The aim of the study is to determine the effect of kinsiotaping on pain and balance in the subjects with moderate hallux valgus.
Design
60 volunteers with moderate hallux valgus will be randomly assigned to two parallel intervention and control group. Randomization method is Permuted block randomization and the random allocation software (Excel) will be used as randomization instrument.
Settings and conduct
The volunteer subjects with moderate hallux valgus who will be referred to Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences, participate in the study.
Participants/Inclusion and exclusion criteria
The main inclusion criteria are the volunteers aged between 20 and 40 years old with moderate hallux valgus. The main exclusion criteria are unwillingness to participate in the project; mild and severe hallux valgus; any traumatic, inflammatory and infectious pathology in the lower extremity;any problem in visiual, auditory and vestibular system; neuromuscular deficit and inability to understand the test procedure.
Intervention groups
In the intervention group taping will be applied in Y shape on the first metatarsus for mechanical correction with 50% tension in 3 sessions during 10 days. The control group does not receive any intervention.
Main outcome variables
The main outcome measures including the displacement of center of pressure and visual analogue scale (VAS) will be assessed in both groups before and after 10 days intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150602022539N7
Registration date:2018-05-23, 1397/03/02
Registration timing:registered_while_recruiting
Last update:2018-05-23, 1397/03/02
Update count:0
Registration date
2018-05-23, 1397/03/02
Registrant information
Name
Ziaeddin Safavi Farokhi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
zsafavi@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of kinsiotaping on pain and balance in the subjects with moderate hallux valgus
Public title
The effect of kinsiotaping in the subjects with hallux valgus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteers aged between 20 and 40 years old
Subjects with moderate hallux valgus
Exclusion criteria:
Unwillingness to participate in the project
Mild and severe hallux valgus
Any traumatic, inflammatory and infectious pathology in the lower extremity
Any deformity of foot and toes such as club toe and hammer toe
Problems with visiual, auditory and vestibular system
Neuromuscular deficit
Inability to understand the test procedure
Age
From 20 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Permuted block randomization
Randomization unit: Person
Stratified randomization: Not done
Randomization instrument: ٌRandom allocation software (Excel)
Random sequence generation: Used random blocks, each block containing 4 people and allocated a number from 1 to 6 to each block
Allocation concealment: Because of physiotherapy interventions for patients, allocation concealment is not possible
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی سمنان
Street address
Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
5319899951
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.SEMUMS.REC.1396.274
Health conditions studied
1
Description of health condition studied
Hallux valgus deformity
ICD-10 code
M20.10
ICD-10 code description
Hallux valgus (acquired), unspecified foot
Primary outcomes
1
Description
Displacement of center of pressure
Timepoint
Before and after 10 days intervention
Method of measurement
Millimeter
2
Description
Visual Analogue Scale (VAS)
Timepoint
Before and after 10 days intervention
Method of measurement
Millimeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Taping will be applied in Y shape on the first metatarsus for mechanical correction with 50% tension in 3 sessions during 10 days.
Category
Rehabilitation
2
Description
Control group: No intervention
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Street address
in front of Helal Ahmar, Mashahir Square, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3332 2332
Email
ziasafavi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
5319899951
Phone
+98 23 3345 1336
Email
Parviz.kokhaei@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.om
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
ziasafavi@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
Undecided - It is not yet known if there will be a plan to make this available