Protocol summary
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Study aim
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Comparison of scapular stability exercises and the combination of chain exercises and scapular stability exercises in patients with shoulder impingement syndrome
If the results of the study show that adding components of the movement chain to scapular stability exercises can provide more recovery for these patients, we will emphasize more on this model of exercise therapy for these patients.
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Design
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A double-blind randomized controlled clinical trial. Randomization is done using a sealed envelope.
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Settings and conduct
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The assessment process is taught to the patients by the physiotherapist at the Diani Physiotherapy Clinic or the Rehabilitation Faculty of Tehran University. Evaluation is done only in the first session and at the end of the fourth week. The remaining sessions (12 sessions in total) are limited to exercises (8 exercises). The patients and the evaluator do not know about the grouping of the participants.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Men and women amateur athletes of overhead sports (volleyball, basketball, handball, badminton, tennis) with shoulder impingement syndrome (Neer classification stage 1 and 2)
Age range from 17 to 45 years
Exclusion criteria:
Having a history of surgery, fracture, dislocation in the shoulder area in the last 12 months
The presence of grade 3 tears in the rotator cuff muscles
Type 3 acromion
Adhesive capsulitis of the shoulder
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Intervention groups
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scapular stability exercises (control group)
scapular stability exercises with the addition of chain components (intervention group)
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Main outcome variables
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scapula rest position
pain (VAS)
Functional disability of the shoulder (DASH)
Upper limb closed chain function
General information
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Reason for update
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Dear Sir/Madam,
The actual start date and the sampling date have been entered. We kindly request that you review them.
Thank you
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240614062130N1
Registration date:
2024-07-20, 1403/04/30
Registration timing:
prospective
Last update:
2026-08-31, 1405/06/09
Update count:
1
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Registration date
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2024-07-20, 1403/04/30
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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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2024-07-20, 1403/04/30
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Expected recruitment end date
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2024-10-21, 1403/07/30
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Actual recruitment start date
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2024-08-15, 1403/05/25
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Actual recruitment end date
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2024-12-28, 1403/10/08
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Trial completion date
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2024-12-28, 1403/10/08
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Scientific title
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Comparison of kinetic chain exercises and scapula stabilization exercises on rest position of scapula, pain and function of shoulder in overhead athletes with impingement syndrome
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Public title
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The effect of motor chain exercises with scapular stability exercises on scapular resting state, pain and shoulder function in overhead athletes with shoulder impingement syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Amateur male and female athletes in overhead sports (volleyball, basketball, handball, badminton, tennis) with shoulder impingement syndrome (Neer classification stage 1 and 2)
The patient's chief complaint in the glenohumeral area or the proximal part of the arm for at least 4 weeks
Positive at least 3 tests from Neer, Job, Hawkins, resisted external rotation and painful arch tests
Shoulder pain with intensity between 3 and 7 based on VAS in one of the resistance tests of internal rotation, external rotation, flexion or abduction
Absence of movement limitation of more than one third of the healthy side in raising the shoulder or at least a range of 150 degrees of elevation
Exclusion criteria:
Presence of neurological problems/pains originating from the cervical spine, systemic and rheumatological problems
Receiving other treatments (such as corticosteroid injections) in at least one last month
Adhesive capsulitis of the shoulder
Type 3 Acromion
The presence of grade 3 tears in the rotator cuff muscles
Having a history of surgery, fracture, dislocation in the shoulder area in the last 12 months
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Age
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From 17 years old to 45 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:
24
Actual sample size reached:
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 the first assessment session, the names of groups 1 (scapular stability exercises - control group) and 2 (scapular stability exercises with the addition of chain movement exercises - intervention group) are written on 12 sheets for each group and placed inside a sealed envelope. In this way, there will be 24 envelopes (12 envelopes containing the number 1 and 12 envelopes containing the number 2). Participants randomly pick one of the envelopes and give it to the therapist.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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None of the referring people were aware of the existence of two treatment groups and the people were informed that during this research, the process of therapeutic exercise will be applied to them in order to reduce pain.
