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.: PACTR201710002724163 Date of Approval: 26/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Transcutaneous Electrical Nerve Stimulation and Conventional Therapy in Post-stroke Dysphagic Patients: A Randomized Controlled Trial
Official scientific title Effect of Transcutaneous Electrical Nerve Stimulation and Conventional Therapy in Post-stroke Dysphagic Patients: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Dysphagia is a commonly documented morbidity after stroke, In the context of stroke, oropharyngeal dysphagia is best defined as a disruption of bolus flow through the mouth and pharynx (Singh S.,2006). Conventional therapy for dysphagia typically employs both compensatory strategy techniques and specific techniques aimed at improving the coordination and strength of the swallowing muscles. (Odderson, 1995) Compensatory swallow techniques such as the effortful swallow aim to increase the efficacy and safety of swallowing.) Rehabilitation techniques such as oral and lingual exercises tend to focus on strength and endurance Treatments aimed at improving coordination and strength include Transcutaneous electrical stimulation has also been used as a sensory strategy, avoiding muscle contraction during the treatment (Gallas S.,2010). This stimulation strategy has shown significant improvement in several swallow parameters, such as reduced swallow response time and prevalence of aspirations in chronic post-stroke dysphagic patients (Rofes L.,2013).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Dysphagia After Brain Stroke,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2017
Actual trial start date
Anticipated date of last follow up 31/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TENS 3 Times per week 3 Weeks TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION 15
Experimental Group TENS+ Conventional Treatment 3 Times per week 3 Weeks 15
Experimental Group Conventional Treatment 3 Times per week 3 Weeks Swallowing Exercise + 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Patients¿ ages range from 45 to 70 years from both sexes. 2. Dysphagia following ischemic stroke 3-Acute dysphagia less than 1 month with medically stable condition confirmed by the neurologist. 4-Patients with sufficient cognitive abilities that enables them to understand and follow instructions 1. Hemorrhagic stroke patients. 2. Difficulty in swallowing prior to the incidence of neurological disorder 3.Uncooperative patients or cognitive impairment 4. Subjects with pacemakers, metal implants or orthotics, Skin breakdown around neck. 5. Seizure disorders 6. Pregnancy 7. Head and neck cancer. 8. Highly agitated patients or syncope 45 Year(s) 70 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
No 31/10/2017 Physical therapy Faculty,Cairo University , Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty Of Physical Therapy Giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Body Weight 1.Before the first treatment session 2.After 1 month of the first treatment session
Primary Outcome Swallowing Function Before The First Treatment Session. After the Last Treatment Session.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Taheal Rehablitaion Center 19 Tag El Din El Sobky Nasr City Egypt
Taheal Rehablitaion Center 66 street from 90 street 5th Settlement, New Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Taheal Rehablitation Center Nasr City Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Taheal Rehablitation Center 19 Tag el Din El Sobkhy street Nasr City Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Rami Maged Azizia Village Badrashen 12937 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rami Maged ramimaged@hotmail.com +201220690639 Azizia Village, Beside Sisi Bridge
City Postal code Country Position/Affiliation
Badrashen 12937 Egypt Physiotherapist
Role Name Email Phone Street address
Public Enquiries Tamer Emara ramimaged@gmail.com +20 106 118 6654 20 Mohamed Fouad street
City Postal code Country Position/Affiliation
Masr El Gedida Egypt Assistant Professor, Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Ahmed Ebrahim dr_ahmed_elerian77@yahoo.com +20 111 675 2333 15 street from El Thrier street
City Postal code Country Position/Affiliation
Doki Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Tamer Emara ramimaged@gmail.com +20 106 118 6654 20 Mohamed Fouad street
City Postal code Country Position/Affiliation
Masr El Gedida Egypt Assistant Professor, Faculty of Medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information