Protocol summary

Study aim
Purpose of the present study is to the effect of neuromuscular exercises with dual cognitive tasks on balance, range of motion, performance and plantar pressure distribution in female athletes with a history of LAS.
Design
Clinical trial with two intervention groups, with parralell groups, single blinded , randomized
Settings and conduct
The tests will be conducted by the specialist at the sports science laboratory of Shiraz University in Shiraz, and then interventions and exercises will take place in the gym. during the testing, the participation will be unaware of the main purpose of the research.
Participants/Inclusion and exclusion criteria
Normal body mass index (BMI) between 20 and 25, At least 3 years of sports experience, Having a history of at least one sprain in the 12 months before starting the study, A previous injury caused recurrent sprain and a feeling of giving away and instability in the ankle joint, The last injury must have occurred at least three months before enrollment in the study, A score of 24 or less on the Cumberland Questionnaire.
Intervention groups
Neuromuscular exercises group with dual cognitive tasks, neuromuscular exercises group without dual cognitive tasks
Main outcome variables
Recurrent ankle sprains; Feeling of instability and giving away in the ankle joint

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240526061896N1
Registration date: 2024-06-15, 1403/03/26
Registration timing: registered_while_recruiting

Last update: 2024-06-15, 1403/03/26
Update count: 0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Fatemeh Talebi
Name of organization / entity
Bu-ali Sina University, Hamedan
Country
Iran (Islamic Republic of)
Phone
+98 991 757 3385
Email address
f.talebi@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-15, 1403/03/26
Expected recruitment end date
2024-07-18, 1403/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neuromuscular exercises with dual cognitive tasks on balance, range of motion, performance and plantar pressure distribution in female athletes with a history of LAS
Public title
The effect of neuromuscular exercises with dual cognitive tasks in female athletes with a history of LAS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal body mass index (BMI) between 20 and 25 At least 3 years of sports experience Having a history of at least one sprain in the 12 months before starting the study A previous injury caused recurrent sprain and a feeling of giving away and instability in the ankle joint The last injury must have occurred at least three months prior to enrollment in the study A score of 24 or less on the Cumberland Questionnaire
Exclusion criteria:
History of fracture and lower limb surgery Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function History of vestibular system disorders Having diseases such as diabetes
Age
From 15 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Random number generator software is randomized And they will be assigned to dual groups based on the allocation concealment using the SNOSE method. The randomization of subjects is done in two stages. First, each subject chooses a number between 1-36 using Random number generator software, then eighteen random numbers are selected between the numbers 1-36, and according to the generated numbers the chosen numbers of subjects are divided into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessors (laboratory technicians) are asked to take the intended 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 University
Street address
Bu Ali Sina University, Abu Taleb St, Modares Town
City
Hamedan
Province
Hamadan
Postal code
3869565178
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.BASU.REC.1402.079

Health conditions studied

1

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

Secondary outcomes

1

Description
Range of motion
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
weight bearing lunge test

2

Description
Core endurance
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
Mc Gill's Torso endurance test

3

Description
Performance
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
Figure of 8 hop test

4

Description
Plantar pressure distribution
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
Foot pressure scanner

Intervention groups

1

Description
Intervention group: Neuromuscular exercises with cognitive intervention will be for 6 weeks, 3 sessions each week, for 1 hour. Equipment such as resistance bands and balance boards will be used to perform exercises. The exercise protocol of the present study will be implemented along with dual cognitive tasks.
Category
Rehabilitation

2

Description
Intervention group: Neuromuscular exercises without cognitive intervention will be for 6 weeks, 3 sessions each week, for 1 hour. Equipment such as resistance bands and balance boards will be used to perform exercises. The exercise protocol of the present study will be implemented along without dual cognitive tasks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Sports and Youth of Shiraz city
Full name of responsible person
Seyyed Kamal Pak Fetrat
Street address
in front of Hafez tomb, Hafeziye crossroad, Shiraz
City
Shiraz
Province
Fars
Postal code
7145685355
Phone
+98 71 3731 3040
Email
f.talebi@phe.basu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Farzane saki
Street address
Bu Ali Sina University, Abu Taleb St, Modares town
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
Bu Ali Sina 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
Bu Ali Sina University
Full name of responsible person
Fatemeh Talebi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport rehabilitation
Street address
Hadith St., Shahid Aghaei St., Pasdaran Boulevard, shiraz twon
City
Shiraz
Province
Fars
Postal code
7185796463
Phone
+98 71 3822 8259
Email
f.talebi@phe.basu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Fatemeh Talebi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport rehabilitation
Street address
Hadith St., Shahid Aghaei St., Pasdaran Boulevard, shiraz twon
City
Shiraz
Province
Fars
Postal code
7185796463
Phone
+98 71 3822 8259
Email
f.talebi@phe.basu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Fatemeh Talebi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport rehabilitation
Street address
Hadith St., Shahid Aghaei St., Pasdaran Boulevard, shiraz twon
City
Shiraz
Province
Fars
Postal code
7185796463
Phone
+98 71 3822 8259
Email
f.talebi@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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