The evaluation will be done by a person who does not know the contents of the envelopes and the grouping of patients.
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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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2023-07-18, 1402/04/27
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Ethics committee reference number
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IR.TUMS.FNM.RES.1402.099
Health conditions studied
1
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Description of health condition studied
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Impingement syndrome of shoulder
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ICD-10 code
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M75.4
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ICD-10 code description
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Impingement syndrome of shoulder
Primary outcomes
1
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Description
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"Pain intensity" using a visual analog scale
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Timepoint
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At the beginning of the study and after completing 12 training sessions
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Method of measurement
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Pain intensity will be evaluated using a visual analog scale at rest, in active abduction and flexion movements.
2
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Description
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Functional disability of the upper limb by the Persian version of Disabilities of the Arm, Shoulder and Hand questionnaire
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Timepoint
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At the beginning of the study and after completing 12 training sessions
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Method of measurement
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The score of the Persian version of the questionnaire related to the degree of disability of the shoulder (Disabilities of the Arm, Shoulder and Hand)
3
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Description
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Evaluation of the performance related to the upper limb closed movement chain by the average number of contacts in Closed Kinetic Chain Upper Extremity Stability Test
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Timepoint
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At the beginning of the study and after completing 12 training sessions
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Method of measurement
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Counting the average number of contacts in 15 seconds in Closed Kinetic Chain Upper Extremity Stability Test
4
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Description
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Evaluation of the performance of the closed movement chain in the upper limb by reaching distance in Upper Quarter Y-Balance Test in medial, superior-lateral and inferior-lateral directions
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Timepoint
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At the beginning of the study and after completing 12 training sessions
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Method of measurement
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Upper Quarter Y-Balance Test
5
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Description
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Upward/downward rotation angles of the scapula
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Timepoint
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At the beginning of the study and after completing 12 training sessions
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Method of measurement
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Gravity reference inclinometer
6
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Description
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Angle of Anterior/Posterior inclination of the scapula
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Timepoint
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At the beginning of the study and after completing 12 training sessions
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Method of measurement
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Gravity reference inclinometer
Secondary outcomes
1
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Description
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The distance between the inferior angle of the scapula and the spinous process of the closest adjacent vertebra, in three positions: in neutral position, at 40-45 degrees of shoulder abduction in the frontal plane and also at 90 degrees of shoulder abduction while the arm is in full internal rotation. .
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Timepoint
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At the beginning of the study and after the completion of 12 training sessions
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Method of measurement
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Using a tape measure in the Lateral Scapular Slide Test
Intervention groups
1
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Description
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Control group: performing 12 sessions of shoulder stabilization exercises as follows: Serratus anterior punch/Scapular retraction/Scapular retraction with adduction hold/Wall slide with Thera-band-at-wrist/D2-PNF pattern/Sleeper Stretch/Modified Cross body stretch/ Corner Stretch
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Category
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Rehabilitation
2
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Description
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Intervention group: performing 12 sessions of scapular stability exercises with the addition of movement chain components as follows: Forward Punch Plus with forward step/Fencing/Scapular retraction with adduction plus contralateral one leg squat/Wall slide with Thera-band-at-wrist plus squat /Reverse throw/Sleeper Stretch/Modified Cross body stretch/Corner Stretch
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Category
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Rehabilitation
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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Tehran 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is 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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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The data of this study will be placed in the form of 24 separate participants, each of which has 30 variables. 15 of the variables are related to the first stage of evaluation and 15 are related to the second stage of evaluation, after the interventions.
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When the data will become available and for how long
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Access will be provided after printing the results
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To whom data/document is available
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People who are active in the field of physical therapy and sports and other aspiring researchers
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Under which criteria data/document could be used
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The use of data is unhindered by mentioning the source.
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From where data/document is obtainable
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email address: sayeh_moosavi183@yahoo.com
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What processes are involved for a request to access data/document
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email address: sayeh_moosavi183@yahoo.com
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Comments
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