Protocol summary

Study aim
The purpose of this study is to investigate the effect of leg kinesio taping on plantar pressure variables, balance and proprioception in athletes with shin splint.
Design
Clinical trial with placebo control group, with arallel groups, single blinded, randomized
Settings and conduct
The tests will be carried out by the specialists at the Sport Rehabilitation Laboratory of Bu-Ali Sina University in Hamadan, and then interventions will take place in the gym. During the testing, the participant will be unaware of the main purpose of the research.
Participants/Inclusion and exclusion criteria
The inclusion criteria included: Having exercise-induced pain in the leg on the posteromedial tibia border, Pain on palpation of the posteromedial tibia for at least five centimeters, and exclusion criteria including: History of fractures and lower limb surgery during the last six months, Participate in leg rehabilitation programs over the past six months.
Intervention groups
"Intervention group": kinesio taping group (kinesio tape with violet color ATEX brand made in South Korea) will be applied to the muscles of the tibialis anterior with %75 tension for 24 hours, then plantar pressure, balance and ankle proprioception will be measured before, immediately and one day after the kinesio taping. "Control Placebo group": control placebo group (kinesio tape with yellow color ATEX brand made in South Korea) intervention as the first intervention group but without tension will be applied to the muscles of the tibialis anterior for 24 hours, then plantar pressure, balance and ankle Proprioception will be measured before, immediately and one day after the kinesio taping. therefore, the first group really applied kinesiotape and the second group will be applied as placebo kinesiotape.
Main outcome variables
Disorder in plantar pressure distribution, balance and ankle proprioception.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210629051737N1
Registration date: 2021-09-06, 1400/06/15
Registration timing: retrospective

Last update: 2021-09-06, 1400/06/15
Update count: 0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
amir shayesteh
Name of organization / entity
Bu Ali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 25 3890 4910
Email address
a.shayesteh@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-31, 1399/10/11
Expected recruitment end date
2021-03-06, 1399/12/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of leg kinesio taping on plantar pressure variables, balance and proprioception in athletes with shin splint
Public title
The effect of leg kinesio taping on plantar pressure variables, balance and proprioception
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having exercise-induced pain in the leg on the posteromedial tibia border Pain on palpation of the posteromedial tibia for at least five centimeters
Exclusion criteria:
History of fractures and lower limb surgery during the last six months Participate in leg rehabilitation programs over the past six months
Age
From 20 years old to 32 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by simple method and by lottery. The participant randomly selected one of the two envelopes with the words "intervention" and "placebo control" that will receive the intervention of the same group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will not know in which group will they be placed because in both groups the kinesiotape will be glued to the same area of the leg and in both groups, the size of the attached tape was the same .the only difference between the two group was that in the kinesiotape group was taped by the Kinesiotape with tension, while the placebo group was taped with Kinesiotape but with-out any tension and patients did not notic any difference in kinesiotaping tension.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Approval date
2020-02-25, 1398/12/06
Ethics committee reference number
IR.BASU.REC.1398.046

Health conditions studied

1

Description of health condition studied
Shin Splint
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plantar pressure variables
Timepoint
Before the intervention begins, immediately after the end of the intervention, One day after the end of the intervention
Method of measurement
RSscan Device

2

Description
Balance
Timepoint
Before the intervention begins, immediately after the end of the intervention, One day after the end of the intervention
Method of measurement
Y-Balance Test

3

Description
Proprioception
Timepoint
Before the intervention begins, immediately after the end of the intervention, One day after the end of the intervention
Method of measurement
Goniometer

Secondary outcomes

1

Description
Disorder in Plantar pressure Distribution
Timepoint
Before the intervention begins, immediately after the end of the intervention, One day after the end of the intervention
Method of measurement
RSscan Device

2

Description
ImBalance
Timepoint
Before the intervention begins, immediately after the end of the intervention, One day after the end of the intervention
Method of measurement
Y-Balance Test

3

Description
Disorder in Proprioception
Timepoint
Before the intervention begins, immediately after the end of the intervention, One day after the end of the intervention
Method of measurement
Goniometer

Intervention groups

1

Description
Intervention group: kinesio taping group (kinesio tape with violet color ATEX brand made in South Korea) will be applied to the muscles of the tibialis anterior with %50 tension for 24 hours, then plantar pressure, balance and ankle proprioception will be measured before, immediately and one day after the kinesio taping.
Category
Rehabilitation

2

Description
Control group: control placebo group with kinesiotape (kinesio tape with yellow color ATEX brand made in South Korea) intervention as the first intervention group but without tension will be applied to the muscles of the tibialis anterior for 24 hours, then plantar pressure, balance and ankle Proprioception will be measured before, immediately and one day after the kinesio taping.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
committee of table tennis of Hamedan
Full name of responsible person
Amir Shayesteh
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
a.shayesteh@phe.basu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
gholam hossein majzoobi
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 2072
Email
majzoobi@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bu Ali Sina 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
Bu Ali Sina University
Full name of responsible person
Amir Shayesteh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
a.shayesteh@phe.basu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Amir Shayesteh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
a.shayesteh@phe.basu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Amir Shayesteh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
a.shayesteh@phe.basu.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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