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IRCT20251221068402N1 IRCT 2026-02-06 Vice President for Research, Bu-Ali Sina University, Hamadan The effect of combined exercises on the electrical brain activity of athletes with chronic ankle instability. Effects of combined and dual-task training on brain electrical activity, proprioception and balance in athletes with chronic ankle instability: A randomized controlled clinical trial 2026-01-26 anticipated 66 Complete https://irct.ir/trial/88261 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After confirming eligibility criteria and obtaining written informed consent, participants will be randomly allocated in a 1:1:1 ratio to one of the three study groups. The randomization sequence will be generated by an independent individual who is not involved in participant recruitment, assessment, intervention, or data analysis, using Random Allocation Software (RAS) and a variable block randomization method with block sizes of 3 and 6 to prevent predictability of the allocation sequence. Allocation codes for each participant will be placed sequentially into opaque, light-proof, sealed, and consecutively numbered envelopes (SNOSE). After a participant is definitively enrolled in the study, the corresponding envelope will be opened in sequence and the assigned group will be revealed. Accordingly, group assignment will remain concealed from researchers and outcome assessors until the moment of allocation, thereby minimizing selection bias, Blinding description: The evaluation of the participants will be performed by a physiotherapist who is blinded to group allocation. N/A chronic ankle instability. Intervention 1: Intervention group 1:Participants in intervention group 1 will receive a combined training program consisting of neuromuscular and cognitive exercises performed separately. The program will be implemented over 8 weeks, with three sessions per week, each lasting 60 minutes (24 sessions in total).Each session will comprise two main components. The neuromuscular component, designed to improve postural control, balance, coordination, and strengthening of the lower-limb muscles—particularly the ankle, will include balance exercises such as single-leg stance on a stable surface, single-leg stance on a balance board, toe walking, and the runner’s knee exercise. All balance exercises will be performed under both eyes-open and eyes-closed conditions to increase sensorimotor challenge. In addition, ankle strengthening exercises will be incorporated to enhance muscular strength and motor control.The cognitive component will consist of mental and cognitive tasks performed separately from the neuromuscular rehabilitation program, such as backward counting of four-digit numbers, aimed at engaging attention, working memory, and cognitive processing. To comply with the principle of progressive overload, the intensity and/or complexity of the exercises will be increased progressively, with progression applied during weeks 2, 4, and 6. Intervention 2: Intervention group 2 received a dual task/task training program in which neuromuscular exercises and cognitive exercises were performed simultaneously to increase cognitive load and simultaneously engage the neuromuscular and musculoskeletal systems. This intervention was conducted for 8 weeks, with sessions held 3 times a week for 30 minutes each (24 sessions in total). The content of neuromuscular exercises mainly included balance exercises performed in the form of single-leg standing, tiptoe walking, and static and dynamic balance exercises. To increase the sensorimotor challenge, these exercises were performed in both eyes open and eyes closed modes. Simultaneously with the balance exercises, the cognitive task was performed in the form of counting back four digits to increase cognitive load during motor activity. During the course, the difficulty of the exercises was gradually adjusted by changing the visual conditions (eyes open/closed), increasing the duration of maintaining balance positions, or increasing the complexity of the cognitive task. To perform the exercises, a safe training space was used, and if necessary, simple balance tools such as a balance board were used, and all sessions were carried out according to a specific program and in compliance with safety principles. Intervention 3: Control group: Athletes went about their daily activities and did not do any rehabilitation. Yes - There is a plan to make this available What will be shared: The files containing data measured by the assessors will be shared, if needed, after the completion of the study. When: The sharing period will begin one year following the publication of the study results and related articles. To whom: Researchers and researchers whose field of work is similar to the present research and are employed in universities Conditions: The data of the present study will be provided to other researchers only for comparison with future studies and the use of data and their analysis is not allowed. Where to obtain: Email adress m.azizian@phe.basu.ac.ir Phone number: 00989188157747 How to obtain: A full description of the research should be provided and the details of the use of the data should be fully described. Comments:
