NCT05678816

Brief Summary

Stroke is the second major cause of death and disability worldwide with over 13 million new cases annually. Egypt, a low-middle-income country, is the most populated nation in the Middle East with a high overall crude prevalence rate of stroke (963/100,000 inhabitants), accounting for 6.4% of all deaths and the incidence of stroke annually is approximately 150,000-210,000. Stroke has a direct impact on health systems, resulting in high costs, and is also considered a global public health problem due to serious disabilities, functional limitations and compromised quality of life (QoL). The Breather a drug-free, evidence-based inspiratory/expiratory respiratory muscle training (RMT) device used by Dysphagia, COPD, CHF, Parkinson's, and neuromuscular disease patients, as well as children 4+ and adults interested in healthy aging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

September 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2022

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

December 4, 2022

Last Update Submit

January 7, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

  • forced expiratory volium in first second FEV1 in litres

    fifty patients will be assessed for their FEV1 using spirometer

    6 weeks

  • foced vital capacity FVC in litres

    fifty patients will be assessed for their FVC using spirometer

    6 weeks

  • peak inspiratory flow PIF in litres per second

    fifty patients will be assessed for their PIF using spirometer

    6 weeks

  • peak expiratory flow PEF in litres per second

    fifty patients will be assessed for their PEF using spirometer

    6 weeks

Secondary Outcomes (4)

  • Chest expansion in centimeters using tape measurement

    6 weeks

  • oxygen saturation in percentage using spirometer

    6 weeks

  • six minute walk distance in metersused to assess functional capacity of patients

    6 weeks

  • stroke impact scale to assess the effect of stroke on different domains astanderdized score ranging from 0 to 100 is calculated for all domains with higher score indicating a higher quality of life

    6 weeks

Study Arms (2)

BREATHER GROUP

EXPERIMENTAL

1)respiratory muscle training for inspiratory and expiratory muscles by the breather device 2)physiotherapy prgramme for stroke rehabilitation which include: * Passive stretching exercise, strengthening exercise. * Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing. * Gait training.

Device: BREATHEROther: physiotherapy prgramme for rehabilitation of stroke patients

CONTROL

OTHER

physiotherapy prgramme for stroke rehabilitation which include: * Passive stretching exercise, strengthening exercise. * Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing. * Gait training.

Other: physiotherapy prgramme for rehabilitation of stroke patients

Interventions

BREATHERDEVICE

respiratory muscle trainer used to strength inspiratory an expiratory muscles through breathing in and out against aresistence which is determined individually according to each patient.

BREATHER GROUP
physiotherapy prgramme for rehabilitation of stroke patientsOTHER

physiotherapy prgramme for rehabilitation of stroke patients which include: * Passive stretching exercise, strengthening exercise. * Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing. * Gait training.

BREATHER GROUPCONTROL

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Sixty patients were selected from both sexes.Their age were from 50 to 65 years old
  • All patients were medically stable.
  • All patients had the ability to understand and follow simple verbal instructions.
  • All patients were in subacute stage from about 3 to 6 months post lesion.

You may not qualify if:

  • Patients with severe acute illness.
  • Chronic unstable pulmonary and/or cardiac disease.
  • Impaired level of consciousness and evidence of gross cognitive problems.
  • Patients undergoes chemotherapy.
  • Active hemoptysis, untreated pneumothorax, recent esophageal surgery.
  • Recent oral, facial or skull trauma / surgery, acute sinusitis, epistaxis.
  • Smokers.
  • Any oral dysfunction that interfere with using the breather.
  • Un controlled BP systole more than180 or diastole more than 90.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University

Giza, Egypt

Location

Faculty of Phsical Therapy

Giza, Egypt

Location

Related Publications (4)

  • Lindsay MP, Norrving B, Sacco RL, Brainin M, Hacke W, Martins S, Pandian J, Feigin V. World Stroke Organization (WSO): Global Stroke Fact Sheet 2019. Int J Stroke. 2019 Oct;14(8):806-817. doi: 10.1177/1747493019881353. No abstract available.

    PMID: 31658892BACKGROUND

  • Aref H, Zakaria M, Shokri H, Roushdy T, El Basiouny A, El Nahas N. Changing the Landscape of Stroke in Egypt. Cerebrovasc Dis Extra. 2021;11(3):155-159. doi: 10.1159/000521271. Epub 2021 Dec 3.

    PMID: 34864736BACKGROUND

  • Krishnamurthi RV, Ikeda T, Feigin VL. Global, Regional and Country-Specific Burden of Ischaemic Stroke, Intracerebral Haemorrhage and Subarachnoid Haemorrhage: A Systematic Analysis of the Global Burden of Disease Study 2017. Neuroepidemiology. 2020;54(2):171-179. doi: 10.1159/000506396. Epub 2020 Feb 20.

    PMID: 32079017BACKGROUND

  • Gungen BD, Tunc A, Aras YG, Gundogdu AA, Gungen AC, Bal S. Predictors of intensive care unit admission and mortality in patients with ischemic stroke: investigating the effects of a pulmonary rehabilitation program. BMC Neurol. 2017 Jul 11;17(1):132. doi: 10.1186/s12883-017-0912-4.

    PMID: 28693521BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • NESREEN AL NAHAS, PROFESSOR

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigatort

Study Record Dates

First Submitted

December 4, 2022

First Posted

January 10, 2023

Study Start

September 15, 2022

Primary Completion

December 15, 2022

Study Completion

December 30, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations

EG(2)