Determining the effect of kinesiotype with and without ankle strengthening exercises with bosu ball on pain, balance and big toe angle of women with hallux valgus.
Design
A clinical trial with two experimental groups and one control group, one blind, randomized, will be conducted on 45 women with hallux valgus and flat foot.
Settings and conduct
Group (kinesiotype): It will be applied on the big toe for four weeks (three sessions per week) for a maximum of 24 hours. Before using kinesiotype, passive stretching is done using massage for two minutes focusing on the muscles to be taped, and also according to the elasticity of the tape, the amount of elasticity (while applying on on the big toe) increases. Group (kinesiotype and ankle strengthening exercises with bosu ball): for four weeks (three sessions a week), the researcher applied kinesiotype on the subject's big toe for 24 hours, and these people should also perform ankle strengthening exercises with bosu ball give The control group will not receive any intervention. This trial will be conducted in the sports hall in Arak city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1: Women who have mild and moderate hallux valgus (15 to 30 degrees) with flat feet. 2: Absence of any orthopedic problems in the lower limbs. 3: Absence of any congenital diseases in the lower limbs.
Intervention groups
Experimental group 1: kinesiotype and ankle strengthening exercises with Bosu ball, experimental group 2: kinesiotype and group 3: control
Main outcome variables
Kinesiotype and ankle strengthening exercises with bosu ball have an effect on pain, balance and big toe angle in women with hallux valgus.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230619058528N1
Registration date:2023-10-15, 1402/07/23
Registration timing:prospective
Last update:2023-10-15, 1402/07/23
Update count:0
Registration date
2023-10-15, 1402/07/23
Registrant information
Name
Zahra Geramipour
Name of organization / entity
The univesity of arak
Country
Iran (Islamic Republic of)
Phone
+98 86 3403 9071
Email address
zahragerami938@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of kinesio typing and ankle resistance training with Bosu ball on pain, balance and big toe angle of women with Hallux Valgus.
Public title
The effect of kinesio typing and ankle strengthening exercises with bosu ball on hallux valgus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have flat feet in addition to mild and moderate hallux valgus (15 to 30 degrees).
Absence of any inflammatory disease in the lower limbs such as rheumatoid arthritis and gout...
Absence of any orthopedic problems such as fractures and dislocations in the lower limbs
Absence of any congenital diseases in the lower limbs
Exclusion criteria:
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The research community will consist of women with hallux valgus and flat feet. The number of samples was obtained using G-power software for all three groups of 45 people (15 control people, 15 kinesiotype people and 15 ankle strengthening exercises). The groups were selected by simple random.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are unaware of the division of control and experimental groups.
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Using a goniometer
Secondary outcomes
1
Description
The balance
Timepoint
At the beginning of the study and after four weeks of intervention
Method of measurement
Singel_Leg Balance test
2
Description
The pain
Timepoint
At the beginning of the study and after four weeks of intervention
Method of measurement
Visual Analogue Scale
3
Description
Flat foot
Timepoint
At the beginning of the study and after four weeks of intervention
Method of measurement
The amount of navicular bone loss
Intervention groups
1
Description
1: intervention group (kinesiotype and kinesiotype with ankle strengthening exercises) 2: control group
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hygieia Corrective Movement Center
Full name of responsible person
Azadeh Ghasemi
Street address
Hygieia Correctional Movement Center, Golha Alley, Abbas Abad St, Arak Town
City
Arak
Province
Markazi
Postal code
3819655357
Phone
+98 86 3402 2840
Email
zahragerami938@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University
Full name of responsible person
Shahnaz Shahrjardi
Street address
Faculty of Sport Sciences, Department of Sports Pathology, karbala Boulevard, Basij Square, Sardasht, Arak University, Arak
City
Atak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Email
shahjerdi_shahnaz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University
Full name of responsible person
Shahnaz Shahrjardi
Position
PhD in sports medicine
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sport Sciences, Department of Sports Pathology, karbala Boulevard, Basij Square, Sardasht, Arak University, Arak
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Fax
Email
shahjerdi_shahnaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University
Full name of responsible person
Shahnaz Shahrjardi
Position
PhD in sports medicine
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sport Sciences, Department of Sports Pathology, karbala Boulevard, Basij Square, Sardasht, Arak University, Arak
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Fax
Email
shahjerdi_shahnaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University
Full name of responsible person
Shahnaz Shahrjardi
Position
PhD in sports medicine
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sport Sciences, Department of Sports Pathology, karbala Boulevard, Basij Square, Sardasht, Arak University, Arak
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 9024
Fax
Email
shahjerdi_shahnaz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is 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
Title and more details about the data/document
All data will be accessible after the publication of the research.
When the data will become available and for how long
Since 2023
To whom data/document is available
All people from university researchers, professors and people with hallux valgus can receive this research.
Under which criteria data/document could be used
A person who intends to study this research can send a message to the researcher via email, and the person can also use the information in the article.
From where data/document is obtainable
First, email: shahrjerdi.shanaz@gmail.com, then call the following number: 09161520974, and finally, you can visit the Arak University library located in Sardasht, Karbala Boulevard, in front of the flour factory.
What processes are involved for a request to access data/document
The applicant can receive the documents after sending an email to the researcher and receiving confirmation from the researcher.