Cerebrovascular DisordersNCT03767998
The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training
A study testing Respiratory muscle training for IMST, Regular Rehabilitation and Respiratory muscle training for EMST in people with Cerebrovascular Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Purpose: To investigate of the respiratory function and swallowing function after respiratory muscle training, and the manifestation of surface EMG of swallowing muscles, and the lateralization of placement of electrodes in stroke patients. Methods: A prospective study. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cerebrovascular Disorders
- What is being tested?
- Respiratory muscle training for IMST, Regular Rehabilitation and Respiratory muscle training for EMST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2017to 30 Jun 2019
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients identified as stroke,
- Diagnosed by magnetic resonance image or computerized tomography
- Capable of performing voluntary respiratory maneuvers
Who cannot join
- Increased intracranial pressure
- Uncontrolled hypertension
- Complicated arrhythmia
- Decompensated heart failure
- Unstable angina
- Myocardial infarction in the preceding 3 months
Show all 11Show fewer
- Pneumothorax
- Bullae/blebs
- Severe cognitive function
- Emotional disturbance
- Infection
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.
Kaohsiung City, 83305
About this study
Official title: The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training. A Prospective Study.
Purpose: To investigate of the respiratory function and swallowing function after respiratory muscle training, and the manifestation of surface EMG of swallowing muscles, and the lateralization of placement of electrodes in stroke patients. Methods: A prospective study. Consecutive patients with diagnosis of stroke will be proved by magnetic resonance image or computerized tomography. Stroke patients, aged 35-80 years old, with inspiratory muscle weakness or swallowing disturbance will be enrolled and randomly divided into control group (usual rehabilitation alone) and experimental group (inspiratory muscle strengthening training (IMST) group for patients with inspiratory muscle weakness and expiratory muscle strengthening training (EMST) for patients with swallowing disturbance, respectively. Each patients will receive usual rehabilitation. In the meanwhile we will recruit 23 healthy subjects for the control group.
Each patient will receive baseline characteristics, duration of stroke, Brunnstrom's stage, muscle power, spirometry, peak cough flow, maximal inspiratory pressure (MIP),maximal expiratory pressure (MEP), resting heart rate, perception of dyspnea, resting oxyhemoglobin saturation (SpO2), hand grip strength of unaffected upper limb. And patients with swallowing disturbance will receive swallowing screen test, Functional Oral Intake Scale to evaluate the functional level of oral intake of food and liquid, and voice quality analysis for voice quality and bilateral surface electromyography for measurement of masseter, oris orbicularis, submental muscle and infraspinatus muscles. All of patients will be assessed again at 6 weeks and 12 weeks later.
Patient with respiratory muscle weakness will receive IMT from 30% to 60 % of MIP through a respiratory trainer for two sets of 30 breaths or 6 sets of 10 repetitions. For patients with swallowing disturbance, EMST will commence from 15% to 75% of threshold load of an individual's MEP, 5 sets, 5 repetition with one minute of rest between sets.. The training resistance will be adjusted accordingly, with one or two minute of rest between sets. Both group will receive respiratory training, twice per day, 5 days per week. For checking the compliance of RMT at home, patients will be monitored by making a phone call to them once a week.
Read the detailed description
Stroke patients commonly to have respiratory muscle weakness and swallowing disturbance. Their cardiorespiratory function could be markedly impaired within 7 weeks after a stroke, and maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) reduced. Dysphagic patients usually had reduced hyolaryngeal excursion. The contraction of submandibular hyolaryngeal muscles (geniohyoid, mylohyoid, anterior digastric) and thyohyoid muscles can influence on the hyoid bone and largynx . The decreased excursion and elevation of hyolaryngeal complex has been considered as one of cause of penetration and aspiration in patients with dysphagia.
Respiratory muscle training (RMT) could improve cough effectiveness and reduce the incidence of pneumonia in acute stroke. RMT could significantly increase in MIP and MEP with training intensity of inspiratory muscle training (IMT) varied from 30% to 60% of MIP, duration of 3 to 7 times per week and duration of each session from 10-30 minutes for a period of training from 6 to12 weeks in subacute stroke patients.
Expiratory muscle strength training (EMST) had potential benefit for respiratory muscle strength, swallowing and cough function. EMST could significantly increase duration of activation with higher peak amplitudes of EMG signal of the submental muscles as compared to dry and wet swallowing in stroke patients(Wheeler, et al. 2007) and it also had promising outcomes for airway protection in persons with dysphagia second to neuromuscular impairment.
