Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201702001942264 Date of Approval: 26/12/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title THE EFFECT OF INTEGRATED EXERCISE PROGRAM VERSUS BRACING ON ADOLESCENT IDIOPATHIC SCOLIOSIS
Official scientific title THE EFFECT OF INTEGRATED EXERCISE PROGRAM VERSUS BRACING ON ADOLESCENT IDIOPATHIC SCOLIOSIS
Brief summary describing the background and objectives of the trial Adolescent Idiopathic Scoliosis (AIS) is a complex pathology with local and spinal three 3D deformities (Poncet P, etal 2001). Early detection of progression risk is essential to establish the treatment strategy (Duval-Beaupere G, 1996), but it remains challenging. Numerous studies in genetics, biology, neurosciences and biomechanics have investigated the initiation and progression of AIS (Kouwenhoven JW and Castelein RM, 2008). Progression risk assessment is mainly based on the follow-up, particularly during the growth peak, when a rapid progression can occur (Duval-Beaupere G, 1996). Many non-operative treatment options, such as physical therapy, surface electrical stimulation, and chiropractic treatment, have been proposed, but supporting data are lacking from controlled studies (M. Timothy Hresko, 2013). A commonly described prerequisite to surgical intervention is a failure of all appropriate conservative care. What exactly constitutes conservative care and the evidence for the choice is questionable. Whether the symptoms a patient is complaining about are related to the common complaints with degeneration and age or to changes related to the curve itself make treatment selection difficult. Historically, the adolescent and adult treatment options were considered together within the non-operative options despite a clear delineation within the surgical literature (Lonstein JE, 2006). Nonsurgical treatment options are commonly advocated, but no evidence to discriminate between these methods is presented (Fast A, 1999). Currently, a lack of consensus exists on the most efficacious conservative clinical treatment for adult degenerative scoliosis. The objective is to evaluate the evidence of effectiveness of potential conservative treatment options in adolescent idiopathic scoliosis (Clifford R., et al 2007).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Scoliosis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2017
Actual trial start date 01/02/2017
Anticipated date of last follow up 31/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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 Stratified allocation where factors such as age, gender, centre, or previous treatment are used in the stratification Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Integrated exercise program 2 hours/day, twice/week 12 months 20 subjects will receive the integrated exercises program for 6 months and then follow up for 6 months. The integrated exercises program consists of Schroth method, Pilates exercises, myofacial release, 3D cervical and lumbar traction. The other 20 subjects will use Boston Brace for 6 months and follow up for 6 months. Cobb¿s angle and vertebral rotation will be measured 20
Experimental Group Integrated exercise program 2 hours/day, twice/week 12 months 20 subjects will receive the integrated exercises program for 6 months and then follow up for 6 months. The integrated exercises program consists of Schroth method, Pilates exercises, myofacial release, 3D cervical and lumbar traction. Cobb¿s angle and vertebral rotation will be measured 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Forty subjects with idiopathic scoliosis with spinal curves ranged from 10°- 45° (mild to moderate). 2- Both genders. 3- Age range from 12-18 years. 1-Structural defects of the spinal vertebra. 2-Back pathology as congenital deformity. 3-Either neuromuscular or musculoskeletal diseases other than scoliosis. 12 Year(s) 18 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 01/03/2017 Cairo University
Ethics Committee Address
Street address City Postal code Country
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 01/02/2017 Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza Giza, Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cobb's angle degree after 6 months then follow up after 6 months
Primary Outcome Posture analysis for head, shoulder, rib cage and hips along with the frequency of inclinations to the left and to the right before intervention, after 6 months of intervention, after 1 year of intervention
Secondary Outcome satisfaction questionnaire to measure if patient is satisfied, feeling pain or discomfort - after 3 months of intervention - after 6 months of intervention - after 12 months of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Badr University Badr City Cairo Egypt
ARC for physiotherapy Heliopolis Cairo Egypt
Faculty of Physical Therapy, Cairo University Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ARC 10 Abu Bakr Seddik Heliopolis, Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ARC 10 Abu bakr al seddik st. Heliopolis, Cairo Egypt Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Badr University Badr City, Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Elsayed ma7moudibrahim82@gmail.com 01001234806
City Postal code Country Position/Affiliation
Cairo Egypt Teacher Assistant
Role Name Email Phone Street address
Public Enquiries Aliaa Atya aliaa.atya@pt.cu.edu.eg 01000011744
City Postal code Country Position/Affiliation
Cairo Egypt Teacher
Role Name Email Phone Street address
Scientific Enquiries Fatma Amin leaderm@msn.com 01020250400
City Postal code Country Position/Affiliation
Cairo Egypt Professor
REPORTING
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