Protocol summary

Study aim
To determine the effect of eight weeks of gluteal muscle strengthening exercises on performance and balance in adolescent basketball players with functional ankle instability.
Design
This study is a randomized controlled trial with a parallel‑group design conducted on 40 participants. Allocation will be performed using block randomization generated by the RAND function in Microsoft Excel. Outcome assessors and the data analyst will be blinded.
Settings and conduct
This randomized controlled trial will be conducted in Shiraz, Iran, at Mehrsam Basketball Club. Participants will be allocated by block randomization to exercise or control groups. The exercise group will perform an eight‑week gluteal strengthening program, while the control group continues regular training. The study is single‑blind, with outcome assessors and the data analyst blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 10–17 years; female active basketball players; history of ankle giving way in the past 6 months; IdFAI score >11; history of ankle sprain; no medical contraindication to exercise; informed consent obtained. Exclusion criteria: Acute lower‑limb injury, fracture, or surgery in the past 3 months; acute ankle pain or inflammation at baseline; neurological or systemic diseases affecting balance.
Intervention groups
Control group: Participants in the control group will continue their regular and routine basketball training without receiving any additional exercise intervention during the study period. Exercise group: Participants in the exercise group will perform a comprehensive gluteal muscle strengthening exercise program for eight weeks, in addition to their regular basketball training.
Main outcome variables
Dynamic balance; vertical jump; agility; 10‑m sprint speed with and without the ball; functional ankle instability.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180521039762N6
Registration date: 2026-02-07, 1404/11/18
Registration timing: prospective

Last update: 2026-02-07, 1404/11/18
Update count: 0
Registration date
2026-02-07, 1404/11/18
Registrant information
Name
Afshin Moghadasi
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3793 4208
Email address
afshin.moghadasi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-20, 1404/12/01
Expected recruitment end date
2026-03-13, 1404/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of gluteal muscle strengthening on performance and balance in adolescent basketball players with functional ankle instability
Public title
Effect of Gluteal Muscle Strengthening on Balance and Athletic Performance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 10 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Payame Noor University
Street address
Payame Noor University, Nakhl St., Artesh Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
193954697
Approval date
2025-07-15, 1404/04/24
Ethics committee reference number
IR.PNU.REC.1404.364

Health conditions studied

1

Description of health condition studied
Functional Ankle Instability
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle

Primary outcomes

1

Description
Dynamic balance
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Y Balance Test

2

Description
Explosive power of the lower limb muscles
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Vertical jump test

3

Description
Agility
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Illinois agility test

4

Description
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

Secondary outcomes

1

Description
Severity of functional ankle instability
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Identification of Functional Ankle Instability questionnaire

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
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.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehrsam Basketball Club
Full name of responsible person
Darya Farhadpour
Street address
Parvaresh Sports Club, Marefat St., Rahmat Blvd.
City
Shiraz
Province
Fars
Postal code
7396173751
Phone
+98 71 4221 3302
Email
mehrsam.basketball@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Payame Noor University
Full name of responsible person
ِDr. Majid Zamahni
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
193954697
Phone
+98 21 2332 0000
Email
zamahani@pnu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payame Noor University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Afshin Moghadasi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Injury and Corrective Exercises
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
193954697
Phone
+98 21 2332 0000
Email
moghadasi@pnu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Afshin Moghadasi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Injury and Corrective Exercises
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
193954697
Phone
+98 21 2332 0000
Email
moghadasi@pnu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Afshin Moghadasi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Injury and Corrective Exercises
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
193954697
Phone
+98 21 2332 0000
Email
moghadasi@pnu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
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 data/document is available
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.
Under which criteria data/document could be used
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.
From where data/document is obtainable
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.
What processes are involved for a request to access data/document
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.
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