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The comparison between ankle joint Kinesio tape and lower leg muscle Kinesio tape, on balance and proprioception in the subjects with recurrent lateral ankle sprain

Protocol summary

Study aim
The comparison between ankle joint Kinesio tape and lower leg muscle Kinesio tape, on balance and proprioception in the subjects with recurrent lateral ankle sprain
Design
Randomized (random block method), without placebo control, single arm trial. The sample size of this study is 42 individuals: divided into 3 groups of 12 people.
Settings and conduct
Banding to methods (Kinesio Tape) In the ankle joint and muscles around the ankle. Neuromuscular Rehabilitation Research Center Semnan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
42 athletes with ankle sprain. Inclusion criteria: Adults that have aged 18 to 40 years; individuals should experience frequent torsion and with giving way; People should not have ankle joint mechanical torsion. Exclusion criteria: Torsion at non-dominant foot; history of lower limb injury and neurological and musculoskeletal disorders; visual disturbances; history of lower limb surgery in the past year.
Intervention groups
Control group: Only for comparison with intervention group, no treatment is performed. Intervention group 1 (Taping on ankle muscles): At the first session, initial evaluations (according to the protocol) will be repeated 3 times during the session, then the same evaluations will be performed in 72 hours later to check the repeatability between the two sessions, and then, in the next step, the effect of the taping, including the main variables will be examined. Strips remain for 72 hours. The taping will be loaded 3 times in 10 days and the balance criteria will be evaluated. Intervention group 2 (Taping on ankle joint): At the first session, initial evaluations (according to the protocol) will be repeated 3 times during the session, then the same evaluations will be performed in 72 hours later to check the repeatability between the two sessions, and then, in the next step, the effect of the taping, including the main variables will be examined. Strips remain for 72 hours. The taping will be loaded 3 times in 10 days and the balance criteria will be evaluated.
Main outcome variables
Dynamic balance measurement, .

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151228025732N31
Registration date: 2018-03-16, 1396/12/25
Registration timing: registered_while_recruiting

Last update: 2018-03-16, 1396/12/25
Update count: 0
Registration date
2018-03-16, 1396/12/25
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-12, 1396/09/21
Expected recruitment end date
2018-09-11, 1397/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between ankle joint Kinesio tape and lower leg muscle Kinesio tape, on balance and proprioception in the subjects with recurrent lateral ankle sprain
Public title
The comparison between ankle joint Kinesio tape and lower leg muscle Kinesio tape in the subjects with recurrent lateral ankle sprain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adults that have aged 18 to 40 years Individuals should experience frequent torsion and with giving way People should not have mechanical torsion
Exclusion criteria:
Torsion at non-dominant foot History of lower limb injury and neurological and musculoskeletal disorders Visual disturbances History of lower limb surgery in the past year
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual. Randomized permutation blocks. Random sequence was generated using Excel software.
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.Semums.rec.1396.163

Health conditions studied

1

Description of health condition studied
Frequent torsion Ankle
ICD-10 code
S93.0
ICD-10 code description
Subluxation and dislocation of ankle joint

Primary outcomes

1

Description
Dynamic balance measurement
Timepoint
Before and after the intervention
Method of measurement
Biodex balance System

2

Description
Assessment deep feelings Joint ankle
Timepoint
Before and after the intervention
Method of measurement
Biodex System IV Isometric Dynameter

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Only for comparison with intervention group, no treatment is performed.
Category
Diagnosis

2

Description
Intervention group 1 (Taping on ankle muscles): At the first session, initial evaluations (according to the protocol) will be repeated 3 times during the session, then the same evaluations will be performed in 72 hours later to check the repeatability between the two sessions, and then, in the next step, the effect of the taping, including the main variables will be examined. Strips remain for 72 hours. The taping will be loaded 3 times in 10 days and the balance criteria will be evaluated.
Category
Rehabilitation

3

Description
Intervention group 2 (Taping on ankle joint): At the first session, initial evaluations (according to the protocol) will be repeated 3 times during the session, then the same evaluations will be performed in 72 hours later to check the repeatability between the two sessions, and then, in the next step, the effect of the taping, including the main variables will be examined. Strips remain for 72 hours. The taping will be loaded 3 times in 10 days and the balance criteria will be evaluated.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Ziaeddin Safavi-Farokhi
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi-Farokhi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi-Farokhi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Yazdan Yousefi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Ziaeddin Safavi-Farokhi. Neuromuscular Rehabilitation Research Center, Ghods Blvd. 00989123311988
What processes are involved for a request to access data/document
-
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