NCT03626558

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable stroke

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 16, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2020

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

August 8, 2018

Last Update Submit

August 19, 2021

Conditions

StrokeDiaphragmatic Function

Outcome Measures

Primary Outcomes (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 ".

    admission/discharge hospitalization - 3 months

Secondary Outcomes (5)

  • The excursion of the diaphragm

    admission/discharge hospitalization - 3 months

  • Evolution of the excursion and the fraction of thickening of the diaphragm

    admission/discharge hospitalization - 3 months

  • the topography of the diaphragm dysfunction

    admission/discharge hospitalization - 3 months

  • National Institute of Health Stroke Score (NIHSS) and presence of diaphragm dysfunction

    admission/discharge hospitalization - 3 months

  • events/complications respiratory

    admission/discharge hospitalization - 3 months

Study Arms (1)

Distroke patients

EXPERIMENTAL

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.

Other: ultrasound measures

Interventions

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.

Distroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 26243549RESULT

  • 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.

    PMID: 8756819RESULT

  • 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.

    PMID: 11718285RESULT

  • 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.

    PMID: 22592740RESULT

  • 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.

    PMID: 27320833RESULT

  • 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.

    PMID: 25234476RESULT

  • 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.

    PMID: 24639923RESULT

  • 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.

    PMID: 21712430RESULT

  • 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.

    PMID: 7940429RESULT

  • 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.

    PMID: 7608679RESULT

  • 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.

    PMID: 21679778RESULT

  • 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.

    PMID: 28284044RESULT

  • 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.

    PMID: 9154859RESULT

  • 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.

    PMID: 19017880RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 13, 2018

Study Start

January 16, 2020

Primary Completion

October 4, 2020

Study Completion

October 4, 2020

Last Updated

August 20, 2021

Record last verified: 2021-08