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The effect of 8-week of neuromuscular training with and without cognitive dual-task on proprioception, balance, strength and functional performance of athletes with anterior cruciate ligament deficiency

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History
# Registration date Revision Id
2 2025-05-13, 1404/02/23 340885
1 2022-12-16, 1401/09/25 249207
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  • General information

    Not blinded
    Single blinded
    1
    empty
    Subject: Request for Correction of Randomized and Blinding Information Dear reviewer, With greetings and respect, I would like to inform you that I have mistakenly entered the blinding and randomization details and kindly request permission to correct them. Sincerely, Masoud barzegar
    empty
    موضوع: درخواست اصلاح اطلاعات تصادفی‌سازی و کورسازی بازبین گرامی، با سلام و احترام، به اطلاع شما می‌رسانم که اطلاعات کورسازی و تصادفی‌سازی را به اشتباه وارد کرده‌ام و خواهشمندم اجازه دهید آنها را اصلاح کنم. با احترام، مسعود برزگر
    The current research method is interventional and semi-experimental. The statistical population of this research will be made up of male soccer players aged 18 to 35 in Mazandaran province who have a history of anterior cruciate ligament injury and tear. The injury of these people will be diagnosed under the supervision of a sports medicine specialist through MRI images. 39 subjects were selected from among the studied population and will be placed in three groups of 13 people. Using G.power software and assuming α = 0.05, thirty-six subjects are required for the current research, who according to the criteria for exiting and entering the research are randomly divided into three groups (a control group, an exercise group neuromuscular, and a group of neuromuscular exercises with dual tasks) will be considered.
    Using permuted block randomization (6 blocks with a size of 7), three treatment arms will be independently allocated to participants in a 1:1:1 ratio (after initial screening). The random sequence list will be generated by computer (Pocock SJ. Clinical Trials: A Practical Approach. Wiley; 1983) and the website https://www.randomizer.org. This process will be overseen by a blinded assessor to ensure allocation concealment.
    روش تحقیق حاضر مداخله‌ای و از نوع نیمه تجربی است. جامعه آماری تحقیق حاضر را مردان فوتبالیست مرد 18 تا 35 سال استان مازندران که دارای سابقه آسیب و پارگی لیگامان صلیبی قدامی هستند شکل خواهند داد. آسیب این افراد تحت نظر متخصص پزشکی ورزشی از طریق تصاویر MRI تشخیص داده خواهند شد. از میان جامعه مورد مطالعه 39 آزمودنی انتخاب شدند که در سه گروه 13 نفره جای خواهند گرفت. با استفاده از نرم افزار G.power و با فرض α=0.05، سی و شش نفر آزمودنی برای پژوهش حاضر مورد نیاز می‌باشد که با توجه به معیارهای خروج و ورود به تحقیق به صورت تصادفی در سه گروه (یک گروه کنترل، یک گروه تمرینات عصبی عضلانی، و یک گروه تمرینات عصبی عضلانی با تکالیف دوگانه) در نظر گرفته خواهند شد.
    با استفاده از تصادفی سازی بلوک های جایگزین شده تصادفی (6 بلوک با اندازه 7)، سه ترکیب درمانی به طور مستقل با نسبت 1: 1: 1: (پس از ارزیابی اولیه) به شرکت کنندگان اختصاص داده می شود. لیست توالی تصادفی توسط کامپیوتر (Pocock SJ. Clinical Trials: A Practical Approach. Wiley; 1983) و همچنین وبسایت (https://www.randomizer.org) انجام می شود. این مرحله توسط یک ارزیاب کور تضمین خواهد شد.
    The outcome assessor will be blinded to group allocation. Participants will not be blinded to the study or their assigned group; however, they will be blinded to the specific intervention they receive (an unavoidable risk of bias exists in this study, as neither the intervention administrators nor the patients can be fully blinded to the treatment). Prior to assessments, the outcome assessor will receive standardized training on variable evaluation protocols to prevent any discussion or exchange of information between the assessor and participants during the trial.
    ارزیابی کننده پیامد ها نسبت به تخصیص گروهی کور خواهد بود. شرکت‌کنندگان نسبت به مطالعه و گروه بندی کور نخواهند بود، اما نسبت به مداخله ای که دریافت می کنند کور خواهند بود (خطر اجتناب‌ناپذیر سوگیری در این مطالعه وجود دارد که نمی‌توان مداخله را برای مداخله‌گران، بیماران کور کرد). پیش از ارزیابی آموزش های لازم به ارزیابی کننده پیامد ها در ارتباط با نحوه ارزیابی متغیر ها داده خواهد شد تا از هر گونه پرسش و پاسخ بین ارزیابی کننده و آزمودنی ها پیشگیری شود.