Swallowing phase including oral phase, pharyngeal phase, pharyngeal and initial esophageal pahased. Surface EMG (sEMG), a simple, noninvasive, radiation-free and reliable method, can be used to screen and differentiate the swallowing disturbance by recording activity of surface EMG over the swallowing muscles, including orbicularis oris, masseters, submental muscles and infrahyoid muscles. The electric activity of sEMG can be filtered and rectified as EkG-looking line. It can provide complementary information to assess the dysphagia.
Correlation of sEMG signals during swallowing in healthy adults has been reported And stroke patients with middle cerebral artery infarction had delayed swallowing onset, pretrigger duration of hyoid bone. The sEMG showed shorter duration of sEMG activity, latency between the start of EMG activity and actual movement, shortened submental muscle activity, and prolonged pretrigger duration during swallowing.
Hypothesis Respiratory muscle training can activate the respiratory muscles, stimulate motor cortex of central nervous system of speech, swallowing and respiratory function through the certain process of neuroplasticity in brain and spinal cord. EMST could facilitate submental muscle contraction, increase submental muscle force and elevate the hyolaryngeal complex during swallowing.
However, rare reports regarding the relationship between the respiratory muscle training and swallowing dysfunction in stroke patients. And stroke patients with different lesions may have specific sEMG patterns; the differentiation of sEMG pattern of swallowing muscles in different stroke disease with dysphagia is not explored yet, and also short of standards to study the sEMG of swallowing muscles.
In this study, we will use a simple respiratory muscle training device(Threshold type) to train respiratory muscles and follow up its effect on swallowing, cough, voice quality in stroke patients with respiratory muscle weakness and/or swallowing disturbance.
Forty-six stroke patients with respiratory muscle weakness, age between 35 to 80 years, will be enrolled. The participants will be randomly assigned by a computer random number generator into two groups, including the experimental group (RMT group plus usual rehabilitation) and the control group (usual rehabilitation alone). All allocations will be concealed in the opaque envelopes. The research assistant will enroll the participants, generate the allocation sequence, and assign participants to their groups after obtaining the informed consent.
The patient will be randomized into 3 groups:
Group I: IMST only: inspiratory muscle training for patients with inspiratory muscle weakness (MIP less than 70% of normal range).
Group II: EMST: for patients with swallowing disturbance.
Group III: Control group will receive regular rehabilitation.
Each subject with respiratory muscle weakness or swallowing disturbance, baseline characteristics, including height, weight, body mass index, duration of the disease, neurological level (Brunnstrom's stage), spirometry, peak cough flow, resting heart rate, systolic and diastolic blood pressure, resting oxyhemoglobin saturation (SpO2), MIP, MEP, Borg's scale (0.5 to 10), 6-minute walking test, cough function, fatigue assessment scale and caregiver stress scale. Pulmonary function and respiratory muscle strength will be assessed by an experienced technician in our pulmonary functional room as a baseline at the begin of training program, and at end of program(6 weeks).
Training protocol:
Group I: IMST only:
IMT will commence from 30% to 60 % of MIP and then adjust one level of training loading according to the tolerance of continuously breathing through a respiratory trainer for two sets of 30 breaths or 6 sets of 10 repetitions with one or two minute of rest between sets, once per day, 5 days per week. Training resistance will be adjusted as tolerated. The loading will be performed with the previous resistance setting or even lower if training load is not tolerated or not completed.
During IMT, patients will be instructed to place their lips around breathing trainer in a sitting position with a nose-clip, inhale with enough force to open the valve (inhale deeply and forcefully), exhale through the mouthpiece (exhale slowly and gently), and then continue inhaling and exhaling without removing the device from their mouths. The training load and training program will be instructed by an experienced respiratory technician.
Group II: EMST: for patients with only swallowing disturbance EMST will commence from 15% to 75% of threshold load of an individual's MEP, 5 sets, 5 repetition with one or two minute of rest between sets, twice per day, 5 days per week. And training resistance will be adjusted accordingly. The loading will be performed with the previous resistance setting or even lower if training load is not tolerated or not completed. Each patients with swallowing disturbance will receive swallowing screen test, Functional Oral Intake Scale, voice quality analysis and surface electromyography by an experience physician and experienced speech therapist to evaluate the functional level of oral intake of food and liquid, voice quality and measurement of submental muscle strength respectively. And swallowing training program will be conducted by an experienced speech therapist.
GroupIII:Control group will receive regular rehabilitation.
