Effect Of Breather On Pulmonary And Physical Function In Post Stroke Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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Stroke is a leading cause of death and disability in globally and particularly in low and middle-income countries, and this burden is increasing.

The expected spontaneous biological recovery follows the "proportional recovery rule" - most patients recover 70% of their impaired motor or verbal function during the first three months after stroke however, 90% of them have residual deficit.

Stroke patients may experience a reduction of up to 50% in respiratory function when compared to age- and gender-matched norms. The reduction in respiratory function can lead to decreased endurance, dyspnea and increased sedentary behaviour, as well as an elevated risk of recurrent stroke. The reduction in respiratory function may also cause aspiration, leading to pneumonia. Previous research showed that pneumonia was an independent risk factor for mortality and a poor prognosis in stroke patients. Research also showed that a reduction in respiratory muscle and abdominal muscle strength contributed to pulmonary and respiratory dysfunction following a stroke.

After a stroke, the respiratory center and related motor pathways can directly decrease respiratory muscle strength and subsequently induce a change in breathing patterns. As a result, pneumonia, pulmonary ventilation disorders, lung injury, lung ischemia reperfusion injury, decreased pulmonary compliance, abnormal posture, and obstructive sleep apnea can occur following a stroke. Thus, pulmonary rehabilitation is critical to reducing these complications. The main forms of pulmonary rehabilitation include exercise training, respiratory muscle training, oxygen therapy, noninvasive ventilation, nutrition support, social psychological support, and health education.

The inspiratory muscles can be specifically trained, with improvement of both muscle strength and endurance by using the breather device.

As result utilizing the breather may help stroke patients recover quickly and avoid respiratory complication.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BREATHER GROUP

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.

Group Type EXPERIMENTAL

BREATHER

Intervention Type DEVICE

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.

physiotherapy prgramme for rehabilitation of stroke patients

Intervention Type OTHER

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.

CONTROL

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.

Group Type OTHER

physiotherapy prgramme for rehabilitation of stroke patients

Intervention Type OTHER

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.

Interventions

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BREATHER

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.

Intervention Type DEVICE

physiotherapy prgramme for rehabilitation of stroke patients

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No