Investigation of the performance variables of the musculoskeletal system extracted from biomechanical data in functional activities in women with flat feet before and after the functional fatigue protocol in two kinesiotape and sham tape groups
Design
The way of dividing people into two kinesiotape or sham tape groups will be according to block randomization. The sample size is 24. There is no trial phase. A clinical trial with a control group with parallel groups. Bilaterally blind.
Settings and conduct
The place of performance is in the research center for the treatment of movement disorders at Tarbiat Modares University. The random arrangement in the group is Kinsiotape and sham tape. The participants and the person responsible for data collection are unaware of the study group allocation. The intervention will be in two sessions, one week apart.
Participants/Inclusion and exclusion criteria
Entry conditions: Active non-athletes women suffering from bilateral flat feet
normal body mass index (18.5-24.9)
Age 18-40
Conditions of non-entry: history of any lasting orthopedic or neurological injury
The difference in the actual length of the lower body is more than 1.5 centimeter
Significant congenital malformations
Intervention groups
It includes Kinesiotape (intervention) or sham tape (control). The first session will be done in the condition without fatigue in two situations with and without tape and the second session will be done in the condition with fatigue in two situations with and without the jump tape. Our fatigue protocol consists of 5 sets of consecutive lateral jumps.
Main outcome variables
Biomechanical variables related to the performance of the musculoskeletal system during functional activities such as jumping and walking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201128049511N4
Registration date:2022-11-28, 1401/09/07
Registration timing:registered_while_recruiting
Last update:2022-11-28, 1401/09/07
Update count:1
Registration date
2022-11-28, 1401/09/07
Registrant information
Name
Sahar Boozari
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 5053
Email address
s.boozari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Kinesiotape on the Performance of the Musculoskeletal System in Women with Flexible Flatfeet in Conditions with and without Fatigue
Public title
Effect of Elastic Bands on the Human Body Performance in Women with Flatfeet
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Active non-athlete women (light aerobic activity three times a week), suffering from bilateral flexible flatfeet
Normal Body Mass Index (18.5-24.9)
Age 18-40
Exclusion criteria:
History of any lasting orthopedic or neurological damage in the lower limbs and spine
The difference in the actual length of the lower body is more than 1.5 centimeter
Significant congenital malformations in the lower limbs
Body mass index more than 24.9
Pain in the lower limbs or spine during the research period
Obvious deformities such as hallux valgus, genu varus, genu valgum, and internal rotation of the thigh
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be done by the block randomization method. In the first session, people are randomly assigned to either kinesiotape or sham tape groups. The number of blocks will be 4, 6, and 8, and randomly be placed in sealed envelopes. For the random assignment, code 1 for the kinesiotape group and code 0 for the sham tape group are placed in the envelopes. subjects will choose a closed envelope and are placed in the kinesiotape or sham tape group based on the selected code.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the kinesiotape group, the Kinesiotape, which is an elastic therapeutic tape, is attached to the posterior tibialis muscle, the transverse arch, and the inner longitudinal arch of the foot with a special tension to correct the arch and improve muscle function. For the sham group, a piece of tape is attached to the inside of the ankle, that is, in a place other than the treatment area and without tension. Study participants are not aware of whether they are in the kinesiotape or sham group and are not familiar with the treatment. The engineer responsible for data recording also does not have information about how to stick the Kinesiotape, which is a therapeutic task and is blinded to the people in the two groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2022-08-29, 1401/06/07
Ethics committee reference number
IR.MODARES.REC.1401.109
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
Biomechanical variables related to body movement activities such as walking and jumping
Timepoint
Before and after the functional fatigue protocol
Method of measurement
Force plate device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intervention includes kinesiotape. In the first session, after learning how to jump, the subject performs the jump in the condition without tape. Then the tape is attached to the subject and this time the jump is done with the tape. Two situations with and without tape will be randomly selected for people. After a week, the second session will begin. In the second session, the fatigue protocol will be applied randomly in two conditions with and without tape. Our fatigue protocol consists of 5 sets of consecutive jumps, and when the person cannot continue the protocol, it means that the person is tired.
Category
Treatment - Other
2
Description
For the sham tape group, a kinesiotape piece is used on the inside of the ankle. In the first session, after learning how to jump, the subject performs the jump in the condition without tape. Then the tape is attached to the subject and this time the jump is done with the tape. Two situations with and without tape will be randomly selected for people. After a week, the second session will begin. In the second session, the fatigue protocol will be applied randomly in two conditions with and without tape. Our fatigue protocol consists of 5 sets of consecutive jumps, and when the person cannot continue the protocol, it means that the person is tired.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Treatment Center for Movement Disorders of Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
Web page address
http://ptmodares.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tarbiat Modares
Full name of responsible person
Amir Abdollahzadeh
Street address
Tarbiat Modares University, Jalal Al Ahmad, Pol Nasr, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Fax
+98 21 8288 3101
Email
Res@modares.ac.ir
Web page address
https://res.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tarbiat Modares
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
The University of Tarbiat Modares
Full name of responsible person
Zeynab Nickpey
Position
Master's Student in Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
zeynabnickpey@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Sahar Boozari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran, Tehran, Jalal Al ahmad Highway, Nasr Bridge, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
Web page address
http://ptmodares.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Sahar Boozari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran, Tehran, Jalal Al ahmad Highway, Nasr Bridge, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
Web page address
http://ptmodares.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
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared after people are not identified.
When the data will become available and for how long
After the results are published, the access phase started six months later
To whom data/document is available
Researchers in academic and research organizations will also have access to the data.
Under which criteria data/document could be used
to do scientific research
From where data/document is obtainable
to do scientific research, Sahar Boozari, Jalal Al Ahmad Highway, Tarbiat Modares University, s.boozari@modares.ac.ir, 00982182885053
What processes are involved for a request to access data/document
Send the project plan, and if approved, it will be sent following a complete evaluation of the persons and organizations involved in the project.