Clinical trial NCT03626558: Diaphragmatic Function Description in Stroke Patients
Official title: Diaphragmatic Function Description in Stroke Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Diaphragmatic Function
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The measures of the thickness and the fraction of thickening of the diaphragm
timeFrame: admission/discharge hospitalization - 3 months
Secondary outcomes:
measure: The excursion of the diaphragm
timeFrame: admission/discharge hospitalization - 3 months
measure: Evolution of the excursion and the fraction of thickening of the diaphragm
timeFrame: admission/discharge hospitalization - 3 months
measure: the topography of the diaphragm dysfunction
timeFrame: admission/discharge hospitalization - 3 months
measure: National Institute of Health Stroke Score (NIHSS) and presence of diaphragm dysfunction
timeFrame: admission/discharge hospitalization - 3 months
measure: events/complications respiratory
timeFrame: admission/discharge hospitalization - 3 months
Other outcomes:
Locations:
Study officials:
References:
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