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The effect of kinesio tape and dynamic tape on range of motion, functional performance and balance in athletes with chronic ankle instability with and without fatigue

Protocol summary

Study aim
Determining the effect of kinesio tape and dynamic tape on the investigated factors in athletes with chronic ankle instability with and without fatigue
Design
Randomized, single-blind clinical trial, Phase II. This study will be conducted on 34 athletes with chronic ankle instability. One of the four interventions is applied in each session. Before starting the work in each session, a lottery is held to select the intervention of that session.
Settings and conduct
This study will be conducted in the sports rehabilitation laboratory of Arak University. Each participant in this study will undergo intervention in four different sessions. At first, the objectives of the study will be explained to the participants in general. But in the evaluation sessions, subjects are blinded regarding the selected intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering from chronic ankle instability, scoring more than 24 from the Cumberland Ankle Instability Tool Questionnaire, not participating in the ankle treatment program at the same time as the study, the absence of severe lower limb injuries, no history of ankle fractures and surgery in Six months leading up to the study, no history of neurological disease, vestibular or visual impairment. Exclusion criteria: not completing the study process, skin sensitivity to tape.
Intervention groups
This study includes one group. On four different days, the participants will be subjected to four interventions including kinesio tape, dynamic type, placebo, and control.
Main outcome variables
The functional performance; balance; joint range of motion; postural sway; gait; Perceived stability; joint position sense

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200204046368N9
Registration date: 2023-05-13, 1402/02/23
Registration timing: prospective

Last update: 2023-05-13, 1402/02/23
Update count: 0
Registration date
2023-05-13, 1402/02/23
Registrant information
Name
Zahra Raeisi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3492
Email address
z_raisi13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-20, 1402/02/30
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of kinesio tape and dynamic tape on range of motion, functional performance and balance in athletes with chronic ankle instability with and without fatigue
Public title
The effect of dynamic type and kinesio tape on chronic ankle instability
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from chronic ankle instability Score greater than 24 on the Cumberland Instability Instrument Failure to participate in the ankle treatment program at the same time as the study Absence of musculoskeletal disorders and other severe lower limb injuries No history of neurological disease, vestibular or vision disorder No history of ankle fracture and ankle surgery in the six months leading up to the study At least six months have passed since the last ankle sprain injury
Exclusion criteria:
A score of less than 24 on the Cumberland Instability Instrument Participating in the ankle treatment program at the same time as this study Existence of musculoskeletal disorders and other severe lower limb injuries Having a history of neurological disease, vestibular or vision disorder Having a history of ankle fracture or ankle surgery in the six months leading up to the study
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 34
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The control, placebo, kinesio, and dynamic tape methods will be used in this study, but the participants will not be explained which kind of tape was applied.
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University
Street address
Basij square
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.ARAKU.REC.1402.005

Health conditions studied

1

Description of health condition studied
Chronic ankle instability
ICD-10 code
M25.37
ICD-10 code description
Other instability, ankle and foot

Primary outcomes

1

Description
Functional performance
Timepoint
Before and after fatigue
Method of measurement
functional performance tests: side hop, 6-meter crossover hop, figure-of-eight hop, triple crossover hop, and lateral hop.

2

Description
Balance
Timepoint
Before and after fatigue
Method of measurement
Y balance test

3

Description
Joint range of motion with and without weight bearing
Timepoint
Before and after fatigue
Method of measurement
Goniometer , Weight-bearing lunge test

4

Description
Postural sway
Timepoint
Before and after fatigue
Method of measurement
Pedoscan

Secondary outcomes

1

Description
Perceived stability
Timepoint
Before and after fatigue
Method of measurement
Visual analogue scale questionnaire

2

Description
Gait
Timepoint
Before and after fatigue
Method of measurement
Pedoscan

3

Description
Joint position sense
Timepoint
Before and after fatigue
Method of measurement
Goniometer

Intervention groups

1

Description
Intervention group: The present study has one group. Evaluations are done in four separate sessions. In each session, one of the control, placebo, dynamic tape and Kinesio tape methods is applied to the ankle. Tests are performed before and after the fatigue protocol in each of these situations.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak university
Full name of responsible person
Zahra Raeisi
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3277 4031
Email
Z_raisi13@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak university
Full name of responsible person
Hamed Safikhani
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 2000
Email
d-research@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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