StrokeNCT06322368
Myofunctional and Respiratory Intervention on Phonation in Stroke
A study testing Myofunctional and respiratory training program and Range of motion and thermal and mechanical stimulation exercising in people with Stroke, run by Universidad de Granada at 1 site in Spain.
Trial summary
Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Myofunctional and respiratory training program and Range of motion and thermal and mechanical stimulation exercising
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 1 Jul 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
- Patients with a clinical diagnosis of chronic stroke (duration above 6 months).
- Age over 18 years
Who cannot join
- Communication or cognitive deficits that prevented them from following verbal commands.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences
Granada, 18016
Irene Cabrera Martos, irenecm@ugr.es
irenecm@ugr.es
About this study
Official title: Effects of a Combined Myofunctional and Respiratory Intervention on Phonation in Patients With Chronic Stroke
Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes.
Read the detailed description
Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented to improve phonation outcomes. Myofunctional therapy is based on exercise training program for the muscles around your face, mouth, and tongue. Respiratory muscle strength training focuses on increasing the force-generating capacity of the inspiratory and expiratory muscles. A combination of both may be of interest to improve phonation parameters.
- Conditions
- Stroke
- Being tested
- Myofunctional and respiratory training program, Range of motion and thermal and mechanical stimulation exercising
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofunctional and respiratory training programOther
The patients will receive exercises included in a myofunctional approach and a respiratory training focused on inspiratory and expiratory muscles using a device.
Range of motion and thermal and mechanical stimulation exercisingOther
The patients will receive the standard treatment of speech and language therapy including range of motion exercises (open and close the mouth) and thermal and mechanical stimulation in the orofacial region.
| Study group | Role | What they receive |
|---|---|---|
| Myofunctional and respiratory training | Experimental | Patients with chronic stroke receiving an exercise training program for the muscles around the face, mouth, and tongue and a respiratory training focused on inspiratory and expiratory muscle strengthening. Receives: Other: Myofunctional and respiratory training program |
| Range of motion and stimulation exercises | Active comparator | Standard treatment focused mainly on range of motion, such as opening and closing the mouth and stimulation exercises Receives: Other: Range of motion and thermal and mechanical stimulation exercising |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume during monologue
The volumen during a monologue of basic activities of daily living assessed in decibels.
Measured: Baseline, 6 weeks
Frequency during monologue
The frequency during a monologue of basic activities of daily living expressed in hertz.
Measured: Baseline, 6 weeks
Secondary outcomes (5)
Volumen during sustained phonation of /s/ sound
The decibels during the maximum sustained phonation of s.
Measured: Baseline, 6 weeks
Communication effectiveness Index
This is a questionnaire with the scores ranging from 0 to 100, with lower scores meaning more difficulties associated to effectiveness in communication.
Measured: Baseline, 6 weeks
Frequency during sustained phonation of /s/ sound
The Hertzs during the maximum sustained phonation of s.
Measured: Baseline, 6 weeks
Volumen during sustained phonation of /a/ sound
The decibels during the maximum sustained phonation of a.
Measured: Baseline, 6 weeks
Frequency during sustained phonation of /a/ sound
The Hertzs during the maximum sustained phonation of a
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 posted21 Mar 2024
- Study start1 Dec 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Jul 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
- 30 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
- NCT06322368
- Sponsor's protocol ID
- DF002
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Combined Myofunctional and Respiratory Intervention on Phonation in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06322368
- Acronym / sponsor ID
- DF002
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 21 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.
Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes.
Detailed description
Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented to improve phonation outcomes. Myofunctional therapy is based on exercise training program for the muscles around your face, mouth, and tongue. Respiratory muscle strength training focuses on increasing the force-generating capacity of the inspiratory and expiratory muscles. A combination of both may be of interest to improve phonation parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofunctional and respiratory training | Experimental | Other: Myofunctional and respiratory training programPatients with chronic stroke receiving an exercise training program for the muscles around the face, mouth, and tongue and a respiratory training focused on inspiratory and expiratory muscle strengthening. |
| Range of motion and stimulation exercises | Active comparator | Other: Range of motion and thermal and mechanical stimulation exercisingStandard treatment focused mainly on range of motion, such as opening and closing the mouth and stimulation 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)
- Patients with a clinical diagnosis of chronic stroke (duration above 6 months).
- Age over 18 years
Key exclusion criteria (1 listed)
- Communication or cognitive deficits that prevented them from following verbal commands.
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 |
|---|---|---|
| Myofunctional and respiratory training programThe patients will receive exercises included in a myofunctional approach and a respiratory training focused on inspiratory and expiratory muscles using a device. | Other | Myofunctional and respiratory training |
| Range of motion and thermal and mechanical stimulation exercisingThe patients will receive the standard treatment of speech and language therapy including range of motion exercises (open and close the mouth) and thermal and mechanical stimulation in the orofacial region. | Other | Range of motion and stimulation exercises |
Primary outcome
Volume during monologue
Time frame: Baseline, 6 weeks
The volumen during a monologue of basic activities of daily living assessed in decibels.
Frequency during monologue
Time frame: Baseline, 6 weeks
The frequency during a monologue of basic activities of daily living expressed in hertz.
5 secondary outcomes
Volumen during sustained phonation of /s/ sound
Time frame: Baseline, 6 weeks
Communication effectiveness Index
Time frame: Baseline, 6 weeks
Frequency during sustained phonation of /s/ sound
Time frame: Baseline, 6 weeks
Volumen during sustained phonation of /a/ sound
Time frame: Baseline, 6 weeks
Frequency during sustained phonation of /a/ sound
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 21 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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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 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 Myofunctional and respiratory training program and Range of motion and thermal and mechanical stimulation exercising 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 1 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 21 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?
Volume during monologue (time frame: Baseline, 6 weeks). The study lists 2 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 21 Mar 2024.