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.: PACTR202006869392862 Date of Approval: 02/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative efficacy of trans cranial direct current stimulation and conventional therapy in post thermal inhalation dysphagic children and adult patients: A randomized controlled trial
Official scientific title trans cranial direct current stimulation and conventional therapy in post thermal inhalation dysphagic patients
Brief summary describing the background and objectives of the trial the current study aimed to investigate the effect of adding Trans cranial direct current stimulation (tDCS) to the conventional therapy of treating post thermal inhalation injury dysphagia. Methods: Thirty patients complaint from post thermal inhalation injury dysphagia were participated in this study, their ages were ranged from 13 to 60 years. They were randomly divided into two equal groups. Group (A): Received 3 weeks of treatment with (tDCS), 2-mA current was delivered for only 30 s through 2 surface electrodes three times/week in addition to the conventional therapy. While Group (B): Received 3 weeks of treatment with conventional physical therapy plus sham (tDCS). Functional Oral Intake Scale (FOIS) and The Mann Assessment of Swallowing Ability (MASA) were used to assess the swallowing ability in both groups before and after the intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 27/03/2020
Actual trial start date 01/04/2020
Anticipated date of last follow up 21/04/2020
Actual Last follow-up date 01/05/2020
Anticipated target sample size (number of participants) 65
Actual target sample size (number of participants) 60
Recruitment status Completed
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 randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Transcranial Direct Current Stimulation 3 weeks Received 3 weeks of treatment with (tDCS), 2-mA current was delivered for only 30 s through 2 surface electrodes three times/week in addition to the conventional therapy 30
Control Group Conventional physical therapy Received 3 weeks of treatment with conventional physical therapy plus sham (tDCS). Functional Oral Intake Scale (FOIS) and The Mann Assessment of Swallowing Ability (MASA) were used to assess the swallowing ability in both groups before and after the intervention. Received 3 weeks of treatment with conventional physical therapy plus sham (tDCS). Functional Oral Intake Scale (FOIS) and The Mann Assessment of Swallowing Ability (MASA) were used to assess the swallowing ability in both groups before and after the intervention. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
post thermal inhalation dysphagia patients, from both sexes, were included in this study. All of them were cooperative previous complain of dysphagia prior to the thermal inhalation injury Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 Year(s) 60 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 31/03/2019 Faculty of Physical Therapy Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elziat Giza 0025 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Video flurescopy after 3 weeks of interventions
Secondary Outcome Functional Oral Intake Scale (FOIS) and The Mann Assessment of Swallowing Ability (MASA) were used to assess the swallowing ability in both groups before and after the intervention. at the beginning of the study and at the end of the 3 weeks of interventions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Burn department at Cairo university hospital Cairo Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Ebrahim Elerian 46 b at 77 street at Elmaadi Zone Cairo 0025 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Ebrahim Elerian Elmaddi Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Nabil Mahmoud Elmaadi Cairo Egypt
Ayman Elmakiki Elmaadi Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elerian Elerian dr_ahmed_elerian77@yahoo.com 00201116752333 Elmaadi
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor at Basic science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Ayman Elmakaki aymanmakai@gmail.cim 00201116752333 Elmaadi
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer at physical therapy department for surgery Faculty of physical therapy South Valley University
Role Name Email Phone Street address
Scientific Enquiries Nabil Mahmoud dr.NabilMahmoud@gmail.com 00201116752333 Elmaadi
City Postal code Country Position/Affiliation
Cairo 0025 Egypt Lecturer at Basic Science Department Faculty of physical therapy Cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data collected from this study, including identified individual participant data, will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. The study protocol, statistical analysis plan, are available on ClinicalTrials.gov. Clinical Study Report,Statistical Analysis Plan,Study Protocol within one year publication of the primary outcomes of the study Closed Criteria , study results and report, third part ( the publisher)
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