Outcome measurements:
Each subject's baseline characteristics, including height, weight, body mass index, and duration of the disease, neurological level (Brunnstrom's stage), spirometry, resting heart rate, rest respiratory rate, blood pressure, resting oxyhemoglobin saturation (SpO2), MIP, MEP, or the lowest resting SpO2, Borg's scale, six-minute walk work value and distance, six-minute upper extremity ergometry, peak cough flow, non-affected upper limb strength, fatigue assessment scale etc.
For rectified and filtered sEMG, swallowing duration (the time lapse between the start and the end of swallowing. In second), mean peak amplitude (inμsec), and shape of contraction patterns of different stage of swallowing will be analyzed.
The timing of serial evaluation including the assessment at baseline, 6 weeks and 3 month later.
- Conditions
- Cerebrovascular Disorders
- Being tested
- Respiratory muscle training for IMST, Regular Rehabilitation, Respiratory muscle training for EMST
- Keywords
- Respiratory muscle training, Spirometry, Maximal Inspiratory Pressure, Maximal Expiratory pressure, Surface electromyography
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle training for IMSTOther
2 sets of 30 breaths or 6 sets of 10 repetitions with one or two minute of rest between sets, once per day, 5 days per week, training with breathing trainer.
Regular RehabilitationOther
Regular Rehabilitation: 2-3 times a week, 6 weeks.
Respiratory muscle training for EMSTOther
5 sets, 5 repetition with one or two minute of rest between sets, twice per day, 5 days per week, training with breathing trainer.
| Study group | Role | What they receive |
|---|---|---|
| IMST group | Experimental | Interventions: Respiratory muscle training for IMST. Inspiratory muscle training for patients with inspiratory muscle weakness (MIP less than 70% of normal range). IMT will commence from 30% to 60 % of MIP and then adjust one level of training loading according to the tolerance of continuously breathing through a respiratory trainer for two sets of 30 breaths or 6 sets of 10 repetitions with one or two minute of rest between sets, once per day, 5 days per week. Receives: Other: Respiratory muscle training for IMST; Other: Regular Rehabilitation |
| Control group | Active comparator | Intervention: Non-training group, receive regular rehabilitation. All participants will receive usual rehabilitation care including body positioning instruction, postural correction, breathing control, cough maneuver, respiratory muscle stretch, chest wall mobility exercise and ventilation, fatigue management. Receives: Other: Regular Rehabilitation |
| EMST group | Experimental | Intervention: Respiratory muscle training for EMST. For patients with only swallowing disturbance. Training resistance will be adjusted accordingly. The loading will be performed with the previous resistance setting or even lower if training load is not tolerated or not completed. Receives: Other: Regular Rehabilitation; Other: Respiratory muscle training for EMST |
What is being measured
The primary outcome is the main question the study is designed to answer.
MIP (maximal inspiratory pressure)
MIP(cm H20) is measured after maximal expiration while patients sitting and wearing a nose-clip. For MIP, more negative pressure is better.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
MEP (maximal expiratory pressure)
MEP(cm H20) is measured after maximal inspiration while patients sitting and wearing a nose-clip. For MEP, more positive is better.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Surface EMG data
The EMG of masseter, orbicularis oris, submental (anterior belly of digastrics, mylohyoid, geniohyoid) and infrahyoid muscles will be recorded. Three trials of dry swallowing, voluntary water swallowing, and breathing through a breathing trainer in low intensity and about 50% of the measured intensity of maximal expiratory pressure at beginning of program will be recorded
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Secondary outcomes (10)
Forced vital capacity, FVC(liter)
Pulmonary functional test, the determination of the vital capacity from a maximally forced expiratory effort.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Forced vital capacity, FVC(%pred)(liter)
Pulmonary functional test, the determination of the vital capacity from a maximally forced expiratory effort.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Forced expiratory volume 1/Forced vital capacity, FEV1/FVC(%)
Pulmonary functional test, a calculated ratio used in the diagnosis of obstructive and restrictive lung disease.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Maximal mid-expiratory flow, MMEF(%)
Pulmonary functional test, the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Peak cough flow(liter/min)
Maximum speed of expiration.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Resting heart rate
Heart rate of patient during resting.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Resting respiratory rate
Respiratory rate of patient during resting.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Functional Oral Intake Scale
Level 1: Nothing by mouth. Level 2: Tube dependent with minimal attempts of food or liquid. Level 3: Tube dependent with consistent oral intake of food or liquid. Level 4: Total oral diet of a single consistency. Level 5: Total oral diet with multiple consistencies, but requiring special preparation or compensations.Level 6: Total oral diet with multiple consistencies without special preparation, but with specific food limitations. Level 7: Total oral diet with no restrictions. Level 1 to level 7.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Borg's Scale
Modified Borg scale (0.5 to 10) 0 Nothing at all 0.5 Very, very slight (just noticeable)
- Very slight
- Slight
- Moderate
- Somewhat severe
- Severe
7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Fatigue Assessment Scale
Score: 5-50. 1 = Never, 2 = Sometimes; 3 = Regularly; 4 = Often and 5 = Always. 10 items.
