Stroke Clinical Trial
Official title:
Effects of a Home-based Respiratory Muscle Training on Swallowing Function in Patients With Chronic Stroke
NCT number | NCT06312319 |
Other study ID # | DF0001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 20, 2023 |
Est. completion date | June 20, 2024 |
The aim of this study is to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive a home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 20, 2024 |
Est. primary completion date | March 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Clinical diagnosis of stroke - 18 years of age or more Exclusion Criteria: - Cognitive impairment or aphasia that prevents the understanding of instructions. - Tracheostomy. - Presence of cancer. - Patients who present another disease of the central nervous system - Absence of neuromotor competence to carry out the respiratory function tests. - Central apnea. - Hypoventilation-obesity syndrome. - Severe cardiorespiratory impairment (hemodynamic instability, pulmonary embolism, recent pneumonothorax, acute hemoptysis, active respiratory infections, recent myocardial infarction, unstable angina, pulmonary hypertension, uncontrolled asthma, or severe chronic obstructive pulmonary disease). - Patients with recent otorhinolaryngological, abdominal, or thoracic surgery. |
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Health Sciences | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gugging Swallowing screen | Screening test that indicates the need to evaluate the presence of dysphagia. The scores ranges from 0 to 20, with higher scores indicating better performance. Twenty points are the highest score that a patient can attain, and it means normal swallowing ability without aspiration risk. | Baseline, 6 weeks | |
Primary | Swallowing quality of life questionnaire | Questionnaire evaluating the impact of swallowing deficits on daily living. The scores range from 0 to 100 metric, with a lower score indicating less quality of life. | Baseline, 6 weeks | |
Primary | cough peak flow | Evaluation of the strength of cough using a peak flow meter | Baseline, 6 weeks | |
Secondary | Forced vital capacity | This is the maximum amount of air you can forcibly exhale from your lungs after fully inhaling | Baseline, 6 weeks | |
Secondary | Forced expiratory volumen in the first second | refers to the volume of air that an individual can exhale during a forced breath in the first second. | Baseline, 6 weeks | |
Secondary | FEV1/FVC ratio | This is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs | Baseline, 6 weeks | |
Secondary | Respiratory Pressure Meter | This measure will include the maximal inspiratory and maximal expiratory measures evaluated using a device | Baseline, 6 weeks |
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