AzTrials
AzTrials

StrokeDISTROKENCT03626558

Diaphragmatic Function Description in Stroke Patients

A study testing ultrasound measures in people with Stroke and Diaphragmatic Function, run by Fondation Hôpital Saint-Joseph.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Diaphragmatic Function
What is being tested?
ultrasound measures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
16 Jan 2020to 4 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

About this study

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.

Read more

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.

Read the 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.

Being tested
ultrasound measures
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasound measuresOther

    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.

Study groups in NCT03626558
Study groupRoleWhat they receive
Distroke patientsExperimentalFor 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.
Receives: Other: ultrasound measures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 ".

    Measured: admission/discharge hospitalization - 3 months

Secondary outcomes (5)

  1. 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).

    Measured: admission/discharge hospitalization - 3 months

  2. 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.

    Measured: admission/discharge hospitalization - 3 months

  3. the topography of the diaphragm dysfunction

    Description of the topography of the diaphragm dysfunction (unilateral, bilateral controlatarale injury) and brain damage

    Measured: admission/discharge hospitalization - 3 months

  4. 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.

    Measured: admission/discharge hospitalization - 3 months

  5. events/complications respiratory

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

    Measured: admission/discharge hospitalization - 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2018
  2. Study start16 Jan 2020
  3. Primary completion4 Oct 2020
  4. Study completion4 Oct 2020

Why it stopped: No participants were enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03626558
Sponsor's protocol ID
DISTROKE
Acronym
DISTROKE
Status last verified
Aug 2021
First submitted
8 Aug 2018
Last updated
20 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rabelo M, Nunes GS, da Costa Amante NM, de Noronha M, Fachin-Martins E. Reliability of muscle strength assessment in chronic post-stroke hemiparesis: a systematic review and meta-analysis. Top Stroke Rehabil. 2016 Feb;23(1):26-36. doi: 10.1179/1945511915Y.0000000008. Epub 2015 Aug 5.

    PubMed 26243549

  • Similowski T, Catala M, Rancurel G, Derenne JP. Impairment of central motor conduction to the diaphragm in stroke. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):436-41. doi: 10.1164/ajrccm.154.2.8756819.

    PubMed 8756819

  • Khedr EM, Trakhan MN. Localization of diaphragm motor cortical representation and determination of corticodiaphragmatic latencies by using magnetic stimulation in normal adult human subjects. Eur J Appl Physiol. 2001 Oct;85(6):560-6. doi: 10.1007/s004210100504.

    PubMed 11718285

  • 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.

    PubMed 22592740

  • 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.

    PubMed 27320833

  • Park GY, Kim SR, Kim YW, Jo KW, Lee EJ, Kim YM, Im S. Decreased diaphragm excursion in stroke patients with dysphagia as assessed by M-mode sonography. Arch Phys Med Rehabil. 2015 Jan;96(1):114-21. doi: 10.1016/j.apmr.2014.08.019. Epub 2014 Sep 16.

    PubMed 25234476

  • Jung KJ, Park JY, Hwang DW, Kim JH, Kim JH. Ultrasonographic diaphragmatic motion analysis and its correlation with pulmonary function in hemiplegic stroke patients. Ann Rehabil Med. 2014 Feb;38(1):29-37. doi: 10.5535/arm.2014.38.1.29. Epub 2014 Feb 25.

    PubMed 24639923

  • Voyvoda N, Yucel C, Karatas G, Oguzulgen I, Oktar S. An evaluation of diaphragmatic movements in hemiplegic patients. Br J Radiol. 2012 Apr;85(1012):411-4. doi: 10.1259/bjr/71968119. Epub 2011 Jun 28.

    PubMed 21712430

  • Cohen E, Mier A, Heywood P, Murphy K, Boultbee J, Guz A. Diaphragmatic movement in hemiplegic patients measured by ultrasonography. Thorax. 1994 Sep;49(9):890-5. doi: 10.1136/thx.49.9.890.

    PubMed 7940429

  • Houston JG, Morris AD, Grosset DG, Lees KR, McMillan N, Bone I. Ultrasonic evaluation of movement of the diaphragm after acute cerebral infarction. J Neurol Neurosurg Psychiatry. 1995 Jun;58(6):738-41. doi: 10.1136/jnnp.58.6.738.

    PubMed 7608679

  • de Almeida IC, Clementino AC, Rocha EH, Brandao DC, Dornelas de Andrade A. Effects of hemiplegy on pulmonary function and diaphragmatic dome displacement. Respir Physiol Neurobiol. 2011 Sep 15;178(2):196-201. doi: 10.1016/j.resp.2011.05.017. Epub 2011 Jun 6.

    PubMed 21679778

  • Kim M, Lee K, Cho J, Lee W. Diaphragm Thickness and Inspiratory Muscle Functions in Chronic Stroke Patients. Med Sci Monit. 2017 Mar 11;23:1247-1253. doi: 10.12659/msm.900529.

    PubMed 28284044

  • Gottesman E, McCool FD. Ultrasound evaluation of the paralyzed diaphragm. Am J Respir Crit Care Med. 1997 May;155(5):1570-4. doi: 10.1164/ajrccm.155.5.9154859.

    PubMed 9154859

  • Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

    PubMed 19017880

Questions about this trial

What is this clinical trial studying?

A study testing ultrasound measures in people with Stroke and Diaphragmatic Function, run by Fondation Hôpital Saint-Joseph.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The measures of the thickness and the fraction of thickening of the diaphragm (time frame: admission/discharge hospitalization - 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03626558, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in