Protocol summary

Study aim
Comparing the immediate effect of distal versus proximal-distal kinsiotape on muscle strength, functional performance and gait initition profiles in athletes with and without functional ankle instability
Design
In this study, 15 healthy athletes and 15 athletes with functional ankle instability will be chosen purposefully according to the inclusion criteria.
Settings and conduct
This study will be performed in Biomechanics laboratory of Tehran University of Medical sciences.
Participants/Inclusion and exclusion criteria
Inclusion and Exclusion criteria in this study will be according to the position statement of the International Ankle Consortium for selection criteria for patients with chronic ankle instability in controlled research.Athletes aged 18 to 32 with a history of ankle sprain, at least six months to one year old, with no history of fracture or other musculoskeletal injuries, will participate in this study.
Intervention groups
Interventions in each groups(healthy athletes and athletes with functional ankle instability) are as follows: Distal Kinsio Taping Intervention: kinsio tape is applied on peroneus longus muscle to facilitate it. Proximal- distal kinsio taping intervention: in this intervention, in addition to facilitation technique for Peroneus Longus, facilitating kinsio tape for gluteus medius is used too.
Main outcome variables
Strength of hip abductors and ankle evertors; Functional performance tests; Temporal and spatial parameters of center of pressure(anticipatory, weight transfer and locomotive phase) in gait initiation

General information

Reason for update
Acronym
Comparing the two method of taping on muscle strenght and gait profiles in athletes
IRCT registration information
IRCT registration number: IRCT20171028037057N1
Registration date: 2018-01-17, 1396/10/27
Registration timing: registered_while_recruiting

Last update: 2018-01-17, 1396/10/27
Update count: 0
Registration date
2018-01-17, 1396/10/27
Registrant information
Name
Sara Fereydounnia
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 8468
Email address
s-fereydounnia@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the immediate effect of distal versus proximal-distal kinsiotape on muscle strength, functional performance and gait initition profiles in athletes with and without functional ankle instability
Public title
Comparing the immediate effect of distal versus proximal-distal tape on muscle strength, functional performance and gait initition profiles in athletes with and without functional ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages of participants ranged from18 to 32 year old A history of ankle sprain in one foot (6 months-1 year needed have be passed since the initial injury and repeated ankle sprain needed to have occurred at least once during this period and participants also needed to feel ‘giving way’ in their ankles) Foot and Ankle Ability Measure (FAAM): ADL scale<90%; Sport scale <80% Fibular mobility test and fibula position in inferior tibiofibular must be normal.
Exclusion criteria:
Pain and restriction in both ankles during the test and inability to perform hopping History of surgery in ankle History of diabetes, visual disturbances, vestibular disorders, dizziness, neurological disorders, musculoskeletal trauma in lower limbs, and cognitive problems Exercise extensively before the test Inability to do the test Losing balance during the test Reluctance of participants to do the test Skin allergy to kinsio tape
Age
From 18 years old to 32 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
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 Medicine faculty of Tehran University of Medical sciences
Street address
Building No.1, the northern door of university, Poursina street, Ghods st, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1417755354
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.4255

Health conditions studied

1

Description of health condition studied
Disorder of ligament
ICD-10 code
M24.2
ICD-10 code description
Instability secondary to old ligament injury

Primary outcomes

1

Description
Strenght of the hip abductor muscles
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in nioton using handhend dynamommeter.

2

Description
Strenght of the ankle evertor muscles
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in nioton using handhend dynamommeter.

3

Description
Side Hop Test
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in second using chronometer.

4

Description
Figure of 8 Hop Test
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in second using chronometer.

5

Description
Star Excursion Balance Test
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in centimeter using tape.

6

Description
Reaction Phase Time
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in milisecond using force plate and Excel software.

7

Description
Anticipatory Phase Time
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in milisecond using force plate and Excel software.

8

Description
COP displacement in anteroposterior and mediolateral direction in anticipatory phase
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in centimeter using force plate and Excel software.

9

Description
COP displacement in anteroposterior and mediolateral direction in weight transfer phase
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in centimeter using force plate and Excel software.

10

Description
COP displacement in anteroposterior and mediolateral direction in locomotive phase
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in centimeter using force plate and Excel software.

11

Description
Speed of COP displacement in anteroposterior and mediolateral direction in anticipatory phase
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in centimeter on second using force plate and Excel software.

12

Description
Speed of COP displacement in anteroposterior and mediolateral direction in weight transfer phase
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in centimeter on second using force plate and Excel software.

13

Description
Speed of COP displacement in anteroposterior and mediolateral direction in locomotive phase
Timepoint
Before the intervention, 30 minutes after the intervention
Method of measurement
It is calculated in centimeter on second using force plate and Excel software.

Secondary outcomes

empty

Intervention groups

1

Description
Proximal- distal kinsio taping intervention: In this intervention, in addition to facilitation technique for Peroneus Longus, facilitating kinsio taping for gluteus medius is used too. For taping gluteus medius, participant lie down with the affected h
Category
Rehabilitation

2

Description
Distal Kinsio Taping Intervention: Distal kinsio taping is applied on peroneus longus muscle to facilitate it. The participant position is supine or long sitting. The anchor of kinsio tape is applied to fibular head. The ankle is planter flexed and inv
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
school of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Sara Fereydounnia, PT, Ph.D Candidate, TUMS
Street address
Number 336, Next to Safialishah Street, Piche Shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
s-fereydounnia@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadali Sahraian
Street address
Deputy for Research,6th Floor, Tehran University of Medical Sciences, Next to Ghods Street, Keshavarz Boulvard
City
Tehran
Province
Tehran
Postal code
1417755354
Phone
+98 21 8163 3698
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy for Research
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
Tehran University of Medical Sciences
Full name of responsible person
Sara Fereydounnia
Position
Pt, Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
School of Rehabilitation, No:336, Next to Safialishah Street, Piche Shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
Email
s-fereydounnia@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Azadeh Shadmehr
Position
full Professor, PT, Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
School of Rehabilitation,No:336, Next to Safialishah Street, Piche Shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
Email
shadmehr@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Feredounnia
Position
PT, Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
School of Rehabilitation of Tehran University of Medical Sciences,No:336, Next to safialishah Street, Piche Shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
Email
s-fereydounnia@razi.tums.ac.ir
Web page address

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
Because sharing IPD is useless according to the our study, We should consider all the sample size.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the primary outcome measure will be shared.
When the data will become available and for how long
These data will become available 2 months after publication.
To whom data/document is available
The results will be available for people working in academic instutions.
Under which criteria data/document could be used
people can use the data only for the rehabilitative purposes.
From where data/document is obtainable
Miss Sara Fereydounnia will be in charge of communication via E-mail: s-fereydounnia@razi.tums.ac.ir
What processes are involved for a request to access data/document
After receiving the request and the main purposes for needing the data, we will response to the request maximally to one month.
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