Protocol summary

Study aim
Aim: To compare the effects of Kinesio taping and arch-support foot orthosis on postural stability during the transition from double-leg to single-leg stance.
Design
This is a randomized crossover. Thirty participants will be randomly assigned to one of six possible intervention sequences using a permuted block randomization method with a fixed block size of six.
Settings and conduct
This study will be conducted at the School of Rehabilitation Science, Iran University of Medical Sciences. Using a randomized crossover design, each participant will be assessed under three conditions: a control condition (no intervention), a tape condition, and an insole condition. Sequence of these three conditions will be randomized according to one of six possible orders. A minimum washout period of 24 hours will be considered between sessions. Because of obvious nature of interventions is not possible to blind participants or outcome assessors, however, the statistician will not aware of assigned groups.
Participants/Inclusion and exclusion criteria
Inclusion: Age between 18 and 35 years, ability to stand and walk, bilateral flatfoot, BMI less than 30, FPI-6 score ≥ 6, Navicular Drop ≥ 10 mm, literate (able to read and write), moderate activity level based on the IPAQ questionnaire. Exclusion: Foot deformities and vestibular disorders, use of medications or substances affecting the central nervous system, history of surgery within the last 6 months, high intensity physical activity within 12 hours before the test.
Intervention groups
Each participant will be assessed under three conditions: control (no intervention), insole, and kinesio tape, in a randomized order across three separate sessions.
Main outcome variables
COP displacement and velocity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260810070608N1
Registration date: 2026-08-24, 1405/06/02
Registration timing: prospective

Last update: 2026-08-24, 1405/06/02
Update count: 0
Registration date
2026-08-24, 1405/06/02
Registrant information
Name
Amir mohammad Shooryabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4452 7096
Email address
shooryabi.a@iums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-05, 1405/06/14
Expected recruitment end date
2027-03-11, 1405/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Immediate Effects of Foot Insole and Kinesio Taping on Postural Stability Using the Double-Leg to Single-Leg Stance Transition Test in Adults with Flexible Flatfoot
Public title
Effect of interventions on flatfoot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18–35 years Ability to stand and walk Bilateral flatfoot BMI less than 30 Foot Posture Index (FPI-6) score ≥ +6 Navicular Drop Test ≥ 10 mm Able to read and write in Persian Moderate physical activity level (IPAQ questionnaire)
Exclusion criteria:
Foot deformities (hallux valgus, hammer toe, etc.) and vestibular disorders Use of medications/substances affecting the central nervous system History of musculoskeletal injury within the last 6 months High-intensity physical activity within 12 hours before test
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
This study will employ a randomized, three-period, three-treatment crossover design. Eligible participants will be randomly assigned to one of six possible intervention sequences (IBT, ITB, BIT, BTI, TIB, TBI) in a 1:1:1:1:1:1 allocation ratio using a permuted block randomization method with a fixed block size of six. Each block will contain all six sequences exactly once in a randomly determined order. Five complete blocks will be generated to achieve the target sample size of 30 participants. To ensure allocation concealment, group assignments will be placed in sequentially numbered, opaque, sealed envelopes by an independent administrator. Envelopes will be opened sequentially only after participant enrollment and completion of all baseline procedures, immediately before the first intervention session.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Rehabilitation Sciences, Iran University of Medical Sciences
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷۱۵۴۵۹
Approval date
2026-07-22, 1405/04/31
Ethics committee reference number
IR.IUMS.REHAB.REC.1405.016

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
The mean of COP displacement
Timepoint
Assessments will be performed immediately after a 30-minute period(familiarization) following the application of each intervention, across 3 sessions with different conditions, each separated by an interval of at least 24 hours from the previous session.
Method of measurement
Force plate, model 9260AA6, manufactured by Kistler

2

Description
Mean absolute COP velocity
Timepoint
Assessments will be performed immediately after a 30-minute period(familiarization) following the application of each intervention, across 3 sessions with different conditions, each separated by an interval of at least 24 hours from the previous session.
Method of measurement
Force plate, model 9260AA6, manufactured by Kistler

