<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20260727070383N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-03</date_registration>
      <primary_sponsor>shahid beheshti University</primary_sponsor>
      <public_title>Effect of Thrower's Ten Exercise Program on Performance and Shoulder Injury Prevention in Volleyball Players</public_title>
      <acronym></acronym>
      <scientific_title>The effect of six weeks of Thrower's Ten program on performance indicators and shoulder injuries prevention in Premier League volleyball players: randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92181</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization Method:
Simple randomization with a 1:1 allocation ratio will be used.

Unit of Randomization:
The unit of randomization is individual; each participant will be independently assigned to either the experimental or control group.

Stratification:
Due to the relative homogeneity of the target population (male Premier League volleyball players aged 18–30) and the use of simple randomization, no stratified randomization will be performed.

Randomization Tool and Sequence Generation:
The random allocation sequence will be generated using specialized randomization software (Random Allocation Software version 2.0 / Sealed Envelope). After entering the participant's demographic data and unique code, the software will automatically generate a random sequence assigning each individual to either the intervention or control group.

Allocation Concealment:
To ensure allocation concealment and prevent selection bias, the Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) method will be employed. The allocation codes generated by the software will be placed in identical, opaque, sealed envelopes numbered sequentially (1 to 40). These envelopes will be prepared and kept by a third party not involved in the assessment or intervention process. The envelopes will be opened sequentially only after the completion of baseline (pre-test) assessments for each participant, Blinding description: Blinding Description:
Due to the nature of the exercise-based intervention, it is not feasible to blind the participants or the intervention providers (principal investigator and coaches). However, to minimize detection bias, the outcome assessor and the statistician will be blinded to group allocation.

Participants: Not blinded (aware of their allocated group due to the nature of the warm-up protocol).

Intervention Providers (Principal Investigator/Coaches): Not blinded (supervise the execution of the specific exercises).

Outcome Assessor: Fully Blinded. All pre- and post-intervention assessments (ROM, Joint Position Sense, UQYBT, Medicine Ball Throw, and Serve Accuracy) will be performed by an independent assessor who has no knowledge of the participants' group assignments. Participants will be instructed not to reveal their training protocol to the assessor.

Data Analyst: Blinded. Data will be analyzed using coded groups (e.g., Group A vs. Group B) until the final statistical analysis is completed. The allocation codes will be revealed only after the main analysis is finalized.

Support Staff/Data Collectors: Blinded to group allocation.

Overall, this trial is classified as a Single-Blind (Assessor-Blind) randomized controlled trial.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Shoulder injuries in volleyball players.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group perform the Thrower's Ten exercise program for 6 weeks, 4 sessions per week (total of 24 sessions), 10–15 minutes per session, as part of their warm-up before the main volleyball training. The program consists of 6 main exercises:Diagonal Pattern D2 Extension (with elastic resistance band)Diagonal Pattern D2 Flexion (with elastic resistance band)External Rotation at 15° Abduction (with resistance band or light dumbbell)Internal Rotation at 45° Abduction (with resistance band or light dumbbell)Prone Rowing (with resistance band)Scaption with External Rotation (with light dumbbell)Equipment used: Elastic resistance bands (light to medium resistance) and dumbbells weighing 1 to 3 kilograms.Progressive overload: Exercise intensity is progressively increased based on the Borg Rating of Perceived Exertion scale (score 5 to 9). In weeks 1 to 4, the number of sets increases from 3 to 4 and repetitions from 10 to 12. Week 5 is considered a deload week with reduced volume and intensity. Week 6 continues with moderate to high intensity.Supervision: The principal investigator supervises each session to ensure correct exercise technique, form, and full range of motion. Intervention 2: Control group: Participants in this group continue their usual daily warm-up routine for 6 weeks (4 sessions per week) without receiving any additional structured intervention (prevention or rehabilitation exercises). The routine warm-up includes general movements such as light jogging, static and dynamic stretching for upper and lower extremities, and general volleyball preparation exercises (including passing, serving, and light spiking) for 10–15 minutes. This group receives no specific shoulder or rotator cuff exercises. After the study completion and if the intervention proves effective, the Thrower's Ten program will also be offered to this group.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
De-identified individual participant data including demographic information (age, height, weight, sports history), as well as all raw data related to primary outcome variables (scores of explosive power, serve accuracy, functional stability, range of motion, and joint position sense tests) after complete anonymization.

When:
Three months following publication of the main results.
Up to two years after publication of the main results.

To whom:
Data and documents from this study will be available to all researchers affiliated with academic, research, and scientific institutions (both public and private), as well as clinical specialists (physiotherapists, sports medicine physicians) and sports coaches who provide a methodologically sound proposal and demonstrate the capacity to analyze data related to sports pathology and corrective exercises. Access for individuals working in the industry sector (e.g., sports equipment manufacturers) is also possible upon submission of a valid research proposal and approval by the ethics committee.

