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

NCT03767998 | Completed DMC

• 1 other identifier: CMRPG8F0961
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Disorders

Keywords

Respiratory muscle training; Spirometry; Maximal Inspiratory Pressure; Maximal Expiratory pressure; Surface electromyography

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  At the beginning and the end of program respectively, up to 6 weeks.

Secondary Outcomes (10)

• Forced vital capacity, FVC(liter)

  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.

• Peak cough flow(liter/min)

  At the beginning and the end of program respectively, up to 6 weeks.

Study Arms (3)

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.

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.

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.

Other: Regular Rehabilitation; Other: Respiratory muscle training for EMST

Interventions

Respiratory muscle training for IMST OTHER

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.

IMST group

Regular Rehabilitation OTHER

Regular Rehabilitation: 2-3 times a week, 6 weeks.

Control group; EMST group; IMST group

Respiratory muscle training for EMST OTHER

5 sets, 5 repetition with one or two minute of rest between sets, twice per day, 5 days per week, training with breathing trainer.

EMST group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

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

Kaohsiung City, 83305, Taiwan

Location

MeSH Terms

Conditions

Cerebrovascular Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Liaw Mei-Yun, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: May 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: June 30, 2019
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)