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.: PACTR202201788162241 Date of Approval: 17/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Core Stabilization Exercise Versus Active Self-Correction Exercises in Treatment of Children and Adolescents with Idiopathic Scoliosis
Official scientific title Efficacy of Core Stabilization Exercise Versus Active Self-Correction Exercises in Treatment of Children and Adolescents with Idiopathic Scoliosis
Brief summary describing the background and objectives of the trial Background: There are several types of physiotherapeutic exercises methods used in scoliosis rehabilitation. But there is need for comparable studies on the effectiveness of different exercise approaches for the treatment of children and adolescent with idiopathic scoliosis (AIS). Objectives: Comparison of the effects of core stabilization (CS) and active self-correction (ASC) exercises treatment in patients with mild to moderate (AIS).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/02/2021
Actual trial start date 11/02/2021
Anticipated date of last follow up 22/04/2021
Actual Last follow-up date 13/05/2021
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A taken 4 sessions every week for 3 months Group(A) received CS exercises, taken 4 sessions every week 15 Active-Treatment of Control Group
Experimental Group Group B , taken 4 sessions every week for 3 months received ASC exercises 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primary curve magnitude 10°–25° Cobb angle, Risser below 2° and no previous treatment, age between9-14 years, child is able to participate throughout the study. Patients with musculoskeletal operations, tumors, any diagnosable cause of scoliosis, leg-length discrepancy of, lower limb deformities interfering with spinal curvature, evidence of congenital curve, history of spine surgery, musculoskeletal or neurological disease, spinal pathology, renal, cardiovascular, pulmonary, or vestibular diseases; or surgical correction history. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 9 Year(s) 14 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 14/12/2020 Institute of Review Board
Ethics Committee Address
Street address City Postal code Country
Zagaziq Zagazig 0002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Flexibility test (back flexion). 3 months
Secondary Outcome Quality of life (QOL): 3 months
Secondary Outcome Strength and endurance of back muscles; 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic university of Zagaziq Zagaziq Zagaziq Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Radwa Saeid Abdulrahman Giza Elzaiat 0003 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Zagaziq Zagaziq Zagazig 0002 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ezzat El Sayed Elawh Moubarak Zagazig Zagazig 0002 Egypt
Ahmed Abd el monam Zagazig Zagazig 0002 Egypt
Radwa S. Abdulrahman Zagazig Zagazig 0002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ezzat El Sayed Elawh Moubarak drezzatmoubarak@gmail.com 01153072527 Zagazig
City Postal code Country Position/Affiliation
Zagazig 0002 Egypt Doctoral Degree
Role Name Email Phone Street address
Public Enquiries Ahmed Abd Elmonaam Ahmed.abdelmanam@pt.bsu 01004896193 Zagazig
City Postal code Country Position/Affiliation
Zagazig 0002 Egypt Doctoral Degree
Role Name Email Phone Street address
Scientific Enquiries Radwa S Abdulrahman radwakku@gmail.com 0001027713662 Nozha
City Postal code Country Position/Affiliation
Cairo 0002 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the requested data and results of this research would be available after publication of the research. Statistical Analysis Plan the IPD will be available after publication. Access will by performed by a third party
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