Protocol summary

Study aim
Determining the effect of kinesio tape and dynamic tape following fatigue in subjects with pes planus
Design
A randomized, single-blind, cross-over study of 35 participants with pes planus. A lottery will be done for randomization.
Settings and conduct
This study will be performed in the sports rehabilitation laboratory of Arak University. Each participant is evaluated in three different sessions with kinesio tape, dynamic tape, and control. The data analyzer will be blinded to the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the navicular drop of more than 10 mm, no history of lower limb injury in the last 6 months, and age between 18 and 30 years, not taking any drugs affecting the nervous system and postural control. Exclusion criteria: having a history of lower limb surgery,
Intervention groups
Intervention 1: Kinesiotype. In this condition, kinesio tape manufactured by Ares Company in South Korea is applied to the foot with the low-dye taping method. After 20 to 30 minutes, evaluations are done. After completing the evaluations, the fatigue protocol is performed, and after fatigue, the evaluations are repeated. The tape is removed from the foot and the next intervention is performed 2 to 4 days later. Intervention 2: Dynamic type: In this condition the dynamic tape (made in the USA) is applied to the foot with the low-dye taping method. After 45 minutes, evaluations are done. After completing the evaluations, the fatigue protocol is performed, and after fatigue, the evaluations are repeated. The tape is removed from the foot and the next intervention is performed 2 to 4 days later. Intervention 3: Control: In the control condition without tape, evaluations are done before and after fatigue.
Main outcome variables
Navicular drop; Foot posture index; Joint range of motion; Balance; Postural sway; Gait; Joint position sense

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200204046368N13
Registration date: 2023-06-24, 1402/04/03
Registration timing: prospective

Last update: 2023-06-24, 1402/04/03
Update count: 0
Registration date
2023-06-24, 1402/04/03
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
2023-07-04, 1402/04/13
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of kinesio tape and dynamic tape on postural sway, balance, and range of motion of the ankle joint following fatigue in people with pes planus
Public title
The effect of taping on pes planus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A navicular drop of more than 10 mm No history of lower limb injury in the last 6 months Age between 18 and 30 years Not taking any drugs affecting the nervous system and postural control
Exclusion criteria:
Having a history of lower limb surgery
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 3 interventions of kinesio tape, dynamic tape, and control are investigated and compared in a group of people with pes planus on three separate days. Each intervention is done in a separate session. The intervention that is done for each session is determined at the beginning of the session through a lottery. Then, in the next session, a draw will be made between the remaining two interventions.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not be aware of the group's classification. The information of the groups will be provided to the data analyzer in the form of numbers 1, 2, and 3, and for each participant with a code.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.ARAKU.REC.1402.006

Health conditions studied

1

Description of health condition studied
flat foot
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)

Primary outcomes

1

Description
Navicular drop
Timepoint
Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions
Method of measurement
The Brody's evaluation method

2

Description
Foot posture index
Timepoint
Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions
Method of measurement
The foot posture index (FPI-6)

Secondary outcomes

1

Description
Joint position sense
Timepoint
Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions
Method of measurement
Goniometer

2

Description
Gait
Timepoint
Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions
Method of measurement
Pedoscan

3

Description
Balance
Timepoint
Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions
Method of measurement
Y balance test

4

Description
Joint range of motion with and without weight bearing
Timepoint
Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions
Method of measurement
Goniometer , Weight-bearing lunge test

5

Description
Medial Longitudinal Arch Angle (MLAA)
Timepoint
Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions
Method of measurement
Photogrammetry

6

Description
Longitudinal arch angle
Timepoint
Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions
Method of measurement
Photogrammetry

Intervention groups

1

Description
Intervention 1: In the first intervention, the kinesio tape (Ares brand, made in South Korea) is applied to the foot by the low-dye taping method. After 20-30 minutes evaluations are done. After completing the evaluations, the fatigue protocol is performed, and after fatigue, the evaluations are repeated. The tape is removed from the foot and the next intervention is performed 2 to 4 days later.
Category
Other

2

Description
Intervention group 2: In the second intervention group, the dynamic tape (made in the USA) is applied to the foot with the low dye taping method. After 45 minutes, evaluations are done. After completing the evaluations, the fatigue protocol is performed, and after fatigue, the evaluations are repeated. The tape is removed from the foot and the next intervention is performed 2 to 4 days later.
Category
Other

3

Description
Control group: In the control group without tape, evaluations are done before and after fatigue.
Category
Other

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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