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.: PACTR202205671719231 Date of Approval: 13/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARISON BETWEEN PILATES EXERCISES AND SCHROTH METHOD ON PATIENTS WITH UPPER CROSS SYNDROME
Official scientific title COMPARISON BETWEEN PILATES EXERCISES AND SCHROTH METHOD ON PATIENTS WITH UPPER CROSS SYNDROME
Brief summary describing the background and objectives of the trial The purpose of the study is to determine: • the effect of Pilates exercise versus Schroth method to obtain the best improvement in patients with upper cross syndrome on balance. BACKGROUND: Upper crossed syndrome (UCS) is a most common postural dysfunction in the musculature of the shoulder girdle /cervicothoracic region, which creates joint dysfunction, particularly at the atlanto-occipital joint, cervicothoracic joint C4-C5 segment, glenohumeral joint and T4-T5 segment. Pilates is designed as a program that will work in conjunction with other exercise programs to strengthen, rebalance and realign the body. Pilates trains the individuals to identify their own musculoskeletal strengths and weaknesses and equips them with the knowledge to correct and rebalance their entire body mechanics (Worth,2004) thus, the focus is also placed on improving personal body awareness which further decreases the risks of strain or injury that can occur with imbalances (Worth, 2004). There are no studies comparing pilates exercise and the Schroth method on the upper cross syndrome, so this study will be conducted to know the effective method of treatment for the upper cross syndrome
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 30/05/2022
Actual trial start date
Anticipated date of last follow up 15/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 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 postural correction exercises twice weekly for four weeks postural correction exercises to stretch and exercises to the pectoralis major, elevator scapulae, upper trapezius, serratus anterior, rhomboids, and deep neck flexors. 20 Active-Treatment of Control Group
Experimental Group Pilate exercises twice weekly for four weeks postural correction exercises in addition to Pilate exercises 20
Experimental Group Schroth three dimensional exercise twice weekly for four weeks postural correction exercises in addition to the Schroth three-dimensional exercise 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: o The patient's ages ranged from 17 to 22 years.(Rajalaxmi ,et al,2018) o Body mass index between 20-25 kg/m2(Rajalaxmi,et al,2018). o The participants are diagnosed with the upper cross syndrome. (Liebenson, 1996). o Patients with normal cognitive aspects are willing and able to participate in a program safely. (Moore,2004). Exclusion Criteria: o The participants have experienced any recent trauma (within 3 months of the initial consultation) (Rajalaxmi, et al,2018). o The participant’s primary complaint is headaches or facial pain. (Seth, 1999). o Contra-indications to pilates are found in pregnancy, hypertension, osteoporosis, and spinal tumors. (Rajalaxmi, et al,2018) o Participants have any sort of structural abnormality in the upper and middle back e.g., Scoliosis, or had a positive Adams test. (Gatterman, 1990). o Participants who are taking anti-inflammatory or muscle relaxant medication had to have a three-day “wash out” period before participating in the study(Seth, 1999). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 17 Year(s) 22 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 07/11/2021 Faculty of physical therapy Cairo University.
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzyat street Cairo 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Biodex balance system before and after intervention
Secondary Outcome Visual analogue scale to assess the pain Before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Deraya University 70 ahmed sedeek street Minya Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Jermeen EmadAbd El Massih Yousef 28 General Minya Hospital street Minya Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Deraya University 70 ahmed sedeek street Minya Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jermeen Emad Abd ElMassih Yousef germeen.emad@deraya.edu.eg 01221369998 28 General Minya Hospital street
City Postal code Country Position/Affiliation
Minya Egypt Assistant lecturer Basic Science Faculty of physical therapy Deraya University.
Role Name Email Phone Street address
Public Enquiries Rania Nagy rania.nagy@pt.cu.edu.eg 00201227244630 31 port said street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Neveen AbdelLatif AbdelRaoof dr_neveen_69@yahoo.com 01064615553 12 Mourad street
City Postal code Country Position/Affiliation
Giza Egypt Professor and Vice Dean of faculty of physical therapy for Education and students Affairs Cairo university.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Informed Consent Form,Study Protocol 12 months period time after publication Controlling access to data
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