Protocol summary

Study aim
The aim of this study is determining the effectiveness of combined kinesiotape of lower extremity muscles on functional performance in athletes with chronic ankle instability. In this study, we will compare the effectiveness of combined kinesiotaping of fibularis longus, gluteus maximus and gastrocnemius on lower extremity functional tests, before and after and 24 hours later of using kinesiotape in athletes with chronic ankle instability.
Design
Randomized Placebo-controlled, parallel group trial, single blind,
Settings and conduct
Single blinding in athletes with chronic ankle instability based on receiving actual kinesiotape or placebo kinesiotape
Participants/Inclusion and exclusion criteria
Athletes with having score less than 25 according to Cumberland Ankle Instability Tool (CAIT), report at least once the giving way of affected ankle joint in the past year and having unilateral chronic ankle sprain will be included and the subjects with skin allergy when using kinesotape and the existence of swelling in ankle region and positive talar tilt and anterior drawer tests will be excluded.
Intervention groups
Intervention group: The kinesiotape is applied to the skin along the fibularis longus, gastrocnemius, gluteus maximus muscles from the beginning to the end of the muscle (with 35% maximum tension). Control group: placebo group: The kinesiotape without tension is applied to the skin along the fibularis longus, gastrocnemius,gluteos maximus muscles.
Main outcome variables
Double countermovement vertical jump; Single countermovement jump; Lateral hop test; Single hop test; Star excursion balance test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180728040618N1
Registration date: 2018-10-20, 1397/07/28
Registration timing: prospective

Last update: 2018-10-20, 1397/07/28
Update count: 0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Holakoo Mohsenifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 6933
Email address
mohsenifar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combined kinesiotape of lower extremity muscles on functional performance in athletes with chronic ankle instability
Public title
Effect of kinesiotape on functional performance in in athletes with chronic ankle instability
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having score less than 25 according to Cumberland Ankle Instability Tool (CAIT) Report at least once the giving way of affected ankle joint in the past year Having unilateral chronic ankle sprain
Exclusion criteria:
They have had skin allergy to use of kinesotape. The existence of swelling in ankle region Having deformity in ankle Positive talar tilt and anterior drawer tests Range of motion limitation in ankle joint History of fracture and dislocation in affected limb pregnancy
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 13
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization, Individual, Computer Software, Allocation Concealment
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinding in athletes with chronic ankle instability based on receiving actual kinesiotape or placebo kinesiotape
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemmat Expy
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-08-28, 1396/06/06
Ethics committee reference number
IR.IUMS.SMD.REC 1396.9411452004

Health conditions studied

1

Description of health condition studied
Chronic ankle instability
ICD-10 code
M25.373
ICD-10 code description
Other instability, unspecified ankle

Primary outcomes

1

Description
Double countermovement vertical jump
Timepoint
Before tape, 20 min after taping and 24 houres after taping
Method of measurement
meter

2

Description
Single countermovement jump
Timepoint
Before tape, 20 min after taping and 24 houres after taping
Method of measurement
meter

3

Description
Lateral hop test
Timepoint
Before tape, 20 min after taping and 24 hours after taping
Method of measurement
Cornometer

4

Description
Single hop test
Timepoint
Before tape, 20 min after taping and 24 hours after taping
Method of measurement
meter

5

Description
Star excursion balance test
Timepoint
Before tape, 20 min after taping and 24 hours after taping
Method of measurement
meter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The kinesiotape is applied to the skin along the fibularis longus, gastrocnemius, gluteus maximus muscles from the beginning to the end of the muscle (with 35% maximum tension).
Category
Rehabilitation

2

Description
Control group: placebo group: The kinesiotape without tension is applied to the skin along the fibularis longus, gastrocnemius,gluteos maximus muscles.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Aryarad Sport Club
Full name of responsible person
Sahar Safari
Street address
Zarei Ave, Golestan Town
City
Shiraz
Province
Fars
Postal code
7189937966
Phone
+98 71 3650 6251
Email
Safarisahar92@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakouti
Street address
Next to Milad Tower, Hemmat Expy
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Holakoo Mohsenifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, Next to Milad Tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 86709
Email
Mohsenifarpt@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Holakoo Mohsenifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, Next to Milad Tower, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 86709
Email
Mohsenifarpt@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Holakoo Mohsenifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, Next to Milad Tower, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 86709
Email
Mohsenifarpt@gmail.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
There is no further information
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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