Measured: At the beginning and the end of program respectively, up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 May 2017
- Primary completion31 Oct 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liaw Mei-Yun, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767998
- Sponsor's protocol ID
- CMRPG8F0961
- Status last verified
- Nov 2020
- First submitted
- 5 Dec 2018
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training. A Prospective Study.
- ClinicalTrials.gov ID
- NCT03767998
- Acronym / sponsor ID
- CMRPG8F0961
- Conditions
- Cerebrovascular Disorders
- Keywords
- Respiratory muscle training, Spirometry, Maximal Inspiratory Pressure, Maximal Expiratory pressure, Surface electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 7 Dec 2018 (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.
Purpose: To investigate of the respiratory function and swallowing function after respiratory muscle training, and the manifestation of surface EMG of swallowing muscles, and the lateralization of placement of electrodes in stroke patients. Methods: A prospective study. Consecutive patients with diagnosis of stroke will be proved by magnetic resonance image or computerized tomography. Stroke patients, aged 35-80 years old, with inspiratory muscle weakness or swallowing disturbance will be enrolled and randomly divided into control group (usual rehabilitation alone) and experimental group (inspiratory muscle strengthening training (IMST) group for patients with inspiratory muscle weakness and expiratory muscle strengthening training (EMST) for patients with swallowing disturbance, respectively. Each patients will receive usual rehabilitation. In the meanwhile we will recruit 23 healthy subjects for the control group.
Each patient will receive baseline characteristics, duration of stroke, Brunnstrom's stage, muscle power, spirometry, peak cough flow, maximal inspiratory pressure (MIP),maximal expiratory pressure (MEP), resting heart rate, perception of dyspnea, resting oxyhemoglobin saturation (SpO2), hand grip strength of unaffected upper limb. And patients with swallowing disturbance will receive swallowing screen test, Functional Oral Intake Scale to evaluate the functional level of oral intake of food and liquid, and voice quality analysis for voice quality and bilateral surface electromyography for measurement of masseter, oris orbicularis, submental muscle and infraspinatus muscles. All of patients will be assessed again at 6 weeks and 12 weeks later.
Patient with respiratory muscle weakness will receive IMT from 30% to 60 % of MIP through a respiratory trainer for two sets of 30 breaths or 6 sets of 10 repetitions. For patients with swallowing disturbance, EMST will commence from 15% to 75% of threshold load of an individual's MEP, 5 sets, 5 repetition with one minute of rest between sets.. The training resistance will be adjusted accordingly, with one or two minute of rest between sets. Both group will receive respiratory training, twice per day, 5 days per week. For checking the compliance of RMT at home, patients will be monitored by making a phone call to them once a week.
Detailed description
Stroke patients commonly to have respiratory muscle weakness and swallowing disturbance. Their cardiorespiratory function could be markedly impaired within 7 weeks after a stroke, and maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) reduced. Dysphagic patients usually had reduced hyolaryngeal excursion. The contraction of submandibular hyolaryngeal muscles (geniohyoid, mylohyoid, anterior digastric) and thyohyoid muscles can influence on the hyoid bone and largynx . The decreased excursion and elevation of hyolaryngeal complex has been considered as one of cause of penetration and aspiration in patients with dysphagia.
Respiratory muscle training (RMT) could improve cough effectiveness and reduce the incidence of pneumonia in acute stroke. RMT could significantly increase in MIP and MEP with training intensity of inspiratory muscle training (IMT) varied from 30% to 60% of MIP, duration of 3 to 7 times per week and duration of each session from 10-30 minutes for a period of training from 6 to12 weeks in subacute stroke patients.
Expiratory muscle strength training (EMST) had potential benefit for respiratory muscle strength, swallowing and cough function. EMST could significantly increase duration of activation with higher peak amplitudes of EMG signal of the submental muscles as compared to dry and wet swallowing in stroke patients(Wheeler, et al. 2007) and it also had promising outcomes for airway protection in persons with dysphagia second to neuromuscular impairment.
