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.: PACTR202107516011646 Date of Registration: 20/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Core Stabilization Exercise and Kinesio Taping on Pain, Cobb Angle and Muscle Strength and Endurance of Trunk in Children and Adolescent with Idiopathic Scoliosis
Official scientific title Effects of Core Stabilization Exercise and Kinesio Taping on Pain, Cobb Angle and Muscle Strength and Endurance of Trunk in Children and Adolescent with Idiopathic Scoliosis
Brief summary describing the background and objectives of the trial To compare the effects of Core stabilization exercise (CS) plus kinesio taping (KT) and CS alone on pain, Cobb angle and Muscle Strength and Endurance of Trunk in Children and adolescent With Idiopathic Scoliosis (AIS). Patients with AIS were randomly allocated into CS+KT group A (n: 15) and CS group B (n: 15). Pain with Visual Analog Scale, Cobb angle with loaded posteroanterior radiograph and Muscle Strength and Endurance of Trunk with Sørensen test were assessed. Both groups received 3 sessions every week for 6 weeks and KT was replaced every week for 6 weeks.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 06/03/2021
Actual trial start date 08/03/2021
Anticipated date of last follow up 16/06/2021
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 52
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
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Core Stabilization Exercise and Kinesio Taping 3 times per week 3 months Core Stabilization Exercise and Kinesio Taping 26 Active-Treatment of Control Group
Experimental Group Core Stabilization 3 times per week 3 months Core Stabilization 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
no history of spinal surgery no history of allergies KT no history of leg length discrepancy no history of cardiovascular disorder or neurological disorder no structural idiopathic scoliosis able to participate throughout the study spinal surgeries other orthopedic problems Neuorological manifestations that interferes with the intervension Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 9 Year(s) 16 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 02/03/2021 University of Zagazeeq collage of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
Zagazeeg Zagazeeq 0003 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain assessment , Cobb’s angle 3 months
Secondary Outcome Strength and endurance of back muscles 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinic in Zagazig University Zagazeeq Zagazeeg 0003 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator Dr. Ezzat el Sayed Elawah Zagazig Zagazig 0003 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Zagazeeq Zagazeeq Zagazeeq 0003 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ezzat El Sayed Eawh Moubarak Zagazig Zagazig 0003 Egypt
Mohamed Ibrahim Mohamed 7th el Zayat Giza 0003 Egypt
Radwa Saeid Abdulrahman Mahmoud 7th Al Zayat Giza 0003 Egypt
Shamaa Abdalaleem Abdalgeleel Kasr El Einy Cairo 0002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ezzat Moubarak drezzatmoubarak@gmail.com 00201153072527 7th Zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Lecturer in Department of Rheumatology and Rehabilitation
Role Name Email Phone Street address
Public Enquiries Mohamed Mohamed mipt2002@hotmai.com 00201159882370 7th Zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Lecturer in Department of Physical Therapy for Pediatrics
Role Name Email Phone Street address
Scientific Enquiries Radwa Mahmoud radwakku@gmail.com 00201027713662 7th Al Zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Lecturer in Department of Physical Therapy For Pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all Authors are obliged to provide the requested results as soon as it is available Informed Consent Form,Statistical Analysis Plan it will be available within 24 months A third party will be responsible for providing the 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