Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202205908494752 Date of Approval: 18/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EXPIRATORY MUSCLE TRAINING VERSUS FUNCTIONAL ELECTRICAL STIMULATION ON PULMONARY AND SWALLOWING FUNCTIONS IN PATIENTS WITH STROKE
Official scientific title EXPIRATORY MUSCLE TRAINING VERSUS FUNCTIONAL ELECTRICAL STIMULATION ON PULMONARY AND SWALLOWING FUNCTIONS IN PATIENTS WITH STROKE
Brief summary describing the background and objectives of the trial Stroke is recognized as a leading cause of death and disability worldwide and is associated with multiple medical complications leading to prolonged hospital admissions and significant health care costs. Occurrence of stroke dramatically reduces patients’ physical activity as a result of motor function impairment accompanied by muscle weakening. This increases the CO2 sensitivity of the paralyzed muscles and impairs voluntary breathing, inducing asymmetric respiration.Respiratory weakness is a major cause of morbidity and Mortality in stroke which causes weak respiratory muscles, decrease vital capacity, ineffective coughing, reduced in chest wall compliance, and excess oxygen in breathing due to respiratory distortion. Atelectasis, pneumonia, and ventilator failure are the most common complications during the first 5 days after stroke.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 11/05/2022
Actual trial start date
Anticipated date of last follow up 10/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Expiratory muscle strength training These patients will receive expiratory muscle strength training using (EMST 150) device (Aspire Products LLC., USA). The study will be one session per day, 30 minutes for each session, five times a week for 4 weeks Expiratory Muscle Strength Trainer device ( EMST150 ) (Aspire Products LLC., USA) is a calibrated expiratory muscle strength trainer designed specifically for individuals who want to enhance their breathing and swallow function 30 Active-Treatment of Control Group
Experimental Group Functional electrical stimulator for the anterior neck - Frequency (HZ): 30-50 HZ . - Amplitude (mA): The median maximum amplitude was 100 mA (range 100–450 mA) . - Pulse width (μs): the mean pulse width (pulse duration) was 259μs (range 25-400 μs ) - Duration: 30 minutes The patients will receive functional electrical stimulation for one session per day, 30 minutes for each session, five times a week for 4 weeks The patients will be trained using the functional electrical stimulation device (Ev-906, 4 CH Digital TENS/EMS, Taiwan). The functional electrical stimulation will be applied to the anterior neck and laryngeal elevator muscles of the larynx above and below the hyoid bone by using four surface electrodes for about 30 min using a four-channel electrical stimulator device 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The subject selection will be according to the following criteria: 1- All Patients of this study will be diagnosed as acute stroke with dysphagia and the diagnosis will be confirmed by computed tomography or MRI (El-Tamawy et al., 2021). 2- Age of patients will be ranged from 55 to 65years (males and females). 3- All patients will be hemodynamically stable. 4- All patients will be diagnosed as ischemic stroke 5- Patients with good cognition that enables them to understand the requirements of the study. 6- Patients with following features: (Abiodun A and Dolapo u , 2021)  FVC : 60-69% (moderate)  FEV1 : 60-69% (moderate)  FEV1/FVC : 50-59% (moderate)  PEF : 50-80% (yellow zone)  GUSS : 0-14 (moderate to severe dysphagia with aspiration risk).  Abnormal arterial blood gases values. The potential participants will be excluded if they meet one of the following criteria: 1. Patients who cannot follow instructions as sensory aphasia, blindness, dementia, and deafness. 2. Patients with any orthopedic, neurological, or chest disorders that affect trunk muscles control or cause respiratory disorders as COPD. 3. Patients with cognitive and psychiatric disorders. 4. Patients with unstable cardiovascular conditions. 5. Patients with contraindications to abdominal functional electrical stimulation as: • Cardiac pace maker. • Acute abdominal surgery. • Acute neck surgery • Patients with tracheostomy • Any skin diseases. 6. Patients with severe head injury. 7. Patients with Glasgow coma scale below 11. 8. Patients with paralysis of facial muscles. 9. Patients with uncontrolled diabetes and hypertension Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 55 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/10/2021 Research ethical committee of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District, Giza Governorate Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Respiratory function assessment using hand held lung function spirometry pre and post
Secondary Outcome Arterial blood gases analyzer Pre and post
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Neurological intensive care unit Nile Corniche, Al Eini, El Sayeda Zeinab, Cairo Governorate Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Zidan 4th District 6th October Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Zidan 4th District 6th October Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Zidan mohamed.said.zidan@pt.mti.edu.eg 01016469801 4th District
City Postal code Country Position/Affiliation
Giza Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Azza Fekry dr.azzafekry@yahoo.com 01003029667 4th District
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Hany Ezzat anazih@pt.mti.edu.eg 01141387006 4th District
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this study after identification (text, tables, figures, and appendices) Study Protocol two years Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information