StrokeNCT06312319
Home-based Respiratory Training on Swallowing in Stroke
A study testing Respiratory training and Orofacial exercises in people with Stroke, run by Universidad de Granada at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Respiratory training and Orofacial exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 20 Aug 2023to 20 Jun 2024
- 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
- Clinical diagnosis of stroke
- 18 years of age or more
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Irene Cabrera Martos contact
Spain1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences
Granada, 18016
Irene Cabrera Martos, irenecm@ugr.es
About this study
Official title: Effects of a Home-based Respiratory Muscle Training on Swallowing Function in Patients With Chronic Stroke
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.
Read the detailed description
This study aims 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 home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment. The swallowing function will be assessed using specific tools and questionnaires. Secondary outcomes will evaluate the respiratory function. The intervention will have a duration of 6 weeks.
- Conditions
- Stroke
- Being tested
- Respiratory training, Orofacial exercises
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory trainingDevice
Respiratory training using the EMST 150 device to increase inspiratory and expiratory muscle strength.
Orofacial exercisesOther
The exercises will include activities to improve orofacial structures such as mobility, strength and coordination.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory training added to orofacial exercises | Experimental | Home-based respiratory training of the inspiratory and expiratory muscles using a device added to standard treatment including orofacial exercises. Receives: Device: Respiratory training; Other: Orofacial exercises |
| Orofacial exercises | Active comparator | Standard treatment including orofacial exercises. Receives: Other: Orofacial exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
cough peak flow
Evaluation of the strength of cough using a peak flow meter
Measured: Baseline, 6 weeks
Secondary outcomes (4)
Forced vital capacity
This is the maximum amount of air you can forcibly exhale from your lungs after fully inhaling
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
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
Measured: Baseline, 6 weeks
Respiratory Pressure Meter
This measure will include the maximal inspiratory and maximal expiratory measures evaluated using a device
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start20 Aug 2023
- Primary completion20 Mar 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Cabrera Martos, Universidad de Granada
- Investigators
- Irene Cabrera Martos, Principal investigator, UGR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312319
- Sponsor's protocol ID
- DF0001
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home-based Respiratory Muscle Training on Swallowing Function in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06312319
- Acronym / sponsor ID
- DF0001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims 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 home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment. The swallowing function will be assessed using specific tools and questionnaires. Secondary outcomes will evaluate the respiratory function. The intervention will have a duration of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory training added to orofacial exercises | Experimental | Device: Respiratory training, Other: Orofacial exercisesHome-based respiratory training of the inspiratory and expiratory muscles using a device added to standard treatment including orofacial exercises. |
| Orofacial exercises | Active comparator | Other: Orofacial exercisesStandard treatment including orofacial exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of stroke
- 18 years of age or more
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory trainingRespiratory training using the EMST 150 device to increase inspiratory and expiratory muscle strength. | Device | Respiratory training added to orofacial exercises |
| Orofacial exercisesThe exercises will include activities to improve orofacial structures such as mobility, strength and coordination. | Other | Orofacial exercises, Respiratory training added to orofacial exercises |
Primary outcome
Gugging Swallowing screen
Time frame: Baseline, 6 weeks
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.
Swallowing quality of life questionnaire
Time frame: Baseline, 6 weeks
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.
cough peak flow
Time frame: Baseline, 6 weeks
Evaluation of the strength of cough using a peak flow meter
4 secondary outcomes
Forced vital capacity
Time frame: Baseline, 6 weeks
Forced expiratory volumen in the first second
Time frame: Baseline, 6 weeks
FEV1/FVC ratio
Time frame: Baseline, 6 weeks
Respiratory Pressure Meter
Time frame: Baseline, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Related trials for Stroke
Recruiting
The AHA Oneida Study
Oneida Nation Members
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Active, not recruiting
Brain Connectivity Analysis
Neural Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Cabrera Martos contact
Irene Cabrera Martos principal investigator
UGR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory training and Orofacial exercises in people with Stroke, run by Universidad de Granada at 1 site in Spain.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Cabrera Martos (958248763, irenecm@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gugging Swallowing screen (time frame: Baseline, 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2024.