History
# Registration date Revision Id
2 2023-06-27, 1402/04/06 269791
1 2023-06-26, 1402/04/05 269486
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  • Protocol summary

    The clinical trial has two groups of neuromuscular training with cognitive intervention and neuromuscular without cognitive intervention., with parallel groups, double-blinded, randomized, phase 2 on 44 participants. Randomization is done based on the Random Number Generator software, and they will be assigned to double groups based on the allocation concealment using the SNOSE method.
    The clinical trial has two groups of neuromuscular training with cognitive intervention and neuromuscular without cognitive intervention, with parallel groups, double-blinded, randomized, phase 2 on 44 participants. Randomization is done based on the Random Number Generator software, and they will be assigned to double groups based on the allocation concealment using the SNOSE method.
    Group of neuromuscular training with cognitive intervention: balance, strength, plyometric and crunch exercises with cognitive exercises to check the amount of attention needs of pastural control for 8 weeks and three 1-hour sessions every week. Group of neuromuscular training without cognitive intervention: balance, strength, plyometric and agility exercises for 8 weeks and three 1-hour sessions every week.
    Group of neuromuscular training with cognitive intervention: balance, strength, plyometric and agility exercises with cognitive exercises to examine the amount of attention needs of pastural control for 8 weeks and three 1-hour sessions every week. Group of neuromuscular training without cognitive intervention: balance, strength, plyometric and agility exercises for 8 weeks and three 1-hour sessions every week.
  • General information

    empty
    Editing the original English name of the device that will be used in the laboratory to measure the primary outcome variable of displacement of the center of pressure, adding items related to how to measure the secondary outcome variable of chronic ankle instability, editing the English related to the intervention groups in the protocol abstract.
    empty
    ویرایش نام انگلیسی اصلی دستگاهی که در آزمایشگاه برای اندازه گیری متغیر پیامد اولیه جابه جایی مرکز فشار استفاده خواهد شد، اضافه کردن موارد مربوط به نحوه اندازه گیری متغیر پیامد ثانویه بی ثباتی مزمن مچ پا، ویرایش انگلیسی مربوط به گروه های مداخله در قسمت چکیده پروتکل
  • Primary outcomes

    #1
    Y test, foot lift test
    Y balance test, Foot lift test
    تست وای، تست بلند کردن پا
    تست تعادل وای، تست بلند کردن پا
    #2
    Foot scan
    RS-Scan device
  • Secondary outcomes

    #1
    Electrogoniometer, Dynamometer
    Electrogoniometer, Dynamometer, RS-Scan device, Y balance test, Foot lift test
    الکتروگونیامتر، دینامومتر
    الکتروگونیامتر، دینامومتر، اسکنر فشار کف پا، تست تعادل وای، تست بلند کردن پا
  • Intervention groups

    #1
    The neuromuscular training with cognitive intervention, exercises for 8 weeks and three 1-hour sessions each week. Neuromuscular training will include balance, strength, plyometric and agility exercises. Cognitive exercises will be used as an effective strategy for this group to examine the amount of attention needs of pastural control.
    The neuromuscular training with cognitive intervention, exercises for 8 weeks and three 1-hour sessions each week. Neuromuscular training will include balance, strength, plyometric and agility exercises. Cognitive exercises will be used as an effective strategy for this group to examine the amount of attention needs of pastural control.

Protocol summary

Study aim
Determining the effect of neuromuscular training with and without cognitive intervention on balance, strength, proprioception and center of pressure displacement in active females at risk of ankle sprain
Design
The clinical trial has two groups of neuromuscular training with cognitive intervention and neuromuscular without cognitive intervention, with parallel groups, double-blinded, randomized, phase 2 on 44 participants. Randomization is done based on the Random Number Generator software, and they will be assigned to double groups based on the allocation concealment using the SNOSE method.
Settings and conduct
This study will be performed in a double-blinded manner. The tests will be taken in the sport rehabilitation laboratory of Bu Ali Sina University in Hamedan by specialists, then intervention and exersices will take place in the university gym.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: active females at risk of ankle sprain with a normal body mass index of 20-25, age range of 16-30 years, dynamic balance score and a score of 13-15 from the Beck questionnaire and exclusion criteria: a history of ankle sprain injury, fracture, injury or surgery of the lower limb, abnormalities of the lower limb such as: foot flat, genu varum, genu valgum, genu recurvatom, history of vestibular system disorders, the presence of diseases such as diabetes
Intervention groups
Group of neuromuscular training with cognitive intervention: balance, strength, plyometric and agility exercises with cognitive exercises to examine the amount of attention needs of pastural control for 8 weeks and three 1-hour sessions every week. Group of neuromuscular training without cognitive intervention: balance, strength, plyometric and agility exercises for 8 weeks and three 1-hour sessions every week.
Main outcome variables
Balance, Strength, Proprioception, Center of pressure displacement

