Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03767998
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2018-12-05
Brief Title:
The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training A Prospective Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Brunnstroms stage muscle power spirometry peak cough flow maximal inspiratory pressure MIPmaximal 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 individuals 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
Each patient will receive baseline characteristics duration of stroke Brunnstroms stage muscle power spirometry peak cough flow maximal inspiratory pressure MIPmaximal 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 individuals 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 patientsWheeler 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 deviceThreshold type to train respiratory muscles and follow up its effect on swallowing cough voice quality in stroke patients with respiratory muscle weakness andor 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 Brunnstroms stage spirometry peak cough flow resting heart rate systolic and diastolic blood pressure resting oxyhemoglobin saturation SpO2 MIP MEP Borgs scale 05 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 program6 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 individuals 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
GroupIIIControl group will receive regular rehabilitation
Outcome measurements
Each subjects baseline characteristics including height weight body mass index and duration of the disease neurological level Brunnstroms stage spirometry resting heart rate rest respiratory rate blood pressure resting oxyhemoglobin saturation SpO2 MIP MEP or the lowest resting SpO2 Borgs 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 inĪ¼sec 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
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 patientsWheeler 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 deviceThreshold type to train respiratory muscles and follow up its effect on swallowing cough voice quality in stroke patients with respiratory muscle weakness andor 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 Brunnstroms stage spirometry peak cough flow resting heart rate systolic and diastolic blood pressure resting oxyhemoglobin saturation SpO2 MIP MEP Borgs scale 05 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 program6 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 individuals 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
GroupIIIControl group will receive regular rehabilitation
Outcome measurements
Each subjects baseline characteristics including height weight body mass index and duration of the disease neurological level Brunnstroms stage spirometry resting heart rate rest respiratory rate blood pressure resting oxyhemoglobin saturation SpO2 MIP MEP or the lowest resting SpO2 Borgs 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 inĪ¼sec 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None