Conditions:
Permitted Purpose of Data/Document Usage:
Data and documents from this study will be made available exclusively for scientific research and educational purposes in the fields of sports pathology, corrective exercises, shoulder injury prevention, and sports biomechanics. Any commercial use, legal use, or attempts at participant re‑identification are strictly prohibited.

Conditions for Data/Document Usage:

Submission of a formal written request to the principal investigator (corresponding author), including the title and objectives of the proposed analysis.

Provision of a methodologically sound analytical proposal (specifying variables, statistical tests, and software to be used).

Obtaining ethics committee approval from the requesting institution (if applicable).

Signing a data confidentiality agreement, in which the requester commits to:

Using the data solely for the approved purposes.

Refraining from any attempt to re‑identify participants.

Not sharing the data with third parties without the principal investigator's written permission.

Not using the data for commercial or for‑profit purposes.

Acknowledging the data source (citing the main research article and this proposal) in all publications and reports resulting from the received data.

Providing a summary report of their analytical findings to the principal investigator upon completion of the analysis.

Where to obtain:
1. Email (First Priority)
Name: Dr. Amirhossein Barati (Supervisor and Principal Investigator)
Email Address: ah_barati [at] sbu.ac.ir
2. Postal Mail (Second Priority)
Name: Dr. Amirhossein Barati
Faculty: Faculty of Sport Sciences and Health, Shahid Beheshti University
Address: Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran, Iran
Postal Code: 1983969411
3. Telephone Contact (Third Priority)
Faculty Phone Number: +98-21-29905824 (extension to the Faculty of Sport Sciences and Health)

How to obtain:
Step 1: Initial Request (Days 1–3)

The applicant sends a formal email to the principal investigator (Dr. Amirhossein Barati).

The email must include: request title, analytical proposal (objectives, variables, statistical methods, and proposed software), and identification documents proving organizational affiliation.

Step 2: Initial Review by Principal Investigator (Days 4–7)

The principal investigator reviews the request for completeness of documents and scientific validity of the proposal.

If modifications or additional documents are required, the applicant will be asked to submit revisions within 5 working days.

Step 3: Submission of Commitment and Confidentiality Forms (Days 8–10)

After initial approval, the principal investigator sends the Data Confidentiality Agreement and the Formal Data Access Request Form to the applicant.

The applicant must sign and return these forms, along with their institution's ethics committee approval (if required).

Step 4: Final Review by the Data Access Committee (Days 11–14)

In this study, the Data Access Committee consists of the principal investigator, the advisor (if any), and an independent faculty member from the Faculty of Sport Sciences and Health.

This committee reviews the final request for alignment with the main study objectives and absence of conflicts of interest, and issues final approval.

Step 5: Data Preparation and Delivery (Days 15–21)

