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
Comparison of the effectiveness of combined and dual-task exercises on brain electrical activity, proprioception, and balance in athletes with chronic ankle instability.
Design
The present study is a randomized controlled clinical trial that includes a statistical population of male and women athletes (18-25 years old) with chronic ankle instability.
Settings and conduct
Men and women with chronic ankle instability who refer to orthopedic and physiotherapy clinics in Hamadan will be recruited. Eligible participants will be enrolled in the study and randomly allocated to the intervention and control groups using block randomization. This study will be conducted as a single-blind trial, in which the assessor will be blinded to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Athletes with chronic ankle instability, Cumberland Ankle Instability Tool (CAIT) score ≤ 24.
Exclusion criteria prior to randomization: History of anterior cruciate ligament (ACL) injury
Intervention groups
Intervention group 1: Participants will undergo separate neuromuscular and cognitive training for 8 weeks, 3 sessions per week, 60 minutes per session. Neuromuscular training includes balance exercises (eyes open/closed), balance board exercises, and high-knee walking, while cognitive training consists of isolated mental tasks (e.g., reversing four-digit numbers).
Intervention group 2:
Participants will undergo dual-task training for 8 weeks, 3 sessions per week, using the same neuromuscular exercises performed simultaneously with cognitive tasks, such as backward counting during balance exercises.
Control group:
The control group will receive no rehabilitation intervention during the 8-week period.
Main outcome variables
Electrical activity of the brain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251221068402N1
Registration date:2026-02-06, 1404/11/17
Registration timing:registered_while_recruiting
Last update:2026-02-06, 1404/11/17
Update count:0
Registration date
2026-02-06, 1404/11/17
Registrant information
Name
Masoud Azizian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 815 7747
Email address
masoudazizian72@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-26, 1404/11/06
Expected recruitment end date
2026-03-03, 1404/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of combined exercises on the electrical brain activity of athletes with chronic ankle instability.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
The evaluation of the participants will be performed by a physiotherapist who is blinded to group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bu Ali Sina University Ethics Committee
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan
City
hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Approval date
2025-10-05, 1404/07/13
Ethics committee reference number
IR.BASU.REC.1404.032
Health conditions studied
1
Description of health condition studied
chronic ankle instability
ICD-10 code
M25.373
ICD-10 code description
Other instability, unspecified ankle
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
Quality of life
Timepoint
Before and after the 8-week intervention
Method of measurement
The Short Form Health Survey (SF-36)
2
Description
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.
3
Description
Functional disability
Timepoint
Before and after the 8-week intervention
Method of measurement
Oswestry Questionnaire
4
Description
proprioception
Timepoint
Before and after the 8-week intervention
Method of measurement
Electrogoniametr
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
3
Description
Control group: Athletes went about their daily activities and did not do any rehabilitation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Sina University
Full name of responsible person
Ali Yalfani
Street address
Bu Ali Sina University, Shahid Mostafa Ahmadi Roshan Street
City
hamedan
Province
Hamadan
Postal code
۳۸۶۹۵,۶۵۱۷۸
Phone
+98 81 3838 1601
Fax
+98 81 3838 1601
Email
masoudazizian72@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President for Research, Bu-Ali Sina University, Hamadan
Full name of responsible person
Arash Gorbani
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
+98 81 3826 5636
Fax
Email
arashghorbani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President for Research, Bu-Ali Sina University, Hamadan
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
Bu-Ali sina University
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
0098 81 8265636
Fax
+98 21 3838 1601
Email
Aliyalfani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali Sina University of Hamadan
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
0098 81 8265636
Fax
+98 81 3838 1422
Email
Aliyalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bu Ali Sina University of Hamadan
Full name of responsible person
Masoud Azizian
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
0098 81 8265636
Email
masoudazizian72@yahoo.com
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The files containing data measured by the assessors will be shared, if needed, after the completion of the study.
When the data will become available and for how long
The sharing period will begin one year following the publication of the study results and related articles.
To whom data/document is available
Researchers and researchers whose field of work is similar to the present research and are employed in universities
Under which criteria data/document could be used
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.