3

Description
Mean peak absolute COP velocity
Timepoint
Assessments will be performed immediately after a 30-minute period(familiarization) following the application of each intervention, across 3 sessions with different conditions, each separated by an interval of at least 24 hours from the previous session.
Method of measurement
Force plate, model 9260AA6, manufactured by Kistler

4

Description
Mean COP displacement during contralateral push-off phase
Timepoint
Assessments will be performed immediately after a 30-minute period(familiarization) following the application of each intervention, across 3 sessions with different conditions, each separated by an interval of at least 24 hours from the previous session.
Method of measurement
Force plate, model 9260AA6, manufactured by Kistler

5

Description
Mean COP excursion range during contralateral push-off phase
Timepoint
Assessments will be performed immediately after a 30-minute period(familiarization) following the application of each intervention, across 3 sessions with different conditions, each separated by an interval of at least 24 hours from the previous session.
Method of measurement
Force plate, model 9260AA6, manufactured by Kistler

Secondary outcomes

1

Description
temporal parameters during transition task including mean time to new stability point, mean duration of contralateral limb push-off phase
Timepoint
Assessments will be performed in each session, under one of (control/no intervention; insole; kinesio tape) conditions, a 24-hours washout period will be considered between sessions. There will be a 30-minute familiarization time with interventions in each session.
Method of measurement
force plate

Intervention groups

1

Description
Insole condition. Due to the crossover design of this study, this group represents one of the 3 conditions available. All 30 participants in the study receive this condition according to the sequence group to which they are assigned. This study has a total of 6 sequence groups, which determine the order in which the conditions (insole, Kinesio tape, no intervention) are received in each session.To evaluate the immediate effect of the condition, the participant performs the test 30 minutes after receiving the condition (familiarization period).
Category
Treatment - Other

2

Description
Kinesio tape condition. Due to the crossover design of this study, this group represents one of the 3 conditions available. All 30 participants in the study receive this condition according to the sequence group to which they are assigned. This study has a total of 6 sequence groups, which determine the order in which the conditions (insole, Kinesio tape, no intervention) are received in each session.To evaluate the immediate effect of the condition, the participant performs the test 30 minutes after receiving the condition (familiarization period).
Category
Treatment - Other

3

Description
No intervention condition. Due to the crossover design of this study, this group represents one of the 3 conditions available. All 30 participants in the study receive this condition according to the sequence group to which they are assigned. This study has a total of 6 sequence groups, which determine the order in which the conditions (insole, Kinesio tape, no intervention) are received in each session.To evaluate the immediate effect of the condition, the participant performs the test 30 minutes after receiving the condition (familiarization period).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Amir mohammad Shooryabi
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21 2222 8051
Fax
Email
Shooryabi.a@iums.ac.ir
Web page address
https://rehab.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Majid Safa
Street address
Tehran, Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86790
Email
safa.m@iums.ac.ir
Web page address
https://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
Amir Mohammad Shooryabi
Position
MSc Student in Orthotics and Prosthetics
Latest degree
Bachelor
Other areas of specialty/work
Orthotics and Prosthetics
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21 2222 8051
Email
amirshooryabi5@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Azadinia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21 2222 7124
Email
azadinia.fatemeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Mohammad Shooryabi
Position
MSc Student in Orthotics and Prosthetics
Latest degree
Bachelor
Other areas of specialty/work
Orthotics and Prosthetics
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21 2222 7124
Email
amirshooryabi5@gmail.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
No - There is not 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
our research findings will be shared with all researchers, and practitioners. We will publish our research findings in scientific journals.
When the data will become available and for how long
All documents can be shared 1 year after article publication.
To whom data/document is available
Researchers and health practitioners
Under which criteria data/document could be used
Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published articles.
From where data/document is obtainable
Fatemeh Azadinia
What processes are involved for a request to access data/document
Send email to corresponding author
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