Protocol summary

Study aim
To investigate the immediate effects of different types of tape (Kinesiotaping®, athletic taping) on functional performance in athletes with chronic ankle instability.
Design
A clinical trial with a control group, with crossover groups of 16 patients, not blinded, randomized with taking concealed envelop from inside of a bag.
Settings and conduct
Each participant receives all interventions with a different sequence in 5 sessions with intervals and acts as her control group. (For example, participant1; in session1: kinesiotaping, 3 days later in session 2: athletic tape, 3 days later in session 3: Kinesio-placebo taping and 3 days later in session 4: Placebo athletic taping and 3 days later in session5: without tape). The order of the sequence of interventions and the performance tests are determined for each participant separately and randomly (taking a sealed envelope from within the bag). The first selection of samples for taking part in the study will be performed by convenience sampling from athletic clubs in the academic and non-academic areas of Tehran province. Then all functional tests for all participants will be performed in 5 different conditions in 5 separate days in random order from 3-4 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: female athletes between 18 to 45; at least three ankle sprains during the past year; score of ≤ 24 on the Cumberland Ankle Instability Tools (CAIT) Exclusion criteria: fracture or any acute ankle sprain in last three months; CAI in both side; pregnancy; neurological or vestibular disorder;anterior cruciate ligament injury; participated in a rehabilitation program.
Intervention groups
Kinesiotaping; Athletic taping; Placebo kinesiotaping; Placebo athletic taping; Without taping.
Main outcome variables
Modified Star Excursion Test; Hoping Test designed by Amanda; Figure-8 Hoping Test; Vertical Jump test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180516039688N1
Registration date: 2018-05-31, 1397/03/10
Registration timing: registered_while_recruiting

Last update: 2018-05-31, 1397/03/10
Update count: 0
Registration date
2018-05-31, 1397/03/10
Registrant information
Name
Marjan Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
m_askari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-07, 1397/02/17
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the immediate effect of athletic taping and kinesiotaping techniques on functional performance tests of female athletes with chronic ankle instability
Public title
The comparison of the immediate effect of athletic taping and kinesiotaping techniques on functional performance of athletes with chronic ankle instability
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least three ankle sprain during last year Scor of ≤ 24 of on the Cumberland Ankle Instability Tools (CAIT) Age between18 to 45
Exclusion criteria:
Fracture Acute ankle sprain Chronic ankle instability in both side Pregnancy Neurological or vestibular problem Anterior cruciate ligament injury Participation in rehabilitation program
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
The ordering of interventions and performance tests in each session is performed randomly and it is determined by removing the sealed envelope from within a bag.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
All participants receive all interventions alternately with different sequences in 5 sessions.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz Uneversity of Medical Sciences
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Postal Code: 71345-1978
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2017-10-22, 1396/07/30
Ethics committee reference number
IR.SUMS.REC.1396.119

Health conditions studied

1

Description of health condition studied
Chronic ankle instability
ICD-10 code
M24.2
ICD-10 code description
Disorder of ligament

Primary outcomes

1

Description
Modified Star Excursion Test
Timepoint
Measure in all sessions with intervals of three to four days
Method of measurement
Tape meter (centimeters)

2

Description
Hoping Test: this test was designed by Amanda et al. to evaluate agility and control movement of a limb on unstable surfaces.
Timepoint
Measure in all sessions with intervals of three to four days
Method of measurement
Chronometer

3

Description
Figure-8 Hoping Test
Timepoint
Measure in all sessions with intervals of three to four days
Method of measurement
Chronometer

4

Description
Vertical Jump
Timepoint
Measure in all sessions with intervals of three to four days
Method of measurement
Tape meter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: siotaping® Method: This method is based on taping used for lateral ankle sprain.The foot is placed in a comfortable resting position with slight plantar flexion and the first I-strip is applied from middle of foot to just below the tibial tuberosity along muscle Anterior Tibialis. The second Y-strip is originated just above medial malleolus and passed under the heel and ended at fibular head point just near the insertion of first strip. The third one is placed on anterior side of ankle joint between medial and lateral malleolus. The last strip, is stretched under the foot, 6 inches above medial and lateral malleolus. All strips are stretched to approximately 100% of their resting length.
Category
Rehabilitation

2

Description
Intervention group: Athletic taping Method: In this method, first we fasten pre-wrap on the target joint (ankle). Then, we use two pieces of 5 cm width tape and implement them on the beginning and the end of pre-wrap as the anchors. Third, we implement one strip from medial to lateral crossing under the heel, and the other strip from medial to lateral crossing behind the heel in order to support the ankle. Finally, medial and lateral heel locks techniques are used.
Category
Rehabilitation

3

Description
Intervention group: Placebo-Kinesio taping: This method of taping is almost the same as the Kinesio taping, but we don't allow any tension along the tape.
Category
Rehabilitation

4

Description
Intervention group: Placebo-athletic taping: This method of taping is almost the same as the athletic taping method, but there is no structural correction in the ankle joint.
Category
Rehabilitation

5

Description
Control group: with out taping
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Shafipour Stadium
Full name of responsible person
Marjan Askari
Street address
East 4th alley , North VafaAzar Ave., Ayatollah Kashani Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1481945956
Phone
+98 21 4497 8277
Email
m_askari@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Marjan Askari
Position
M.Sc. student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
Shiraz
Province
Fars
Postal code
1733-71345
Phone
+98 71 3627 1551
Fax
Email
askari.marjan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohsen Razeghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
Shiraz
Province
Fars
Postal code
1733-71345
Phone
+98 71 3627 1551
Email
razeghm@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marjan Askari
Position
M. Sc. Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
m_askari@sums.ac.ir

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
The data of the participant alone is useless.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
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
Not applicable
Title and more details about the data/document
The results of primary outcomes will be shared.
When the data will become available and for how long
The start of the access period will be two months after the publication of the results.
To whom data/document is available
Data will be available to academic researchers.
Under which criteria data/document could be used
Once accessed, individuals have the right to use the study protocol for rehabilitation purposes.
From where data/document is obtainable
Marjan Askari will be responsive through email. askari.marjan@gmail.com m_askari@sum
What processes are involved for a request to access data/document
After receiving the request and mentioning the reasons for the request, the data will be answered within a maximum of one month.
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