public Ali Yalfani
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan
Hamedan Iran (Islamic Republic of) ۳۸۶۹۵-۶۵۱۷۸ 0098 81 8265636 Aliyalfani@yahoo.com Bu-Ali sina University scientific Ali Yalfani
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan
Hamedan Iran (Islamic Republic of) ۳۸۶۹۵-۶۵۱۷۸ 0098 81 8265636 Aliyalfani@yahoo.com Bu Ali Sina University of Hamadan Iran (Islamic Republic of) No history of knee ligament or meniscus injury, which will be verified by subjects completing a medical history form No history of fractures or surgery on lower limb joints. No history of neurological or vestibular system disorders. History of at least one ankle sprain in the past 12 months prior to study entry that resulted in a cessation of physical activity for at least one day The person has had the feeling of emptying at least twice in the past 6 months. Score less than 24 on the Cumberland Ankle Instability Questionnaire. 18 years 25 years Both People with anterior cruciate ligament tears. Athletes with chronic ankle instability who are under 18 and over 25 years of age. Positive anterior ankle abduction test. M25.373 Other instability, unspecified ankle Rehabilitation Rehabilitation N/A Intervention group 1:Participants in intervention group 1 will receive a combined training program consisting of neuromuscular and cognitive exercises performed separately. The program will be implemented over 8 weeks, with three sessions per week, each lasting 60 minutes (24 sessions in total).Each session will comprise two main components. The neuromuscular component, designed to improve postural control, balance, coordination, and strengthening of the lower-limb muscles—particularly the ankle, will include balance exercises such as single-leg stance on a stable surface, single-leg stance on a balance board, toe walking, and the runner’s knee exercise. All balance exercises will be performed under both eyes-open and eyes-closed conditions to increase sensorimotor challenge. In addition, ankle strengthening exercises will be incorporated to enhance muscular strength and motor control.The cognitive component will consist of mental and cognitive tasks performed separately from the neuromuscular rehabilitation program, such as backward counting of four-digit numbers, aimed at engaging attention, working memory, and cognitive processing. To comply with the principle of progressive overload, the intensity and/or complexity of the exercises will be increased progressively, with progression applied during weeks 2, 4, and 6. Intervention group 2 received a dual task/task training program in which neuromuscular exercises and cognitive exercises were performed simultaneously to increase cognitive load and simultaneously engage the neuromuscular and musculoskeletal systems. This intervention was conducted for 8 weeks, with sessions held 3 times a week for 30 minutes each (24 sessions in total). The content of neuromuscular exercises mainly included balance exercises performed in the form of single-leg standing, tiptoe walking, and static and dynamic balance exercises. To increase the sensorimotor challenge, these exercises were performed in both eyes open and eyes closed modes. Simultaneously with the balance exercises, the cognitive task was performed in the form of counting back four digits to increase cognitive load during motor activity. During the course, the difficulty of the exercises was gradually adjusted by changing the visual conditions (eyes open/closed), increasing the duration of maintaining balance positions, or increasing the complexity of the cognitive task. To perform the exercises, a safe training space was used, and if necessary, simple balance tools such as a balance board were used, and all sessions were carried out according to a specific program and in compliance with safety principles. Control group: Athletes went about their daily activities and did not do any rehabilitation. Brain electrical activity. Timepoint: Before and after the 8-week intervention. Method of measurement: Using the Medina Teb Electroencephalography device, the electrical activity of the brain is measured in a state of single-leg balance. Quality of life. Timepoint: Before and after the 8-week intervention. Method of measurement: The Short Form Health Survey (SF-36). Static balance. Timepoint: Before and after the 8-week intervention. Method of measurement: Using a single-leg Zabris foot pressure device manufactured in the United States. Functional disability. Timepoint: Before and after the 8-week intervention. Method of measurement: Oswestry Questionnaire. Proprioception. Timepoint: Before and after the 8-week intervention. Method of measurement: Electrogoniametr. Vice President for Research, Bu-Ali Sina University, Hamadan Approved 2025-10-05 Bu Ali Sina University Ethics Committee Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan hamedan Hamadan Iran (Islamic Republic of)