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Diaphragmatic Function Description in Stroke Patients

Diaphragmatic Function Description in Stroke Patients

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03626558
Acronym
DISTROKE
Enrollment
0
Registered
2018-08-13
Start date
2020-01-16
Completion date
2020-10-04
Last updated
2021-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragmatic Function, Stroke

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.

Interventions

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.

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The measures of the thickness and the fraction of thickening of the diaphragmadmission/discharge hospitalization - 3 monthsThe 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

MeasureTime frameDescription
The excursion of the diaphragmadmission/discharge hospitalization - 3 monthsThe 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 diaphragmadmission/discharge hospitalization - 3 monthsEvolution 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 dysfunctionadmission/discharge hospitalization - 3 monthsDescription 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 dysfunctionadmission/discharge hospitalization - 3 monthsRelation 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 respiratoryadmission/discharge hospitalization - 3 monthsRelation between the presence of a diaphragmatic dysfunction and events / complications respiratory

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026