Protocol summary
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Study aim
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To study the changes in the alignment (position of the scapula, head, shoulders and thoracic spine) and the electromyography activity of the selected muscles (upper , middle and lower trapezius, serratus anterior) and the movement patterns (Scapulohumeral rhythm and neck flexion) based on a comprehensive approach in the assessment processes, the design of their corrective exercises and their effectiveness in men with the UCS before and after an 8-week the CCEP, and 4 weeks detraining after it, examine the sustainability of the changes.
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Design
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Single-blind randomized controlled trial
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Settings and conduct
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A single-blinded randomized, controlled trial comparing a 3 times per week group exercise intervention with a control group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Non-athletic male students residing in the dormitory of Tehran University who are aged 18 to 28 years old. having scapular dyskinesis. forward head and shoulder degrees more than 46 and 52 respectively, and increased thoracic kyphosis more than 42. complete the written consent form.
Exclusion criteria: History of disease and fracture, abnormalities in the lower extremities.
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Intervention groups
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The intervention group includes those with the upper crossed syndrome who receive the intervention of a comprehensive corrective exercise program.
The control group also includes people with the upper crossed syndrome who do not receive any training intervention and follow their daily activities.
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Main outcome variables
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The alignment of head and thoracic spine with selected muscle activation
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181004041232N1
Registration date:
2018-10-26, 1397/08/04
Registration timing:
prospective
Last update:
2019-05-25, 1398/03/04
Update count:
3
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Registration date
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2018-10-26, 1397/08/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-22, 1397/10/01
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Expected recruitment end date
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2019-07-01, 1398/04/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effectiveness of a Comprehensive Corrective Exercises Program (CCEP) and subsequent detraining on alignment, muscle activation and movement pattern in men with upper crossed syndrome
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Public title
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Comprehensive Corrective Exercises and upper crossed syndrome
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
The students of the University of Tehran, Iran.
Participants who have all symptoms of UCS
Complete the written consent form
18 to 28 years of age
Exclusion criteria:
Don’t complete the corrective exercise program
Have lack of interest in continuing the research program
Have physical activity and sports
Have any visible malalignment in the pelvis and lower extremities
Have pathological signs
Have a history of fracture, surgery, or joint diseases in the spine, shoulder and pelvis
Have a body weight outside the normal range
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Age
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From 18 years old to 28 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In order to randomly assign the subjects to the intervention and control groups, one number is considered for each subject. The numbers are randomly assigned to two groups using a random number table. To conceal numbers in each group, they are written on paper, and each one is kept in a numbered sealed, opaque envelope.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-08-28, 1396/06/06
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Ethics committee reference number
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IR.ut.Rec.1395026
Health conditions studied
1
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Description of health condition studied
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Upper crossed syndrome
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ICD-10 code
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M40.04
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ICD-10 code description
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Postural kyphosis, thoracic region
Primary outcomes
1
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Description
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The position and rhythm of Scapula
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Timepoint
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Before intervention, 8 and 12 weeks after starting the intervention
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Method of measurement
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Scapular dyskinesis test
2
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Description
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Head alignment
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Timepoint
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Before intervention, 8 and 12 weeks after starting the intervention
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Method of measurement
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Photogrammetery method
3
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Description
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Thoracic kyphosis angle
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Timepoint
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Before intervention, 8 and 12 weeks after starting the intervention
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Method of measurement
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Flexicurve
4
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Description
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Electromyography of selected muscles
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Timepoint
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Before intervention, 8 and 12 weeks after starting the intervention
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Method of measurement
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Electromyography device
Intervention groups
1
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Description
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Intervention group: The intervention group will receive comprehensive corrective exercises under supervision and 3 sessions a week. The duration of the intervention period is 8 weeks.
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Category
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Prevention
2
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Description
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Control group: There is no intervention
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of Tehran
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available