General information

Reason for update
Editing the original English name of the device that will be used in the laboratory to measure the primary outcome variable of displacement of the center of pressure, adding items related to how to measure the secondary outcome variable of chronic ankle instability, editing the English related to the intervention groups in the protocol abstract.
Acronym
IRCT registration information
IRCT registration number: IRCT20230619058535N1
Registration date: 2023-06-26, 1402/04/05
Registration timing: prospective

Last update: 2023-06-28, 1402/04/07
Update count: 1
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
Mina Mansouri
Name of organization / entity
Bu-Ali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 31 5223 0032
Email address
m.mansouribidekani@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-25, 1402/06/03
Expected recruitment end date
2023-09-04, 1402/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neuromuscular training with and without cognitive intervention on proprioception‚ balance‚ strength and center of pressure displacement in active females at risk of ankle sprain
Public title
The effect of neuromuscular training with and without cognitive intervention on ankle sprain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Normal body mass index is 20-25 Age range 16-30 years Obtaining a dynamic balance score Obtaining a score of 13-15 from Beck's questionnaire
Exclusion criteria:
History of ankle sprain injury History of fracture, injury or surgery of the lower limb Abnormalities of the lower limbs include Foot Flat, Genu Varum, Genu Valgum, Genu Recurvatom History of Vestibular System disorders The presence of diseases such as diabetes
Age
From 16 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done based on the Random Number Generator software, and they will be assigned to double groups based on the allocation concealment using the SNOSE method. The randomization of subjects is done in two steps. First, each subject chooses a number between 1-30 using a lottery, then fifteen random numbers are selected between 1-30 numbers using the Random Number Generator software and according to the generated numbers and the selected numbers, subjects are divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, outcome assessors (laboratory technicians) are asked to take the desired tests from the clients. These people will be unaware of the purpose of the research, the allocation of study groups and the reason for their presence in the laboratory, and they will only evaluate the variables and record their observations.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Bu Ali Sina Hamadan University
Street address
Bu Ali Sina University, Abu Taleb ST, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.BASU.REC.1402.022

Health conditions studied

1

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

Primary outcomes

1

Description
Balance
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
Y balance test, Foot lift test

2

Description
Strength
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
Dynamometer

3

Description
Proprioception
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
Electrogoniometer

4

Description
Center of pressure displacement
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
RS-Scan device

Secondary outcomes

1

Description
Chronic ankle instability (CAI)
Timepoint
Before and after the intervention
Method of measurement
Electrogoniometer, Dynamometer, RS-Scan device, Y balance test, Foot lift test

Intervention groups

1

Description
The neuromuscular training with cognitive intervention, exercises for 8 weeks and three 1-hour sessions each week. Neuromuscular training will include balance, strength, plyometric and agility exercises. Cognitive exercises will be used as an effective strategy for this group to examine the amount of attention needs of pastural control.
Category
Prevention

2

Description
Intervention group: the neuromuscular training without cognitive intervention, exercises for 8 weeks and three 1-hour sessions each we ek. Neuromuscular training will include balance, strength, plyometric and agility exercises.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamedan basketball board
Full name of responsible person
Mina Mansouri
Street address
Bu Ali siSina Univerty, Abu Taleb ST, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
m.mansouribidekani@phe.basu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Bu Ali Sina
Full name of responsible person
Farzaneh Saki
Street address
Bu Ali Sina University, Abu Taleb ST, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
f.sport2008@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Bu Ali Sina
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
The University of Bu Ali Sina
Full name of responsible person
Mina Mansouri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport rehabilitation
Street address
Bu Ali Sina University, Abu Taleb ST, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
m.mansouribidekani@phe.basu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Bu Ali Sina
Full name of responsible person
Mina Mansouri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport rehabilitation
Street address
Bu Ali Sina University, Abu Taleb ST, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
m.mansouribidekani@ph.basu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Bu Ali Sina
Full name of responsible person
Mina Mansouri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport rehabilitation
Street address
Bu Ali Sina University, Abu Taleb ST, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
m.mansouribidekani@phe.basu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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