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Comparison Between Effects of Tibialis Posterior Kinesio Taping and Fibularis Longus Kinesio Taping on Dynamic Components and Foot Posture in Young Individuals with Flexible Flatfoot

Protocol summary

Study aim
The study aims to evaluate the effects of Kinesio taping on two functional muscles of the foot and its impacts on balance, physical performance, posture, and dynamic components of the foot.
Design
Two arm parallel group randomised single-blinded trial on 30 patients
Settings and conduct
This study will be conducted at the school of rehabilitation, Tehran university of medical sciences. First, people will be evaluated, and then they will undergo single-session Kinesio taping on the mentioned muscles. After 30 minutes, they will be reevaluated. People will be unaware of the group to which they will be allocated.
Participants/Inclusion and exclusion criteria
People who will be included in this study have the required criteria as follows: being eighteen to forty years old; obtaining the desired scores in the navicular drop test and foot posture index; and having flexible foot arch; with a body mass index between 20-25. Also, people with pregnancy; and those who suffer from ankle injury; surgery; pain; foot deformity; difficulty in standing and walking; and Kinesio tape sensitivity will not be included in the study.
Intervention groups
For the tibialis posterior muscle Kinesio taping, the person lies in a supine position and actively dorsiflexes and everts the ankle, and at the same time, Kinesio tape will be applied on the muscle. Accordingly, for the fibularis longus muscle Kinesio taping, the person lies in a supine position and actively plantarflexes and inverts the ankle, and again at the same time, Kinesio tape will be applied on the muscle. A piece of I-shaped tape with 35 percent tension plus no tension at both ends will be used.
Main outcome variables
Navicular drop test score; foot posture index score; Y balance test score; timed up and go score; dynamic components

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211018052805N1
Registration date: 2021-11-17, 1400/08/26
Registration timing: prospective

Last update: 2021-11-17, 1400/08/26
Update count: 0
Registration date
2021-11-17, 1400/08/26
Registrant information
Name
Alireza Tahmasbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 1442
Email address
ar-tahmasebi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-13, 1400/09/22
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Between Effects of Tibialis Posterior Kinesio Taping and Fibularis Longus Kinesio Taping on Dynamic Components and Foot Posture in Young Individuals with Flexible Flatfoot
Public title
Evaluation of the effectiveness of Kinesio tape on flexible flatfoot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-40 year old people Navicular drop test >= 10 mm Foot posture index score between +6 to +12 Positive toe raise test BMI between 20-25
Exclusion criteria:
Ankle injury in the last six months History of foot surgery Foot injury due to systemic, inflammatory and infectious diseases Foot deformities include hallux valgus, hammer toe, claw toe Pregnancy Ankle pain during the study Static standing and walking problems Kinesio tape sensitivity Refuse to participate in the study or cancel continuing treatment
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial assessments, the people will be randomly assigned to one of the two groups of tibialis posterior Kinesio taping and fibularis longus Kinesio taping (method: simple randomization - unit: individual). An envelope containing blue paper and another envelope containing red paper (randomization tool: sealed envelope) will be given to each person. Each person choosing the envelope containing blue or red paper will be assigned to the tibialis posterior Kinesio taping group or fibularis longus Kinesio taping group, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be single-blinded. In this way, the participants do not know to which group they will be allocated. However, the therapist assessing the outcome measures and the data analyzer know each participant’s group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine, Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-10-18, 1400/07/26
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.771

Health conditions studied

1

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

Primary outcomes

1

Description
Navicular drop test score
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Index card and ruler

2

Description
foot posture index score
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Observation

3

Description
Y balance test score
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Meter

4

Description
Timed up and go test score
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
stopwatch

5

Description
mean length/width of gait line
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Moticon insole and software

6

Description
mean and maximum total force of stance phase
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Moticon insole and software

7

Description
mean double support time
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Moticon insole and software

8

Description
mean stance and swing duration
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Moticon insole and software

9

Description
Center of pressure amplitude in mediolateral direction
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Moticon insole and software

10

Description
Center of pressure amplitude in anteroposterior direction
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Moticon insole and software

11

Description
Center of pressure standard deviation in mediolateral direction
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Moticon insole and software

12

Description
Center of pressure standard deviation in anteroposterior direction
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Moticon insole and software

13

Description
mean center of pressure velocity
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Moticon insole and software

14

Description
Center of pressure trace length
Timepoint
At the beginning of the study and after 30 minutes of intervention
Method of measurement
Moticon insole and software

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: For the tibialis posterior muscle Kinesio taping, the person lies in a supine position and actively dorsiflexes and everts the ankle, and at the same time, Kinesio tape will be applied on the muscle. Kinesio taping will be started from the half of the tibia bone, passing behind the medial malleolus. Ultimately the Kinesio taping process will be finished at the fifth metatarsal head after passing over the navicular bone. A piece of I-shaped tape (TEMTEX, South Korea) with 35 percent tension plus no tension at both ends will be used. Then, people will rest for 30 minutes in a sitting position. After 30 minutes, reevaluation will be performed. A physical therapist will apply Kinesio tape for all of the people.
Category
Rehabilitation

2

Description
Intervention group 2: For the fibularis longus muscle Kinesio taping, the person lies in a supine position and actively plantarflexes and inverts the ankle, and at the same time, Kinesio tape will be applied on the muscle. Kinesio taping will be started from the fibular head, passing behind the lateral malleolus. Ultimately the Kinesio taping process will be finished at the first metatarsal base. A piece of I-shaped tape (TEMTEX, South Korea) with 35 percent tension plus no tension at both ends will be used. Then, people will rest for 30 minutes in a sitting position. After 30 minutes, reevaluation will be performed. A physical therapist will apply Kinesio tape for all of the people.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Alireza Tahmasbi
Street address
Central Organization of Tehran university of medical sciences, Corner of Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 7752 8468
Email
ar-tahmasebi@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3639
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Alireza Tahmasbi
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche Shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
ar-tahmasebi@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Tahmasbi
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche Shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
ar-tahmasebi@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Tahmasbi
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche Shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
ar-tahmasebi@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after making individuals unidentified.
When the data will become available and for how long
The access period starts three months after the articles are published.
To whom data/document is available
For researchers working in academic, scientific, and hospital institutions
Under which criteria data/document could be used
It's for researchers who work in the field of lower limb biomechanical impairments and the field of Kinesio tape.
From where data/document is obtainable
Applicants for documentation can contact Mr. Alireza Tahmasbi via email: ar-tahmasebi@razi.tums.ac.ir
What processes are involved for a request to access data/document
Once they have the necessary criteria, the information will be provided to them within a month.
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