The Manifestation of Surface EMG of Swallowing Muscles in Stroke Patients With Respiratory Muscle Training. A Prospective Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Surface EMG data
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
IMST group
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: Respiratory muscle training for IMST (Other)
IMST group
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: Regular Rehabilitation (Other)
Control group
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: Regular Rehabilitation (Other)
EMST group
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: Regular Rehabilitation (Other)
EMST group
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: Respiratory muscle training for EMST (Other)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Peak cough flow(liter/min)(At the beginning and the end of program respectively, up to 6 weeks.)
- Resting respiratory rate(At the beginning and the end of program respectively, up to 6 weeks.)
- Resting heart rate(At the beginning and the end of program respectively, up to 6 weeks.)
- Functional Oral Intake Scale(At the beginning and the end of program respectively, up to 6 weeks.)
- Forced vital capacity, FVC(liter)(At the beginning and the end of program respectively, up to 6 weeks.)
- Fatigue Assessment Scale(At the beginning and the end of program respectively, up to 6 weeks.)
- Forced vital capacity, FVC(%pred)(liter)(At the beginning and the end of program respectively, up to 6 weeks.)
- Forced expiratory volume 1/Forced vital capacity, FEV1/FVC(%)(At the beginning and the end of program respectively, up to 6 weeks.)
- Maximal mid-expiratory flow, MMEF(%)(At the beginning and the end of program respectively, up to 6 weeks.)
- Borg's Scale(At the beginning and the end of program respectively, up to 6 weeks.)