016.05.014. Epub 2016 Jun 16. Erratum In: J Physiother. 2018 Mar 22;:
    Results Reference
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    PubMed Identifier
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    Citation
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