After final approval, the principal investigator de-identifies the requested data (removing all identifying information) and sends the data files (in Excel or CSV format) along with a Data Dictionary via email or a secure file-sharing link.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirhossein barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۳۹۶۹۴۱۱</zip>
        <telephone>+98 21 0000 0000</telephone>
        <email>ah_barati@sbu.ac.ir</email>
        <affiliation>shahid beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirhossein barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۳۹۶۹۴۱۱</zip>
        <telephone>21 0098 0000000</telephone>
        <email>ah_barati@sbu.ac.ir</email>
        <affiliation>Sahid beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Voluntary consent to participate in the research.
Male volleyball players with at least 2 years of regular training history in volleyball (at least 3 sessions per week).
Age between 18 and 30 years.
No severe injury (more than three weeks of absence from sports) in the past six months.
No history of fracture or surgery in the shoulder or upper extremity that would affect shoulder joint function.
No medication use, such as local steroid injection, in the past month.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unwillingness to continue participation in the research.
Absence in 3 consecutive sessions (during the protocol implementation).
Absence in the pre-test or post-test.
Occurrence of any injury during the research implementation.
Performing any injury prevention or rehabilitation exercises outside the research program during the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in this group perform the Thrower's Ten exercise program for 6 weeks, 4 sessions per week (total of 24 sessions), 10–15 minutes per session, as part of their warm-up before the main volleyball training. The program consists of 6 main exercises:Diagonal Pattern D2 Extension (with elastic resistance band)Diagonal Pattern D2 Flexion (with elastic resistance band)External Rotation at 15° Abduction (with resistance band or light dumbbell)Internal Rotation at 45° Abduction (with resistance band or light dumbbell)Prone Rowing (with resistance band)Scaption with External Rotation (with light dumbbell)Equipment used: Elastic resistance bands (light to medium resistance) and dumbbells weighing 1 to 3 kilograms.Progressive overload: Exercise intensity is progressively increased based on the Borg Rating of Perceived Exertion scale (score 5 to 9). In weeks 1 to 4, the number of sets increases from 3 to 4 and repetitions from 10 to 12. Week 5 is considered a deload week with reduced volume and intensity. Week 6 continues with moderate to high intensity.Supervision: The principal investigator supervises each session to ensure correct exercise technique, form, and full range of motion.</i_keyword>
      <i_keyword>Control group: Participants in this group continue their usual daily warm-up routine for 6 weeks (4 sessions per week) without receiving any additional structured intervention (prevention or rehabilitation exercises). The routine warm-up includes general movements such as light jogging, static and dynamic stretching for upper and lower extremities, and general volleyball preparation exercises (including passing, serving, and light spiking) for 10–15 minutes. This group receives no specific shoulder or rotator cuff exercises. After the study completion and if the intervention proves effective, the Thrower's Ten program will also be offered to this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Unilateral seated medicine ball throw test with a two‑kilogram ball (maximum throwing distance in centimeters). Timepoint: at two time points:Pre-test: Three days before the start of the intervention (in two separate sessions with a 24‑hour interval to prevent fatigue)Post-test: Three days after the completion of the 6‑week intervention period. Method of measurement: Upper limb explosive powerUnilateral seated medicine ball throw test with a two‑kilogram ball (maximum throwing distance in centimeters).</prim_outcome>
      <prim_outcome>Volleyball serve accuracyMeasured by the AAHPER volleyball serve accuracy test (10 serves from the baseline) with scoring based on 4–1 zone system (maximum score 40). Timepoint: at two time points:Pre-test: Three days before the start of the intervention (in two separate sessions with a 24‑hour interval to prevent fatigue)Post-test: Three days after the completion of the 6‑week intervention period. Method of measurement: Volleyball serve accuracyAmerican Alliance for Health, Physical Education, Recreation and Dance volleyball serve accuracy test consisting of ten serves from the baseline with scoring based on zones one to four (maximum score of forty).</prim_outcome>
      <prim_outcome>Shoulder joint stability and functional stabilityMeasured by the Upper Quarter Y-Balance Test (UQYBT) in three directions (superolateral, medial, inferolateral), normalized to upper limb length (%). Timepoint: at two time points:Pre-test: Three days before the start of the intervention (in two separate sessions with a 24‑hour interval to prevent fatigue)Post-test: Three days after the completion of the 6‑week intervention period. Method of measurement: Shoulder joint stability and functional stabilityUpper Quarter Y‑Balance Test in three directions (superolateral, medial, and inferolateral) normalized to upper limb length (percentage).</prim_outcome>
      <prim_outcome>Shoulder internal rotation range of motionMeasured by a Mobeemed electronic goniometer in seated position (90° shoulder abduction, 90° elbow flexion). Timepoint: at two time points:Pre-test: Three days before the start of the intervention (in two separate sessions with a 24‑hour interval to prevent fatigue)Post-test: Three days after the completion of the 6‑week intervention period. Method of measurement: Shoulder internal rotation range of motionMobeemed electronic goniometer in seated position with shoulder at ninety degrees abduction and elbow at ninety degrees flexion (degrees).</prim_outcome>
      <prim_outcome>Shoulder external rotation range of motionMeasured by a Mobeemed electronic goniometer in seated position (90° shoulder abduction, 90° elbow flexion) – degrees. Timepoint: at two time points:Pre-test: Three days before the start of the intervention (in two separate sessions with a 24‑hour interval to prevent fatigue)Post-test: Three days after the completion of the 6‑week intervention period. Method of measurement: Shoulder external rotation range of motionMobeemed electronic goniometer in seated position with shoulder at ninety degrees abduction and elbow at ninety degrees flexion (degrees).</prim_outcome>
      <prim_outcome>Shoulder internal rotation joint position senseMeasured by the active angle reproduction method at target angles of 30°, 45°, and 60° using a Mobeemed device – angular error in degrees. Timepoint: at two time points:Pre-test: Three days before the start of the intervention (in two separate sessions with a 24‑hour interval to prevent fatigue)Post-test: Three days after the completion of the 6‑week intervention period. Method of measurement: Shoulder internal rotation joint position senseMobeemed electronic goniometer using active angle reproduction method at target angles of thirty, forty‑five, and sixty degrees (angular error in degrees).</prim_outcome>
      <prim_outcome>Shoulder external rotation joint position senseMeasured by the active angle reproduction method at target angles of 30°, 45°, and 60° using a Mobeemed device – angular error in degrees. Timepoint: at two time points:Pre-test: Three days before the start of the intervention (in two separate sessions with a 24‑hour interval to prevent fatigue)Post-test: Three days after the completion of the 6‑week intervention period. Method of measurement: Shoulder external rotation joint position senseMobeemed electronic goniometer using active angle reproduction method at target angles of thirty, forty‑five, and sixty degrees (angular error in degrees).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-07-15</approval_date>
        <contact_name>Research Ethics Committee Of Shahid Beheshti University</contact_name>
        <contact_address>Shahid beheshti university, shahid shahriari, Evin, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
