search
Back to results

The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training

Primary Purpose

Cerebrovascular Disorders

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Respiratory muscle training for IMST
Regular Rehabilitation
Respiratory muscle training for EMST
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Disorders focused on measuring Respiratory muscle training, Spirometry, Maximal Inspiratory Pressure, Maximal Expiratory pressure, Surface electromyography

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients identified as stroke,
  • Diagnosed by magnetic resonance image or computerized tomography
  • Capable of performing voluntary respiratory maneuvers

Exclusion Criteria:

  • Increased intracranial pressure
  • Uncontrolled hypertension
  • Complicated arrhythmia
  • Decompensated heart failure
  • Unstable angina
  • Myocardial infarction in the preceding 3 months
  • Pneumothorax
  • Bullae/blebs
  • Severe cognitive function
  • Emotional disturbance
  • Infection

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

IMST group

Control group

EMST group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Forced vital capacity, FVC(liter)
Pulmonary functional test, the determination of the vital capacity from a maximally forced expiratory effort.
Forced vital capacity, FVC(%pred)(liter)
Pulmonary functional test, the determination of the vital capacity from a maximally forced expiratory effort.
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.
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.
Peak cough flow(liter/min)
Maximum speed of expiration.
Resting heart rate
Heart rate of patient during resting.
Resting respiratory rate
Respiratory rate of patient during resting.
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.
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
Fatigue Assessment Scale
Score: 5-50. 1 = Never, 2 = Sometimes; 3 = Regularly; 4 = Often and 5 = Always. 10 items.

Full Information

First Posted
December 5, 2018
Last Updated
November 15, 2020
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03767998
Brief Title
The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training
Official Title
The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training. A Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders
Keywords
Respiratory muscle training, Spirometry, Maximal Inspiratory Pressure, Maximal Expiratory pressure, Surface electromyography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMST group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EMST group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Respiratory muscle training for IMST
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Regular Rehabilitation
Intervention Description
Regular Rehabilitation: 2-3 times a week, 6 weeks.
Intervention Type
Other
Intervention Name(s)
Respiratory muscle training for EMST
Intervention Description
5 sets, 5 repetition with one or two minute of rest between sets, twice per day, 5 days per week, training with breathing trainer.
Primary Outcome Measure Information:
Title
MIP (maximal inspiratory pressure)
Description
MIP(cm H20) is measured after maximal expiration while patients sitting and wearing a nose-clip. For MIP, more negative pressure is better.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
MEP (maximal expiratory pressure)
Description
MEP(cm H20) is measured after maximal inspiration while patients sitting and wearing a nose-clip. For MEP, more positive is better.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
Surface EMG data
Description
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
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Secondary Outcome Measure Information:
Title
Forced vital capacity, FVC(liter)
Description
Pulmonary functional test, the determination of the vital capacity from a maximally forced expiratory effort.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
Forced vital capacity, FVC(%pred)(liter)
Description
Pulmonary functional test, the determination of the vital capacity from a maximally forced expiratory effort.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
Forced expiratory volume 1/Forced vital capacity, FEV1/FVC(%)
Description
Pulmonary functional test, a calculated ratio used in the diagnosis of obstructive and restrictive lung disease.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
Maximal mid-expiratory flow, MMEF(%)
Description
Pulmonary functional test, the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
Peak cough flow(liter/min)
Description
Maximum speed of expiration.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
Resting heart rate
Description
Heart rate of patient during resting.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
Resting respiratory rate
Description
Respiratory rate of patient during resting.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
Functional Oral Intake Scale
Description
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.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
Borg's Scale
Description
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
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.
Title
Fatigue Assessment Scale
Description
Score: 5-50. 1 = Never, 2 = Sometimes; 3 = Regularly; 4 = Often and 5 = Always. 10 items.
Time Frame
At the beginning and the end of program respectively, up to 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients identified as stroke, Diagnosed by magnetic resonance image or computerized tomography Capable of performing voluntary respiratory maneuvers Exclusion Criteria: Increased intracranial pressure Uncontrolled hypertension Complicated arrhythmia Decompensated heart failure Unstable angina Myocardial infarction in the preceding 3 months Pneumothorax Bullae/blebs Severe cognitive function Emotional disturbance Infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liaw Mei-Yun, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.
City
Kaohsiung
ZIP/Postal Code
83305
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training

We'll reach out to this number within 24 hrs