Diaphragmatic Function Description in Stroke Patients (DISTROKE)

Fondation Hôpital Saint-Joseph

Status: Withdrawn

Conditions: Stroke; Diaphragmatic Function

Treatments: Other: ultrasound measures

Study type: Interventional

Funder types: Other

Identifiers

NCT03626558

DISTROKE

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Distroke patients

Experimental group

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.

Treatment:

Other: ultrasound measures