Protocol summary
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Study aim
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The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder internal impingement syndrome
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Design
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Clinical trial with a control group, with parallel groups, one-way blind, randomized, on 22 patients (2 groups of 11 people). Excel software rand function was used for randomization.
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Settings and conduct
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Neuromuscular Rehabilitation Research Center
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age 18-35 years; History of back and shoulder pain and shoulder entrapment in the past month; A non-professional athlete who exercises an average of 6 to 8 hours per week.
Exclusion criteria: People with a body mass index of more than 30; Previous history of shoulder surgery; Performed shoulder physiotherapy in the last 3 months; Shoulder deformation; Osteoporosis.
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Intervention groups
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Intervention group: In this group, athletes undergo postural post-retraining exercises with breathing according to the protocol. Exercises for 6 weeks, which are done 5 days a week and once a day and 4 times each time.
Control group: There is no intervention and it is only for comparison with the intervention group.
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Main outcome variables
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Muscles performance level; Muscle strength.
General information
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Reason for update
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Sample size correction, how to blind from two sides to one side blind
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151228025732N58
Registration date:
2020-10-26, 1399/08/05
Registration timing:
registered_while_recruiting
Last update:
2021-09-29, 1400/07/07
Update count:
2
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Registration date
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2020-10-26, 1399/08/05
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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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2020-10-06, 1399/07/15
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Expected recruitment end date
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2021-03-19, 1399/12/29
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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 effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder internal impingement syndrome
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Public title
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The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder internal impingement syndrome
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18-35 years
History of back and shoulder pain and shoulder entrapment in the past month
A non-professional athlete who exercises an average of 6 to 8 hours per week
Exclusion criteria:
People with a body mass index of more than 30
Previous history of shoulder surgery
Performed shoulder physiotherapy in the last 3 months
Shoulder deformation
Osteoporosis
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Age
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From 18 years old to 35 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
22
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 2).
Using Excel software to generate random number tables
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants are unaware of the allocation of study groups.
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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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2020-06-02, 1399/03/13
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Ethics committee reference number
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IR.SEMUMS.REC.1399.077
Health conditions studied
1
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Description of health condition studied
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Internal shoulder impingement syndrome
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ICD-10 code
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M75.40
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ICD-10 code description
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Impingement syndrome of unspecified shoulder
Primary outcomes
1
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Description
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Muscles performance level
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Timepoint
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Before the intervention, after the end of the exercise therapy sessions, one month after the end of the exercise therapy sessions.
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Method of measurement
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Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
2
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Description
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Muscle strength
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Timepoint
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Before the intervention, after the end of the exercise therapy sessions, one month after the end of the exercise therapy sessions.
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Method of measurement
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Biodex Pro-4, Isokinetic Shirley, New York
Intervention groups
1
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Description
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Intervention group: In this group, athletes undergo postural post-retraining exercises with breathing according to the protocol. Exercises for 6 weeks, which are done 5 days a week and once a day and 4 times each time.
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Category
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Rehabilitation
2
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Description
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Control group: There is no intervention and it is only for comparison with the intervention group.
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Category
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Diagnosis
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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Semnan University of Medical Sciences
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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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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available