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.: PACTR202203828186104 Date of Registration: 30/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title INFLEUNCE OF SCHROTH THERAPY ON VENTILATORY FUNCTION IN ADOLESCENT IDIOPATHIC SCOLIOSIS
Official scientific title INFLEUNCE OF SCHROTH THERAPY ON VENTILATORY FUNCTION IN ADOLESCENT IDIOPATHIC SCOLIOSIS
Brief summary describing the background and objectives of the trial Nonsurgical treatment options are commonly advocated, but no evidence to discriminate between these methods is presented (Everett & Patel, 2007). Currently, a lack of consensus exists on the most efficacious conservative clinical treatment for AIS. The objective is to evaluate the evidence of effectiveness of potential conservative treatment options in AIS (Negrini et al., 2006). Respiratory disorders and exercise intolerance are common complications of AIS secondary to weakness of respiratory muscles and reduced lung capacity (Martinez-Liorens et al., 2010) Does Schroth exercises affect pulmonary function in adolescent idiopathic scoliosis?
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 Education /Training
Anticipated trial start date 01/04/2022
Actual trial start date 01/04/2022
Anticipated date of last follow up 01/10/2022
Actual Last follow-up date 31/12/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Active, not 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 randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Schroth exercises two times per week 18 weeks Group A will receive Schroth exercises which consists of: - Self-Correction exercises - Rotational Angular Breathing exercises Group B will receive Traditional exercises which consists of: -Therapeutic exercises: stretching exercises for concave side and strengthening exercises for convex side. -Hanging on wall Bar -Cat position 30
Control Group Traditional exercises twice per week 18 weeks Group A will receive Schroth exercises which consists of: - Self-Correction exercises - Rotational Angular Breathing exercises Group B will receive Traditional exercises which consists of: -Therapeutic exercises: stretching exercises for concave side and strengthening exercises for convex side. -Hanging on wall Bar -Cat position 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Sixty subjects with idiopathic scoliosis with spinal curves ranged from 25°- 45° (moderate). 1- Females 2- Age range from 12-18 years. 1- Other structural defects of the spinal vertebra rather than scoliosis. 2- Other neuromuscular or musculoskeletal diseases other than scoliosis. 3- Obese subjects with Body Mass index above 25. Adolescent: 13 Year-18 Year 12 Year(s) 18 Year(s) Female
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 30/04/2022 cairo university
Ethics Committee Address
Street address City Postal code Country
cairo cairo 20620 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pulmonary function 18 weeks
Secondary Outcome Height and weight 18 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Badr university cairo cairo 20620 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo university Giza Egypt Egypt 12422 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alaa new cairo new cairo 20620 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Ibrahim Elsayed ma7moudibrahim82@gmail.com 01011967400 new cairo
City Postal code Country Position/Affiliation
new cairo 20620 Egypt supervisor
Role Name Email Phone Street address
Public Enquiries Awny Fouad Rahmy awnyrahmy@gmail.com 01210310367 new cairo
City Postal code Country Position/Affiliation
new cairo 20620 Egypt professor
Role Name Email Phone Street address
Principal Investigator Akram Abdelaziz akramabdelaziz@gmail.com 0122736206 new cairo
City Postal code Country Position/Affiliation
new cairo 20620 Egypt Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: “Yes” Plan Description: “Data obtained through this study may be provided to qualified researchers with academic interest in idiopathic scoliosis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. As from may 2022 to march 2024 Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
clinicalresearchsupportcenter@ucdenver.edu 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