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The Effect of 12 Weeks of Corrective Exercises on Respiratory Parameters and EMG of Selected Muscles in Adolescent Girls with Idiopathic Scoliosis

Protocol summary

Study aim
Evaluation of the effect of 12 weeks of corrective training on respiratory indices and electrical activity of selected muscles in girls with idiopathic scoliosis
Design
Clinical trial with 2 experimental and control groups, randomized by random numbers, 20 patients
Settings and conduct
Participants with idiopathic s-shaped scoliosis in the experimental group receive 40 to 60 minutes of exercise intervention three days a week for twelve weeks, and the control group does not receive any intervention and perform their daily activities. Preliminary assessments will be performed by gas analyzer spirometer and16-channel MEGAVIN electromyography in the Sports Science Laboratory of Shahid Beheshti University and will be repeated after twelve weeks of training intervention.
Participants/Inclusion and exclusion criteria
Criteria for inclusion of subjects who have reached the age of puberty, age range 11 to 17 years, idiopathic S-shaped idiopathic malformation in the lumbar thoracic region, with a normal BMI of 18 to 25 degrees of abnormality in the range of mild to moderate, willingness to participate voluntarily and non-athlete Criteria for not using braces, suffering from certain diseases such as MS, epilepsy, etc., performing surgery on the shoulder girdle, spine, pelvis and lower limbs and the actual length difference in the lower limbs
Intervention groups
The experimental correction group consists of a combination of SCHROTH, SEES, DOBOMED, FITS, Side Shift and BSPTS exercises for 12 weeks and 3 sessions per week, the first sessions lasting 40 minutes and the last progressive session lasting 60 minutes. Be. They are performed under the supervision of the researcher and the control group only performs their daily activities during these 12 weeks.
Main outcome variables
independent variable: Corrective exercises The dependent variables: Respiratory Parameters And EMG Of Selected Muscles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210928052622N1
Registration date: 2021-10-31, 1400/08/09
Registration timing: prospective

Last update: 2021-10-31, 1400/08/09
Update count: 0
Registration date
2021-10-31, 1400/08/09
Registrant information
Name
Parisa Shahrzad
Name of organization / entity
Minstry Of Science, Reasearch and Technology
Country
Iran (Islamic Republic of)
Phone
+98 34 4226 8888
Email address
p.shahrzad@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-09, 1400/11/20
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 12 Weeks of Corrective Exercises on Respiratory Parameters and EMG of Selected Muscles in Adolescent Girls with Idiopathic Scoliosis
Public title
The Effect of 12 Weeks of Corrective Exercises on Respiratory Parameters and EMG of Selected Muscles in Adolescent Girls with Idiopathic Scoliosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects have reached puberty Age range between 11 and 17 years Having S-shaped idiopathic scoliosis in the lumbar thorasic region Has a BMI of 18 to 25 Abnormal severity in the range of mild to moderate(cobb angle between 10 to 30 degrees in each curvature of the single studied) Willingnessto participate voluntarily in the present study All subjects are non-athletes
Exclusion criteria:
Use braces Have a history of surgery on the spine,shoulder gridle and pelvis and lower limbs Having a real lenght difference in the lower limb Having certain diseases (MS,epilepsy,...)
Age
From 11 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
We use the random allocation rule .In this way ,we assing a number to each subject and pour the numbers in the lottery container and without substitution,we randomly take out the numbers and the first 10 numbers in the experimnetal group and the remaining 10 numbers.We put it in the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees Of Shahid Beheshti University
Street address
Unit 6, No.8, Mahoutchi St, Kachuei St, Evin
City
Tehran
Province
Tehran
Postal code
1983655398
Approval date
2021-05-22, 1400/03/01
Ethics committee reference number
IR.SBU.REC.1400.067

Health conditions studied

1

Description of health condition studied
S- shaped idiopathic scoliosis
ICD-10 code
M41.12
ICD-10 code description
Adolescent scoliosis

Primary outcomes

1

Description
Respiratory parameters
Timepoint
Pre-test is performed at the beginning of the study and before the intervention and post-test 12 weeks after the intervention.
Method of measurement
Metalyzer 3BR2 gas analyzer

2

Description
EMG Of selected muscle
Timepoint
Pre-test is performed at the beginning of the study and before the intervention and post-test 12 weeks after the intervention.
Method of measurement
16-chanells megaWin ME6000 electromyography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Performing 12 weeks of corrective exercises selected from the best scoliosis treatment exercises, including SCHROTH, SEES, BSPS, FITS, DOBOMED and Side Shift, which are performed under the supervision of the researcher according to the characteristics of the subject and the principle of overload. Exercise in the first sessions is 40 minutes, which will progressively reach 60 minutes in the last sessions. In all movements, the emphasis is on proper breathing during exercise.
Category
Treatment - Other

2

Description
Control group: Perform your daily activities
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Red Crescent Rehabilitation Center
Full name of responsible person
Mehdi Gheitasi
Street address
Next to Khatam Al-Anbia Hospital, Rashid Yasemi st, Valiasr st
City
Tehran
Province
Tehran
Postal code
1996835611
Phone
+98 21 8820 1241
Email
Mehdi.gheitasi@googlemail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University Of Shahid Beheshti
Full name of responsible person
Babak Shokri
Street address
Shahid Shahriari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Email
Parisashahrzad2001@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University Of Shahid Beheshti
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Shahrzad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Unit 6, No.8, Mahutchi st, Kachuii st, Evin
City
Tehran
Province
Tehran
Postal code
1983655398
Phone
+98 21 2241 2082
Email
Parisashahrzad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Shahrzad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Unit 6, No.8, Mahutchi st, Kachuii st, Evin
City
Tehran
Province
Tehran
Postal code
1983655398
Phone
+98 21 2241 2082
Email
Parisashahrzad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Shahrzad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Unit 6, No.8, Mahutchi st, Kachuii st, Evin
City
Tehran
Province
Tehran
Postal code
1983655398
Phone
+98 21 2241 2082
Email
Parisashahrzad@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after unidentified individuals
When the data will become available and for how long
After publishing
To whom data/document is available
Students and researchers
Under which criteria data/document could be used
researches
From where data/document is obtainable
Parisashahrzad@yaho.com
What processes are involved for a request to access data/document
After sending email
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