Swallowing phase including oral phase, pharyngeal phase, pharyngeal and initial esophageal pahased. Surface EMG (sEMG), a simple, noninvasive, radiation-free and reliable method, can be used to screen and differentiate the swallowing disturbance by recording activity of surface EMG over the swallowing muscles, including orbicularis oris, masseters, submental muscles and infrahyoid muscles. The electric activity of sEMG can be filtered and rectified as EkG-looking line. It can provide complementary information to assess the dysphagia.
Correlation of sEMG signals during swallowing in healthy adults has been reported And stroke patients with middle cerebral artery infarction had delayed swallowing onset, pretrigger duration of hyoid bone. The sEMG showed shorter duration of sEMG activity, latency between the start of EMG activity and actual movement, shortened submental muscle activity, and prolonged pretrigger duration during swallowing.
Hypothesis Respiratory muscle training can activate the respiratory muscles, stimulate motor cortex of central nervous system of speech, swallowing and respiratory function through the certain process of neuroplasticity in brain and spinal cord. EMST could facilitate submental muscle contraction, increase submental muscle force and elevate the hyolaryngeal complex during swallowing.
However, rare reports regarding the relationship between the respiratory muscle training and swallowing dysfunction in stroke patients. And stroke patients with different lesions may have specific sEMG patterns; the differentiation of sEMG pattern of swallowing muscles in different stroke disease with dysphagia is not explored yet, and also short of standards to study the sEMG of swallowing muscles.
In this study, we will use a simple respiratory muscle training device(Threshold type) to train respiratory muscles and follow up its effect on swallowing, cough, voice quality in stroke patients with respiratory muscle weakness and/or swallowing disturbance.
Forty-six stroke patients with respiratory muscle weakness, age between 35 to 80 years, will be enrolled. The participants will be randomly assigned by a computer random number generator into two groups, including the experimental group (RMT group plus usual rehabilitation) and the control group (usual rehabilitation alone). All allocations will be concealed in the opaque envelopes. The research assistant will enroll the participants, generate the allocation sequence, and assign participants to their groups after obtaining the informed consent.
The patient will be randomized into 3 groups:
Group I: IMST only: inspiratory muscle training for patients with inspiratory muscle weakness (MIP less than 70% of normal range).
Group II: EMST: for patients with swallowing disturbance.
Group III: Control group will receive regular rehabilitation.
Each subject with respiratory muscle weakness or swallowing disturbance, baseline characteristics, including height, weight, body mass index, duration of the disease, neurological level (Brunnstrom's stage), spirometry, peak cough flow, resting heart rate, systolic and diastolic blood pressure, resting oxyhemoglobin saturation (SpO2), MIP, MEP, Borg's scale (0.5 to 10), 6-minute walking test, cough function, fatigue assessment scale and caregiver stress scale. Pulmonary function and respiratory muscle strength will be assessed by an experienced technician in our pulmonary functional room as a baseline at the begin of training program, and at end of program(6 weeks).
Training protocol:
Group I: IMST only:
IMT will commence from 30% to 60 % of MIP and then adjust one level of training loading according to the tolerance of continuously breathing through a respiratory trainer for two sets of 30 breaths or 6 sets of 10 repetitions with one or two minute of rest between sets, once per day, 5 days per week. Training resistance will be adjusted as tolerated. The loading will be performed with the previous resistance setting or even lower if training load is not tolerated or not completed.
During IMT, patients will be instructed to place their lips around breathing trainer in a sitting position with a nose-clip, inhale with enough force to open the valve (inhale deeply and forcefully), exhale through the mouthpiece (exhale slowly and gently), and then continue inhaling and exhaling without removing the device from their mouths. The training load and training program will be instructed by an experienced respiratory technician.
Group II: EMST: for patients with only swallowing disturbance EMST will commence from 15% to 75% of threshold load of an individual's MEP, 5 sets, 5 repetition with one or two minute of rest between sets, twice per day, 5 days per week. And training resistance will be adjusted accordingly. The loading will be performed with the previous resistance setting or even lower if training load is not tolerated or not completed. Each patients with swallowing disturbance will receive swallowing screen test, Functional Oral Intake Scale, voice quality analysis and surface electromyography by an experience physician and experienced speech therapist to evaluate the functional level of oral intake of food and liquid, voice quality and measurement of submental muscle strength respectively. And swallowing training program will be conducted by an experienced speech therapist.
