Protocol summary

Study aim
The purpose of the present study was to compare the effect of Core Stabilization Exercises and TRX on the performance, strength and balance of athletes with ankle sprain
Design
Clinical trials with control group, with parallel groups, randomized
Settings and conduct
The subjects of the training groups did exercises for 8 weeks and 3 sessions per week recording each protocol During the 8 weeks, the control group did not do any activity. Evaluation of variables was done 48 hours before and after. Functional status assessment was performed by functional tests. The mutation test was executed in a 5-foot-long, five-meter-long path, marked with two cones. Each subject performed the test twice and then the best record was recorded. In order to evaluate the dynamic balance, Y balance test and the Stack test was used to evaluate the static balance.
Participants/Inclusion and exclusion criteria
Entry requirements : ankle sprain which causes pain or lagging for more than one day feeling of weakness pain, or chronic instability that attributed to early sprain and the experience of wiping out 6 months before the start of the study. Exit criteria: ankle fracture and bilateral ankle sprain as well as a history of knee ACL injury
Intervention groups
Different groups of research included each group of 10 people Group 1: Stabilization Exercises Group 2: TRX training Group 3: combined exercises (central stability + TRX) Group 4: controls
Main outcome variables
Lateral mutation test , Y balance test, Stack TEST

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170510033909N4
Registration date: 2019-07-06, 1398/04/15
Registration timing: retrospective

Last update: 2019-07-06, 1398/04/15
Update count: 0
Registration date
2019-07-06, 1398/04/15
Registrant information
Name
فرزانه تقیان
Name of organization / entity
دانشگاه آزاد اسلامی.واحد اصفهان
Country
Iran (Islamic Republic of)
Phone
+98 913 308 0241
Email address
f.taghian@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
2018-08-06, 1397/05/15
Actual recruitment end date
2018-08-06, 1397/05/15
Trial completion date
2018-10-23, 1397/08/01
Scientific title
to compare the effect of trunk core stability training and TRX on the performance, balance and strength of athletes with ankle sprain
Public title
to compare the effect of trunk core stability training and TRX on the performance, balance and strength of athletes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria to enter the study A history of an ankle sprain that leads to pain or lagging for more than a day feeling of weakness pain, or chronic instability attributed to the early sprain the experience of wiping out 6 months before the start of the study
Exclusion criteria:
Exit criteria in this study were ankle fracture bilateral ankle sprain and also a history of knee ACL injury
Age
From 19 years old to 26 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on a single sequence of random assignments that is called simple randomization. The Roll of a die method is used for three group studies. The numbers 1 and 2 for the first group were numbers 3 and 4 for the second group and the numbers 5 and 6 for the third group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of khorasgan University
Street address
No.3 Baharan ave.Ostad shahriar jonobi st .Robat
City
isfahan
Province
Isfehan
Postal code
81838-95153
Approval date
2018-06-03, 1397/03/13
Ethics committee reference number
Ir.iau.khuisf.rec.1397.018

Health conditions studied

1

Description of health condition studied
Ankle sprain
ICD-10 code
S93
ICD-10 code description
Dislocation and sprain of joints and ligaments at ankle, foot and toe level

Primary outcomes

1

Description
Performance, Static Balance, Dynamic Balance
Timepoint
At the beginning of the study, eight weeks after the implementation of the sports protocols
Method of measurement
Function: Mutation test. Static mode: Stroke. Dynamic balance y

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Core Stabilization Exercises
Category
Rehabilitation

2

Description
Intervention Group 2: TRX exercises
Category
Rehabilitation

3

Description
Control group: Routine care
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Doctor Mohammad Saleki's Office
Full name of responsible person
Mohamad Saleki
Street address
Building Azhand , Hakim Nezami Ave,Daghighi St
City
Isfahan
Postal code
8111111141
Phone
Fax
Email
F_taghian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khorasgan branch ,Islamic Azad university
Full name of responsible person
Majid Toghyani
Street address
Khorasgan University ,Arghavanie St, Esfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2352
Email
Toghiani@Hotmail.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khorasgan branch ,Islamic Azad 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
The University of Khorasgan Isfahan
Full name of responsible person
Farzaneh Taghian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
NO3.Baharan Ave,Ostad Shahriar St, Robat St.
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2352
Email
F_taghian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Khorasgan Isfahan
Full name of responsible person
Farzaneh Taghian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University .Arghavanie St. Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3454 2315
Email
F_taghian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzaneh Taghian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
NO3.Baharan Ave,Ostad Shahriar St, Robat St.
City
Isfahan
Province
Isfehan
Postal code
81838-95153
Phone
+98 31 3454 2315
Email
F_taghian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more info
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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