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IRCT20180521039762N6 IRCT 2026-02-07 Payame Noor University Effect of Gluteal Muscle Strengthening on Balance and Athletic Performance The effect of gluteal muscle strengthening on performance and balance in adolescent basketball players with functional ankle instability 2026-02-20 anticipated 40 Complete https://irct.ir/trial/88966 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible participants will be randomly allocated to the study groups after baseline assessment and before the start of the intervention. Block randomization with an individual unit of randomization will be used to ensure balanced allocation between groups. The random allocation sequence will be generated using the RAND function in Microsoft Excel. Allocation concealment will be ensured by using sequentially numbered, opaque, sealed envelopes, which will be opened only after the final enrollment of each participant, Blinding description: Due to the nature of the exercise intervention, blinding of participants and intervention providers will not be feasible, as participants must be informed about the general study objectives and training procedures. However, participants will not be informed about the type of intervention received by the other group. To minimize bias, outcome assessors and the statistical data analyst will be blinded to group allocation and will not be involved in the randomization or intervention procedures. Blinding will therefore be applied at the level of outcome assessment and data analysis. N/A Functional Ankle Instability. Intervention 1: Intervention group: Participants in this group will receive a comprehensive gluteal muscle strengthening exercise program for eight weeks. The program will be performed three sessions per week, with each session lasting approximately 30 to 45 minutes in the initial weeks, progressively increasing to 60 to 75 minutes in the final weeks.The training program will include a combination of the following components: 1. Gluteal strengthening exercises under non-weight-bearing conditions 2. Strengthening exercises targeting local and global stabilizing muscles of the pelvis and lower extremity 3. Isolated activation and strengthening exercises for the gluteal muscles 4. Weight-bearing strengthening exercises integrated into fundamental movement patterns 5. Reactive neuromuscular training exercises aimed at improving motor control and functional stability of the lower extremity. The exercise program will be conducted in addition to regular basketball training and will be supervised by the researcher. Intervention 2: Control group: Participants in this group will continue their regular basketball training program throughout the study period and will not receive any specific gluteal muscle strengthening exercises or additional rehabilitation interventions. Yes - There is a plan to make this available What will be shared: Title: De-identified individual participant data, study protocol, statistical analysis plan, clinical study report, and data dictionary Details: De-identified individual participant data (IPD), the study protocol, statistical analysis plan, clinical study report, and data dictionary will be available upon completion of the study and main publication. Access is granted to qualified researchers via a formal request and is subject to approval and commitment to confidentiality. When: Access to the documents and de-identified data will commence immediately following the final completion of the study and publication of the main results (primary manuscript). This access will be maintained for a period of at least 5 years from the publication date. To whom: The data will be accessible to all academic and non-academic researchers from scientific and medical institutions. Requests must be submitted by a formal Principal Investigator (PI). The main condition for access is the submission of a scientifically sound analysis plan, signing of a Data Use Agreement (DUA), and a commitment to maintaining participant confidentiality and using the data strictly for research purposes. Conditions: Purpose of Use: The primary purpose of data sharing is to enable complementary scientific analyses, replication of primary findings, and re-analysis of the data by independent researchers. Mandatory Conditions: 1. Valid Research Plan: The applicant must submit a scientifically sound research proposal or protocol detailing the intended use of the requested data. 2. Non-Commercial and Research Use: Use of the data and documents must be strictly for research and educational purposes. Any commercial or proprietary use is prohibited. 3. Agreement Signing: The applicant must sign a Data Use Agreement (DUA), committing to the complete confidentiality of participants and explicitly agreeing not to attempt re-identification. 4. Attribution (Citation): If any results are published, the researcher receiving the data must cite the original study (IRCT) and the primary publication. Where to obtain: Applicants must submit a formal request containing a detailed scientific analysis plan, along with their full contact information, to the email address of Dr. Afshin Moghadasi (moghadasi@pnu.ac.ir). Following the review and approval of the proposal by the research team, and upon meeting the required criteria, a Data Use Agreement (DUA) will be issued for signature. Subsequently, the de-identified data will be shared with the applicant. How to obtain: The process for accessing the data and documentation of the “Effect of Gluteal Muscle Strengthening on Balance and Athletic Performance” study involves four main stages: 1. Formal Application: The applicant must submit a formal request including a detailed scientific analysis plan, full contact details, and a commitment to research-only use, to the email address of the primary contact (Dr. Afshin Moghadasi: moghadasi@pnu.ac.ir). 2. Proposal Review (Estimated Time: 1 to 3 working weeks): The applicant’s request will be reviewed by the study’s research team for scientific merit, alignment with the primary publication objective, and adherence to ethical standards. 3. DUA Execution (Estimated Time: 2 to 4 working weeks): If the proposal is approved, a Data Use Agreement (DUA) will be sent to the applicant. The applicant is required to sign this document and return it to the research team. This agreement mandates a commitment to maintaining confidentiality and not attempting to re-identify participants. 4. Data Provision (Estimated Time: 1 to 3 working days): Upon receipt of the fully executed DUA and finalization of administrative procedures, the de-identified data and approved documentation (protocol, analysis plan, etc.) will be provided to the applicant in electronic files. Overall Time Estimation: The estimated time to complete the entire process, from receiving the initial request to the final provision of data, assuming the applicant provides complete documentation and the proposal is quickly approved, is approximately 3 to 7 working weeks. Comments:
public Afshin Moghadasi
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
Tehran Iran (Islamic Republic of) 193954697 +98 21 2332 0000 moghadasi@pnu.ac.ir Payame Noor University scientific Afshin Moghadasi
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
Tehran Iran (Islamic Republic of) 193954697 +98 21 2332 0000 moghadasi@pnu.ac.ir Payame Noor University Iran (Islamic Republic of) Age between 10 and 17 years Female active basketball players Subjective feeling of ankle giving way during the past six months IdFAI score greater than 11 History of ankle sprain No medical contraindication for participation in physical activity and completion of written informed consent 10 years 17 years Female Presence of acute musculoskeletal injury, fracture, or surgery in the lower limbs Presence of pain, inflammation, or signs of acute ankle injury at baseline Presence of neurological or systemic diseases affecting balance or motor performance S93.4 Sprain of ankle Rehabilitation N/A Intervention group: Participants in this group will receive a comprehensive gluteal muscle strengthening exercise program for eight weeks. The program will be performed three sessions per week, with each session lasting approximately 30 to 45 minutes in the initial weeks, progressively increasing to 60 to 75 minutes in the final weeks.The training program will include a combination of the following components: 1. Gluteal strengthening exercises under non-weight-bearing conditions 2. Strengthening exercises targeting local and global stabilizing muscles of the pelvis and lower extremity 3. Isolated activation and strengthening exercises for the gluteal muscles 4. Weight-bearing strengthening exercises integrated into fundamental movement patterns 5. Reactive neuromuscular training exercises aimed at improving motor control and functional stability of the lower extremity. The exercise program will be conducted in addition to regular basketball training and will be supervised by the researcher. Control group: Participants in this group will continue their regular basketball training program throughout the study period and will not receive any specific gluteal muscle strengthening exercises or additional rehabilitation interventions. Dynamic balance. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Y Balance Test. Explosive power of the lower limb muscles. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Vertical jump test. Agility. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Illinois agility test. Running speed over a ten‑meter distance with and without the ball. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Ten‑meter sprint test with and without the ball. Severity of functional ankle instability. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Identification of Functional Ankle Instability questionnaire. Payame Noor University Approved 2025-07-15 Research Ethics Committees of Payame Noor University Payame Noor University, Nakhl St., Artesh Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)