Protocol summary

Study aim
Investigating the effect of adding dual cognitive and motor tasks on the rehabilitation and preventive output of athletes who are transferred from a controlled rehabilitation environment to an uncontrolled playground environment
Design
The statistical population of the present study will be male football players aged 18 to 35 years in Mazandaran province who have a history of anterior cruciate ligament injury and rupture. Injury will be diagnosed under the supervision of a sports medicine specialist through MRI images. From the study population, 36 subjects will be selected who will be placed in three groups of 12 people.
Settings and conduct
The tests and exercises of the present study will be performed at the Academy of Sacrifice Health and Rehabilitation, and the Clinic of the Sports Medicine Board of Mazandaran Province.
Participants/Inclusion and exclusion criteria
Criteria for entering the research: 1. People with a history of grade 2 anterior cruciate ligament rupture in the past year 2. Soccer athletes 3. Having a BMI between 18 and 24 4. Not participating in lower limb rehabilitation programs in the last 6 months 5. Having a damaged knee joint up to 80 to 90% of the isokinetic strength of a healthy knee Exclusion variables: 1. History of complex and multi-ligament injuries of the knee joint 2. History of knee joint surgery 3. The presence of any abnormalities of the lower limbs and spine 4. Feeling of pain in the knee joint 5. Feeling of significant instability and relaxation in the knee joint 6. Sensory and neurological problems
Intervention groups
The first intervention group, neuromuscular exercises The second intervention group, neuromuscular exercises with dual tasks Matched control group, custom exercises
Main outcome variables
muscle strength; neuromuscular and sensorimotor coordination; balance; Specialized functional performance

General information

Reason for update
Subject: Request for Correction of Randomized and Blinding Information Dear reviewer, With greetings and respect, I would like to inform you that I have mistakenly entered the blinding and randomization details and kindly request permission to correct them. Sincerely, Masoud barzegar
Acronym
IRCT registration information
IRCT registration number: IRCT20220602055058N1
Registration date: 2022-12-16, 1401/09/25
Registration timing: retrospective

Last update: 2025-05-21, 1404/02/31
Update count: 1
Registration date
2022-12-16, 1401/09/25
Registrant information
Name
Masoud Barzegar
Name of organization / entity
The University of Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 11 3313 2601
Email address
msdbarzegar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8-week of neuromuscular training with and without cognitive dual-task on proprioception, balance, strength and functional performance of athletes with anterior cruciate ligament deficiency
Public title
The effect of neuromuscular training and cognitive tasks on functional performance of athletes with anterior cruciate ligament injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
lack of surgery, having 80-90% isokinetic strength of healthy opposite knee, lack of neurovascular problems and pain
Exclusion criteria:
Joint range of motion problems, pain, swelling, major meniscus rupture
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 39
Randomization (investigator's opinion)
Randomized
Randomization description
Using permuted block randomization (6 blocks with a size of 7), three treatment arms will be independently allocated to participants in a 1:1:1 ratio (after initial screening). The random sequence list will be generated by computer (Pocock SJ. Clinical Trials: A Practical Approach. Wiley; 1983) and the website https://www.randomizer.org. This process will be overseen by a blinded assessor to ensure allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor will be blinded to group allocation. Participants will not be blinded to the study or their assigned group; however, they will be blinded to the specific intervention they receive (an unavoidable risk of bias exists in this study, as neither the intervention administrators nor the patients can be fully blinded to the treatment). Prior to assessments, the outcome assessor will receive standardized training on variable evaluation protocols to prevent any discussion or exchange of information between the assessor and participants during the trial.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
پژوهشگاه تربیت بدنی و علوم ورزشی
Street address
Tehran - Ostad Motahhari St. - Mir Emad St. - Fifth Alley - No. 3
City
tehran
Province
Tehran
Postal code
1587958711
Approval date
2022-02-20, 1400/12/01
Ethics committee reference number
IR.SSRI.REC.1400.1340

Health conditions studied

1

Description of health condition studied
knee injury
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
1. Neuromuscular exercises with dual cognitive tasks2. Neuromuscular exercises without dual cognitive tasks1. Deep sense2. Equilibrium3. Power4. Performance
Timepoint
Winter 1400 to Summer 1401
Method of measurement
1. Consent form and personal information2. Digital scale for measuring weight3. Tape meter for measuring height4. Isokinetic device for measuring muscle strength5. Lower limb function test (LESS and Hopping tests)6. Goniometer to measure joint angle in depth sense test (position sense) in closed chain7. Digital camera to record video images in frontal and sagittal motion screens8. AutoCAD software for measuring detailed angle9. Quinoa software for outputting kinematic data10. Adhesive tape for dynamic balance test Y (Y)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First - neuromuscular exercises. Second - neuromuscular exercises with dual tasks. Third-control
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic
Full name of responsible person
Masoud Barzegar
Street address
Farhang
City
sari
Province
Mazandaran
Postal code
4849176751
Phone
+98 11 3330 5709
Email
msdbarzegar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Masoud Barzegar
Street address
khaghani
City
tehran
Province
Tehran
Postal code
4849176751
Phone
+98 935 287 5051
Email
msdbarzegar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
80
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
Iranian academic center for education culture and research
Full name of responsible person
Masoud Barzegar
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Farhang
City
sari
Province
Mazandaran
Postal code
4849176751
Phone
+98 935 287 5051
Email
msdbarzegar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Masoud Barzegar
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Farhang
City
sari
Province
Mazandaran
Postal code
4849176751
Phone
+98 935 287 5051
Email
msdbarzegar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Masoud Barzegar
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Farhang
City
sari
Province
Mazandaran
Postal code
4849176751
Phone
+98 935 287 5051
Email
msdbarzegar@gmail.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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Title and more details about the data/document
training
When the data will become available and for how long
one year
To whom data/document is available
barzegar
Under which criteria data/document could be used
progression
From where data/document is obtainable
ever
What processes are involved for a request to access data/document
total
Comments
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