GroupIII:Control group will receive regular rehabilitation.
Outcome measurements:
Each subject's baseline characteristics, including height, weight, body mass index, and duration of the disease, neurological level (Brunnstrom's stage), spirometry, resting heart rate, rest respiratory rate, blood pressure, resting oxyhemoglobin saturation (SpO2), MIP, MEP, or the lowest resting SpO2, Borg's scale, six-minute walk work value and distance, six-minute upper extremity ergometry, peak cough flow, non-affected upper limb strength, fatigue assessment scale etc.
For rectified and filtered sEMG, swallowing duration (the time lapse between the start and the end of swallowing. In second), mean peak amplitude (inμsec), and shape of contraction patterns of different stage of swallowing will be analyzed.
The timing of serial evaluation including the assessment at baseline, 6 weeks and 3 month later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMST group | Experimental | Other: Respiratory muscle training for IMST, Other: Regular RehabilitationInterventions: Respiratory muscle training for IMST. Inspiratory muscle training for patients with inspiratory muscle weakness (MIP less than 70% of normal range). IMT will commence from 30% to 60 % of MIP and then adjust one level of training loading according to the tolerance of continuously breathing through a respiratory trainer for two sets of 30 breaths or 6 sets of 10 repetitions with one or two minute of rest between sets, once per day, 5 days per week. |
| Control group | Active comparator | Other: Regular RehabilitationIntervention: Non-training group, receive regular rehabilitation. All participants will receive usual rehabilitation care including body positioning instruction, postural correction, breathing control, cough maneuver, respiratory muscle stretch, chest wall mobility exercise and ventilation, fatigue management. |
| EMST group | Experimental | Other: Regular Rehabilitation, Other: Respiratory muscle training for EMSTIntervention: Respiratory muscle training for EMST. For patients with only swallowing disturbance. Training resistance will be adjusted accordingly. The loading will be performed with the previous resistance setting or even lower if training load is not tolerated or not completed. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients identified as stroke,
- Diagnosed by magnetic resonance image or computerized tomography
- Capable of performing voluntary respiratory maneuvers
Key exclusion criteria (11 listed)
- Increased intracranial pressure
- Uncontrolled hypertension
- Complicated arrhythmia
- Decompensated heart failure
- Unstable angina
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 muscle training for IMST2 sets of 30 breaths or 6 sets of 10 repetitions with one or two minute of rest between sets, once per day, 5 days per week, training with breathing trainer. | Other | IMST group |
| Regular RehabilitationRegular Rehabilitation: 2-3 times a week, 6 weeks. | Other | Control group, EMST group, IMST group |
| Respiratory muscle training for EMST5 sets, 5 repetition with one or two minute of rest between sets, twice per day, 5 days per week, training with breathing trainer. | Other | EMST group |
Primary outcome
MIP (maximal inspiratory pressure)
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
MIP(cm H20) is measured after maximal expiration while patients sitting and wearing a nose-clip. For MIP, more negative pressure is better.
MEP (maximal expiratory pressure)
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
MEP(cm H20) is measured after maximal inspiration while patients sitting and wearing a nose-clip. For MEP, more positive is better.
Surface EMG data
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
The EMG of masseter, orbicularis oris, submental (anterior belly of digastrics, mylohyoid, geniohyoid) and infrahyoid muscles will be recorded. Three trials of dry swallowing, voluntary water swallowing, and breathing through a breathing trainer in low intensity and about 50% of the measured intensity of maximal expiratory pressure at beginning of program will be recorded
10 secondary outcomes
Forced vital capacity, FVC(liter)
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
Forced vital capacity, FVC(%pred)(liter)
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
Forced expiratory volume 1/Forced vital capacity, FEV1/FVC(%)
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
Maximal mid-expiratory flow, MMEF(%)
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
Peak cough flow(liter/min)
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
Resting heart rate
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
Resting respiratory rate
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
Functional Oral Intake Scale
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
Borg's Scale
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
Fatigue Assessment Scale
Time frame: At the beginning and the end of program respectively, up to 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
RecruitingObservational study
Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.
Reconstructive Surgical Procedures, Plastic Surgery
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
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.
Liaw Mei-Yun, MD principal investigator
Chang Gung Memorial Hospital
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 muscle training for IMST, Regular Rehabilitation and Respiratory muscle training for EMST in people with Cerebrovascular Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 17 Nov 2020. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIP (maximal inspiratory pressure) (time frame: At the beginning and the end of program respectively, up to 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 17 Nov 2020.